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Financial Deception in Healthcare Highlights
AHealthcareZ - Healthcare Finance Explained
@ahealthcarez
Dec 4, 2022
This video provides an in-depth exploration of financial deception within the healthcare industry, arguing that such practices are not unique to healthcare but are common business strategies across all sectors. Dr. Eric Bricker, the speaker, begins by establishing this context, referencing an economist from the University of Chicago Business School, Albert Carr, who posited that executives are often compelled to practice some form of deception—through misstatements, concealment, or exaggeration—to gain a competitive advantage. Bricker applies this framework to healthcare, asserting that to think the business side of healthcare is immune to such tactics due to its life-and-death nature is naive. The presentation then systematically details over 30 examples of financial deception, categorized by different stakeholders within the healthcare ecosystem. The core of the video progresses through specific examples of deceptive practices across various healthcare entities. It starts with physicians, discussing the significant financial gifts from pharmaceutical and medical device companies, including food, stock options, and grants, and how these can potentially bias continuing medical education. Moving to hospitals, Bricker highlights the practice of "charge capture" and "upcoding," citing the dramatic 300% increase in sepsis coding after Medicare increased its Diagnosis-Related Group (DRG) reimbursement for the condition, implying a financial incentive rather than a true increase in incidence. The discussion then shifts to health insurance, unraveling the complexity and often misleading nature of deductibles, particularly the concept of multiple individual and family deductibles, both in-network and out-of-network, and the "embedded deductible" structure that makes it difficult for families to meet their stated family deductible. Further examples delve into the pharmaceutical industry's strategies to extend market exclusivity and delay generic competition. This includes the practice of filing multiple patents on a single medication, as seen with Humira, to prolong its patent life beyond the standard 17 years. Additionally, Bricker explains "pay-to-delay" schemes, where brand-name pharmaceutical companies financially compensate generic manufacturers to postpone the release of generic versions of drugs. The final category of deception focuses on private equity firms, illustrating how they circumvent "corporate practice of medicine" laws, which typically forbid corporations from owning physician practices, by establishing shell management companies. This allows private equity giants like KKR and Blackstone to acquire large physician groups, effectively employing tens of thousands of providers. The video concludes with a "buyer beware" message, urging individuals to be actively engaged and critically think about healthcare transactions, while acknowledging the inherent difficulty of this approach, especially for those who are ill or suffering. Key Takeaways: * **Deception as a Business Strategy:** The video posits that deception, including conscious misstatements, concealment of facts, or exaggeration (bluffing), is a common and often effective business strategy across all industries, including healthcare. Ignoring this reality can put an entity at a disadvantage. * **Financial Influence on Physicians:** Pharmaceutical and medical device companies provide substantial financial gifts to doctors, totaling $2.4 billion annually, with the majority being food. These gifts, along with stock options and grants, can potentially bias medical education and prescribing practices. * **Hospital Upcoding for Reimbursement:** Hospitals engage in "charge capture" practices that can lead to upcoding. A notable example is the 300% increase in sepsis coding after Medicare increased its DRG reimbursement for the condition, suggesting a financial incentive drove the diagnostic shift rather than a true epidemiological change. * **Complexity of Insurance Deductibles:** Health insurance deductibles are often deceptively complex. Families typically face four deductibles (individual in-network, individual out-of-network, family in-network, family out-of-network), and the "embedded deductible" structure means multiple family members must individually meet their deductibles before the family deductible is satisfied, leading to significant unexpected out-of-pocket costs. * **Pharmaceutical Patent Manipulation:** Pharmaceutical companies employ strategies to prolong drug patents beyond the standard 17 years, such as filing dozens of patents on a single medication. This extends market exclusivity, delaying generic competition and keeping drug prices high. * **"Pay-to-Delay" Generic Drug Schemes:** Brand-name pharmaceutical companies often pay generic drug manufacturers to delay the release of generic versions of medications. This anti-competitive practice prevents more affordable alternatives from entering the market, benefiting the brand-name company financially. * **Private Equity's Circumvention of Corporate Practice Laws:** Private equity firms bypass "corporate practice of medicine" laws, which prohibit corporations from owning physician practices, by creating shell management companies. These shell companies, nominally led by a physician, then acquire and manage large groups of providers, effectively allowing private equity to control healthcare delivery. * **Scale of Private Equity Acquisitions:** Major private equity firms like KKR and Blackstone have acquired massive physician groups, such as Envision (25,000 providers for $10 billion) and TeamHealth (20,000 providers for $6 billion), demonstrating the significant financial investment and control private equity exerts over healthcare providers. * **The "Buyer Beware" Imperative:** Given the prevalence of deception, individuals are urged to adopt a "Caveat Emptor" (buyer beware) mindset, actively engaging, verifying information, and thinking critically about healthcare services and costs. * **Challenges of Individual Vigilance:** The video acknowledges that relying solely on individual vigilance is an imperfect solution, as patients who are in pain, suffering, or emotionally distraught are often not in a position to think critically or advocate effectively for themselves. Key Concepts: * **Deception as a Business Strategy:** The idea that misrepresentation or concealment can be a deliberate and effective tactic in business negotiations and operations. * **Charge Capture:** The process in healthcare facilities of documenting and translating services rendered into billable codes for reimbursement. * **DRG (Diagnosis-Related Group) Reimbursement:** A system used by Medicare and other insurers to classify hospital cases into groups with similar resource consumption and then pay a fixed amount per case. * **Embedded Deductible:** A feature in family health insurance plans where individual family members must meet a certain portion of the deductible before the family deductible is met, even if the family's total out-of-pocket expenses exceed the family deductible amount. * **Patent Evergreening:** Strategies used by pharmaceutical companies to extend the patent life of their drugs beyond the initial term, often through minor modifications or additional patents. * **Pay-to-Delay (Reverse Payment Settlements):** Agreements where a brand-name drug manufacturer pays a generic drug manufacturer to delay bringing its generic product to market. * **Corporate Practice of Medicine Laws:** State laws that prohibit corporations from directly employing physicians or owning medical practices, intended to prevent non-medical entities from interfering with clinical judgment. Examples/Case Studies: * **Humira Patent Extension:** Cited as an example of a pharmaceutical company using multiple patents to extend a drug's market exclusivity well beyond the standard 17 years. * **Sepsis Coding Increase:** The 300% increase in sepsis coding after Medicare increased reimbursement for DRGs related to sepsis, illustrating how financial incentives can influence diagnostic coding. * **KKR and Envision:** KKR's acquisition of Envision, a group of 25,000 providers, for $10 billion, demonstrating private equity's large-scale ownership of physician practices. * **Blackstone and TeamHealth:** Blackstone's purchase of TeamHealth, comprising 20,000 providers, for $6 billion, further highlighting the trend of private equity investment in healthcare provider groups.
Episode 6: Data Managers: Driving the Future of Clinical Research
Veeva Systems Inc
/@VeevaSystems
Dec 2, 2022
This video directly addresses the evolving landscape of clinical data management within the pharmaceutical industry, the strategic importance of data, and the increasing role of advanced technologies like AI/ML. This video explores the transformative journey of clinical data management, highlighting its shift from a back-office function to a strategic imperative driving the future of clinical research. Richard Young and Mayank Anand discuss how data professionals' roles are evolving in an era of decentralized data, emphasizing the critical need for data to optimize trial protocols, operations, and patient access to treatments. The conversation delves into GSK's innovative approach to data strategy and management, which integrates various data functions and prioritizes an enterprise mindset, stakeholder collaboration, and patient-centricity. A key theme is the operationalization of AI/ML in clinical research, moving beyond buzzwords to real-world applications, while also considering ethical implications and the need for continuous professional evolution. Key Takeaways: * **Strategic Elevation of Data Management:** Clinical data management is no longer a secondary function but is now "front and center" in optimizing clinical trials, requiring professionals to drive the future of research rather than just support it. * **AI/ML as an Operational Reality:** AI and Machine Learning are no longer just buzzwords but are becoming integral to clinical data management, offering significant opportunities for efficiency and transformation, necessitating discussions around ethical AI and regulatory alignment. * **Integrated Data Strategy for End-to-End Oversight:** Leading pharmaceutical companies like GSK are adopting a holistic "Data Strategy and Management" approach, consolidating functions such as data acquisition, medical coding, core data management, centralized monitoring, and data analytics to ensure comprehensive and strategic data oversight. * **Enterprise Mindset and Collaborative Innovation:** Successful data transformation requires an "enterprise mindset" that considers all stakeholders (clinical operations, biostats, pharmacovigilance, etc.) and fosters collective ownership, utilizing agile methodologies to accelerate delivery and manage complex interdependencies. * **"Total Experience" for Adoption and Impact:** Designing new technologies and processes with "Total Experience" (TX) in mind—encompassing change management, communication, and the impact on all end-users, including patients and investigators—is crucial for successful adoption and achieving desired outcomes. * **Evolving Role of Data Professionals:** The traditional "data manager" role is transforming into future-oriented positions like "data scientist" or "data engineer," emphasizing continuous learning and adaptation to new technologies, rather than fearing job displacement by AI. * **Challenges in Infrastructure and Data Democratization:** Significant industry challenges persist in modernizing legacy infrastructure and achieving broader data democratization, highlighting areas for future innovation and collaborative efforts to unlock the full potential of clinical data.
Patient Advocacy with Graith Care - Priscilla Romans
Self-Funded
@SelfFunded
Nov 29, 2022
This video provides an in-depth exploration of patient advocacy through a conversation with Priscilla Romans, CEO and Founder of Graith Care. Romans discusses the origin story of her independent patient advocacy firm, detailing her personal and professional journey from a nursing background and entrepreneurial family to identifying critical gaps in the healthcare system. The core purpose of Graith Care is to empower patients by providing transparency, control, and comprehensive options for their healthcare decisions, ultimately aiming to improve outcomes, efficiency, and cost-effectiveness. The discussion highlights the systemic challenges within the current healthcare model, where patients often feel disempowered, uninformed, and constrained by institutional policies and financial incentives. Romans elaborates on the practical application of patient advocacy, explaining how Graith Care operates as an independent entity, free from hospital or insurance company affiliations, to solely serve the patient's best interest. She describes the process of clients engaging with Graith Care, from initial contact to being matched with one of their 20+ specialized advocates who possess diverse backgrounds in critical care, insurance, naturopathy, and therapy. A significant portion of the conversation focuses on real-world scenarios, including complex hospital cases where patients' primary ailments are overlooked due to COVID-19 protocols and incentives, and situations where patients seek alternative or complementary treatments not offered by their primary care providers. Graith Care acts as a "second set of eyes," helping families navigate medical decisions, plan discharges, and even facilitate critical patient transfers between facilities when standard care pathways are insufficient or undesired by the patient. The discussion also delves into the future of patient advocacy, emphasizing the growing need for a collaborative approach that integrates allopathic (conventional) medicine with alternative and holistic treatment options. Romans advocates for a shift in mindset within the healthcare industry, urging for greater recognition and coverage of complementary therapies, such as high-dose IV ascorbic acid for cancer patients, which are often dismissed despite being relatively inexpensive and potentially beneficial. She attributes the bias against such treatments to doctors' limited training in nutrition and holistic approaches, coupled with the systemic pressures of short patient visit times and productivity scores. Romans passionately argues for a return to patient-centered care, where informed consent and individual choice are paramount, and where collaboration between all healthcare stakeholders—from physicians to nurses and advocates—prioritizes the patient's well-being over institutional constraints. Key Takeaways: * **Empowering Patient Control and Transparency:** Graith Care's mission is to restore control and transparency to healthcare consumers, ensuring patients are fully informed of all options to make the best decisions for their unique situations. This counters the common feeling of disempowerment within the complex healthcare system. * **Independent Advocacy Model:** Graith Care operates independently of hospitals and insurance companies, allowing advocates to provide unbiased advice and recommendations. This independence removes the "blinders of policies and procedures" that often constrain institutional providers. * **Diverse Advocacy Services:** The firm offers over 40 types of advocacy services, ranging from navigating insurance claims and appeals to finding transplant advocates, exploring holistic alternatives, and managing pediatric to adult care needs. This breadth addresses the multifaceted challenges patients face. * **Addressing Systemic Gaps in Care:** The video highlights critical gaps, such as the neglect of primary medical issues due to hospital incentives for specific protocols (e.g., COVID-19), and the lack of comprehensive discharge planning, which contributes to high readmission rates. * **Facilitating Patient Transfers:** Graith Care assists patients in transferring to facilities that offer desired treatments or protocols not available at their current hospital. This often involves complex logistics, collaboration with physicians, and sometimes legal pressure to ensure patient choice is honored. * **Challenging the Allopathic-Only Mindset:** Romans advocates for integrating complementary and alternative treatment options alongside conventional medicine, citing examples like high-dose IV ascorbic acid for cancer patients. She emphasizes that these are not "fufu" but scientifically supported options that should be covered by insurance. * **Physician Constraints and Bias:** Doctors often lack comprehensive training in nutrition and holistic treatments, and are constrained by short appointment times (e.g., 15 minutes) and productivity metrics. This systemic pressure limits their ability to discuss broader treatment options or engage in deeper patient-physician relationships. * **Proactive vs. Reactive Healthcare:** Graith Care emphasizes proactive planning to prevent health crises, arguing that it is more cost-effective and leads to better outcomes than reacting to problems. This approach aims to keep individuals out of the "hands of crisis" where bad decisions are often made. * **Importance of a Collaborative Network:** The success of Graith Care relies on a strong network of diverse professionals, including nurses, insurance experts, naturopaths, physical therapists, and occupational therapists, who can collectively address the wide range of patient needs. * **Transparency in Pricing and Services:** Graith Care maintains transparent pricing and FAQs online, and commits to quick follow-up, especially for critical hospital cases, demonstrating a commitment to accessibility and responsiveness. * **The "Molly and Jim" Case Study:** This example illustrates the challenges of patient choice in a high-tier hospital where a doctor refused to consider alternative treatments or transfer, highlighting the need for external advocacy to ensure patient options are presented and pursued. * **Impact of Information Suppression:** The speaker's experience with a viral TikTok video promoting cash price negotiations being taken down suggests a broader issue of information suppression regarding patient empowerment and alternative healthcare options. Key Concepts: * **Patient Advocacy:** The act of supporting and representing patients to ensure their rights, wishes, and needs are met within the healthcare system, especially when they are unable to do so themselves. * **Informed Consent:** The ethical and legal requirement that patients understand the risks, benefits, and alternatives of a proposed medical procedure or treatment before agreeing to it. * **Independent Advocacy:** Advocacy services provided by an entity not affiliated with hospitals, insurance companies, or other healthcare providers, ensuring unbiased representation of the patient's interests. * **Allopathic Medicine:** The conventional Western medical system that treats diseases with drugs, surgery, or radiation. * **Complementary and Alternative Medicine (CAM):** A group of diverse medical and health care systems, practices, and products that are not generally considered part of conventional medicine. "Complementary" means used together with conventional medicine; "alternative" means used in place of conventional medicine. * **Cash Price Negotiations:** The practice of patients asking for and negotiating the direct cost of medical services or pharmaceuticals, often bypassing insurance, which can sometimes lead to lower prices. Examples/Case Studies: * **COVID-19 Hospital Protocols:** Patients admitted for primary issues (e.g., colitis) being diagnosed with COVID-19 via PCR tests, leading to neglect of their original ailment due to hospital incentives for COVID protocols. Graith Care helps families redirect focus to the primary issue and immune support. * **Patient Transfers for Alternative Treatments:** Cases where patients in critical care (e.g., with COVID-19) desire specific "Frontline doctors protocols" (e.g., IV ascorbic acid, Ivermectin) not offered by their hospital. Graith Care facilitates transfers to facilities willing to provide these options, involving complex logistics like air ambulances. * **"Molly and Jim" Story:** A patient in a high-tier South Dakota hospital whose doctor refused to offer or facilitate alternative treatments or a transfer. Graith Care intervened, navigating institutional resistance to successfully transfer the patient, emphasizing the patient's right to choose. * **Cancer Treatment Alternatives:** Discussion of cancer patients seeking to combine conventional treatments (chemo, radiation) with complementary options like high-dose IV ascorbic acid for immune support, highlighting the need for oncologists to be open to these alternatives.
Medicare Advantage Overpayments
AHealthcareZ - Healthcare Finance Explained
@ahealthcarez
Nov 27, 2022
This video provides an in-depth exploration of the systemic issue of government overpayments to Medicare Advantage (MA) plans, highlighting a significant financial and regulatory challenge within the U.S. healthcare system. Dr. Eric Bricker, the speaker, begins by detailing the Centers for Medicare & Medicaid Services (CMS) risk adjustment methodology, which dictates payments to private MA plans based on a beneficiary's health conditions. He illustrates how this system financially incentivizes MA plans to identify and potentially exaggerate the severity of chronic conditions, leading to increased payments from CMS. The video then progresses to discuss the legal and auditing failures surrounding these overpayments, culminating in a critical look at the political and financial forces that appear to perpetuate the problem. The core of the issue, as presented, lies in the financial incentives embedded within the risk adjustment model. MA plans receive a base rate per member, which is then adjusted upwards if the member has more chronic conditions, reflecting higher anticipated healthcare costs. Conversely, healthier individuals result in lower payments. This structure, while designed to account for varying healthcare needs, creates a strong incentive for plans to "game the system" by making beneficiaries appear sicker than they might be. The Department of Justice has taken action, suing major insurers like Cigna and Elevance (Anthem) for allegedly inflating Medicare payments through such exaggerations. However, Dr. Bricker points out a deeper, more troubling problem: CMS's own auditing process is severely lacking, with the most recent audits dating back a decade (2011-2013), identifying $650 million in overpayments that CMS has largely failed to act upon or even disclose. The lack of transparency and action by CMS is a central theme. The Kaiser Family Foundation (KFF) had to resort to a Freedom of Information Act (FOIA) request, and subsequently a three-year lawsuit, to compel CMS to release its own audit findings. This resistance from CMS suggests a reluctance to reveal or address the overpayment issue, which Dr. Bricker attributes to either incompetence or political pressure. He further introduces a controversial perspective by highlighting the significant financial ties between AARP and Medicare Advantage plans, particularly UnitedHealthcare. AARP receives substantial royalty payments from endorsing healthcare products, including MA plans, which far exceed its member dues. This financial incentive, Dr. Bricker speculates, could potentially influence AARP's stance on the quiet maintenance of the "Medicare Advantage gravy train," thereby contributing to the political inertia surrounding reform. Ultimately, the video concludes with a pessimistic outlook on immediate change. With Medicare Advantage enrollment rapidly growing and projected to surpass traditional Medicare, the overpayments—estimated at $7 billion more than traditional Medicare in 2019—are hastening the depletion of the Medicare Part A trust fund, which is projected to run out by 2028. Despite these alarming financial implications and evidence of systemic issues, Dr. Bricker argues that political will for reform is absent, largely due to high re-election rates for incumbents and a lack of public outcry. He suggests that meaningful change is unlikely until a full-blown crisis forces the issue, echoing the sentiment of "never let a crisis go to waste." Key Takeaways: * **Medicare Advantage Risk Adjustment Incentives:** CMS's payment model for Medicare Advantage plans, based on risk scores reflecting chronic conditions, creates a strong financial incentive for plans to maximize the reported sickness of their members to increase payments. * **Allegations of System Gaming:** The Department of Justice and the Office of Inspector General have sued major Medicare Advantage providers like Cigna and Anthem for allegedly exaggerating beneficiary health conditions to inflate payments from CMS. * **CMS Audit Deficiencies:** CMS's internal audits of Medicare Advantage plans are severely outdated, with the most recent data from 2011-2013. These audits identified $650 million in overpayments, but CMS has taken minimal action to recover these funds. * **Lack of Transparency from CMS:** CMS initially refused to release its own audit findings, requiring the Kaiser Family Foundation to file a Freedom of Information Act request and a subsequent three-year lawsuit to obtain the information. * **Potential Influence of AARP:** AARP receives substantial royalty payments (over $750 million annually in 2020) from endorsing healthcare products, including Medicare Advantage plans, particularly from UnitedHealthcare, raising questions about its potential influence on policy and the lack of reform. * **Financial Burden on Medicare:** Medicare Advantage plans are significantly more expensive for Medicare than traditional Medicare, with overpayments estimated at $7 billion more in 2019, contributing to the accelerated depletion of the Medicare Part A trust fund. * **Impending Trust Fund Depletion:** The Medicare Part A trust fund, which pays for hospital services, is projected to run out by 2028, a crisis that is being hastened by the overpayments to Medicare Advantage plans. * **Political Inertia:** Despite clear evidence of overpayments and financial strain, there is a perceived lack of political will to address the issue, partly due to high re-election rates for congressional representatives and a lack of public demand for change. * **Growth of Medicare Advantage:** Medicare Advantage enrollment has nearly doubled in less than a decade, now covering almost half of all Medicare beneficiaries, indicating its growing impact on the overall healthcare system. * **No Immediate Change Expected:** The speaker concludes that fundamental changes to the risk adjustment methodology or the auditing process are unlikely in the near future, suggesting that the "Medicare Advantage gravy train" will continue until a significant crisis forces action. Tools/Resources Mentioned: * NPR * Commonwealth Fund * Reuters * FierceHealthcare * OpenSecrets * Kaiser Family Foundation (KFF) * Freedom of Information Act (FOIA) Key Concepts: * **Medicare Advantage (MA):** Private health insurance plans that contract with Medicare to provide Part A and Part B benefits. * **Centers for Medicare & Medicaid Services (CMS):** The federal agency that administers Medicare, Medicaid, and the Children's Health Insurance Program. * **Risk Adjustment:** A methodology used by CMS to adjust payments to MA plans based on the health status and demographic characteristics of their enrollees, aiming to pay more for sicker patients and less for healthier ones. * **Department of Justice (DOJ):** The federal department responsible for enforcing the law, including prosecuting cases of fraud against government programs. * **Office of Inspector General (OIG):** An independent oversight body within the Department of Health and Human Services (HHS) that combats waste, fraud, and abuse in HHS programs. * **AARP:** A non-profit organization advocating for the rights and interests of older Americans, which also generates significant revenue through royalty payments from endorsing various products and services, including Medicare Advantage plans. * **Medicare Part A Trust Fund:** The federal fund that pays for hospital inpatient care, skilled nursing facility care, hospice care, and some home health care. Examples/Case Studies: * **DOJ Lawsuits:** The Department of Justice has sued Cigna and Elevance (Anthem) for allegedly inflating Medicare payments by exaggerating beneficiary sickness. * **Kaiser Family Foundation vs. CMS:** KFF had to sue CMS under the Freedom of Information Act to obtain CMS's own audit findings regarding Medicare Advantage overpayments, a legal battle that lasted three years. * **AARP and UnitedHealthcare:** AARP receives substantial royalty payments from UnitedHealthcare for endorsing its Medicare Advantage plans, which often carry the AARP brand name.
Webinar: Actionable milestones to connect and control project performance throughout CTMS & eTMF
Flex Databases
/@Flexdatabases
Nov 21, 2022
This webinar, presented by Flex Databases, provides an in-depth exploration of how "actionable milestones" can be effectively utilized within their integrated CTMS (Clinical Trial Management System) and eTMF (electronic Trial Master File) to connect and control project performance throughout clinical trials. The core purpose is to demonstrate how a synchronized milestone system can optimize project management, streamline document tracking, automate financial processes, and enhance reporting capabilities, ultimately leading to greater transparency and efficiency in clinical operations. The presenters, Montasser (Project Manager) and Kenya (from Flex Databases), highlight the system's ability to address common pain points such as miscommunication, delays in financial processes, and challenges in assessing project completeness. The session begins by establishing the fundamental need for milestones in project management, emphasizing their role in meeting deadlines, allocating resources, increasing study visibility, and demonstrating success for financial targets. A key theme is the concept of "rolling milestones" and "connected vessels," illustrating how milestones, once defined, automatically synchronize and travel across various modules of the Flex Databases system. This includes the Project Catalog (initial source), eTMF (for document completeness), CTMS (for site-level data), and Project Management & Budgeting (for financial tracking). The webinar progresses by detailing the implementation of milestones in each of these areas, providing specific examples and demonstrating the system's functionalities through brief video demos. Throughout the presentation, the speakers underscore the system's unique methodologies, such as the automatic "Roll-Ups" feature, where site-level milestone achievements (e.g., first patient in) automatically update country and global/study level milestones, taking the earliest date for the global achievement. This significantly reduces manual data entry and potential errors in multi-country studies. Furthermore, the integration of milestones with budgeting and invoicing rules allows for automated generation of invoices based on milestone completion, ensuring timely cash flow management. The final segment focuses on the comprehensive reporting tool, which leverages all interconnected milestone data to generate predefined and custom reports, charts, and graphs for assessing performance, identifying bottlenecks, and troubleshooting. This holistic approach aims to provide all stakeholders, from project managers to finance teams and sponsors, with real-time, actionable insights into trial progress and performance. Key Takeaways: * **Centralized Milestone Management:** Milestones are established at the project's inception within a "Project Catalog" and serve as the initial, single source of truth for project progress, supporting resource allocation and enhancing study visibility. * **Automated Milestone Synchronization:** Once defined, milestones automatically "travel" and synchronize across various modules of the Flex Databases system, including eTMF, CTMS, and Project Management & Budgeting, ensuring consistent data across all departments. * **eTMF Completeness by Milestone:** Milestones are integrated into the eTMF to automatically assess document completeness. The system indicates expected and missing documents for specific milestones, guiding teams on what needs to be uploaded or finalized to meet deadlines and ensure regulatory readiness. * **Dynamic CTMS Integration:** Site-level data entered into the CTMS (e.g., a PI indicating the first patient recruited, or a CRA uploading an SQV report) automatically updates the corresponding milestones across the entire system, eliminating miscommunication and manual tracking. * **Hierarchical Milestone Roll-Ups:** The system supports three levels of milestones: site, country, and global/study. Site-level milestone achievements automatically roll up to country and global levels, with the system identifying and applying the earliest date for the global achievement, which is crucial for international studies. * **Flexible Milestone Timelines:** Milestones can be defined with three key dates: "Planned Date" (initial target), "Forecast Date" (team's expectation), and "Actual Date" (when achieved), allowing for comprehensive tracking against original plans and current predictions. * **Automated Milestone-Based Invoicing:** The system enables the creation of invoicing rules tied to milestone achievements. When a milestone is reached, the finance team is immediately aware, and invoices can be automatically generated for sponsors, optimizing cash flow and reducing manual effort. * **Task Dependency Automation:** Project tasks can be linked to specific milestones. If a milestone's date changes (e.g., the planned date is adjusted), the dates of all connected tasks automatically update, maintaining the integrity and accuracy of the project plan. * **Comprehensive Reporting Capabilities:** All synchronized milestone data feeds into a powerful "Report Tool," allowing users to generate predefined reports (e.g., overdue, upcoming milestones) or create custom reports with charts and graphs to assess project performance, identify bottlenecks, and troubleshoot based on real data. * **Configurable Grace Periods for Documents:** For documents associated with eTMF milestones, the system allows for configurable grace periods (e.g., days for upload, days for review) in the system settings, providing flexibility while still tracking compliance. * **Support for Diverse Invoicing Milestones:** The system accommodates both project-driven and financially-driven milestones for invoicing, offering flexibility to align with various contractual payment terms beyond just project progress. * **Future Logic Checks for Milestones:** While not currently implemented, the idea of introducing logic checks (e.g., ensuring a patient is screened before being "in") for default milestones was acknowledged as a valuable future development, indicating a focus on data integrity. **Tools/Resources Mentioned:** * **Flex Databases:** The overarching platform providing the CTMS, eTMF, Project Catalog, Project Management & Budgeting, Report Tool, and Investigators and Site Management modules. * **DIA (Drug Information Association):** Mentioned as a source for recommended eTMF structures, which the Flex Databases system can accommodate. **Key Concepts:** * **Actionable Milestones:** Project measurements that, upon achievement, trigger specific actions, updates, or assessments within the system, driving project progress and automation. * **CTMS (Clinical Trial Management System):** A software system designed to manage and track various operational aspects of clinical trials, including site and patient data. * **eTMF (electronic Trial Master File):** A secure, electronic repository for all essential clinical trial documents, crucial for regulatory compliance and audit readiness. * **Roll-Ups:** A data aggregation feature where information from lower-level entities (e.g., site-specific milestone dates) automatically updates higher-level entities (country or global study milestones). * **Connected Vessels:** A metaphor used to describe the seamless, real-time data synchronization and flow between different modules of the Flex Databases system. * **Planned Date:** The initial target date for a milestone, often agreed upon during study planning or in contracts. * **Forecast Date:** The project team's current prediction for when a milestone will be achieved. * **Actual Date:** The definitive date on which a milestone was successfully completed. * **Lap:** The calculated difference in days between planned/forecast dates and the actual achievement date, used to measure performance against schedule. **Examples/Case Studies:** * **eTMF Document Management:** The "clinical infrastructure ready" milestone is used to demonstrate how the system tracks required documents (e.g., TMF plan, monitoring plan, quality plan, list of SOPs). It highlights how the system shows expected and missing documents, along with their deadlines, to ensure timely completion. * **Site-level Data to Global Milestone:** A scenario where a site in Germany recruits its first patient on November 2nd. This date, entered by the Principal Investigator (PI) in the "Investigators and Site Management" module of CTMS, automatically updates the "first subject in" milestone in the Project Catalog and other relevant system parts. * **Automated Invoice Generation:** An example of an invoicing rule tied to the "first site activated" milestone. Upon this milestone's achievement, the system automatically generates an invoice for the sponsor based on pre-defined budget assumptions and tasks. * **Performance Reporting:** Custom reports are shown comparing "site activation to first subject in" periods across different sites and countries, displaying planned vs. actual dates and the "lap" (time difference). Another report tracks "protocol finalized to first site initiated" at a global level, showing planned, forecast, and actual dates to assess overall study progress.
DVQT Walkthrough
Daelight Solutions
/@daelightsolutions2128
Nov 18, 2022
This video provides an in-depth walkthrough of the Daylight Vault Query Tool (DVQT), an interactive user interface designed to streamline the extraction and analysis of data from Veeva Vault instances. Presented by Mike Mulhearn, the solutions lead at Daylight and creator of DVQT, the tool was initially conceptualized to assist their migration and integration teams in better analyzing Veeva Vault environments, ultimately enhancing their ability to deliver high-quality client solutions. The demonstration highlights DVQT's efficiency, ease of use, and unique capabilities that extend beyond standard VQL (Vault Query Language) functionalities. The core of DVQT's value proposition lies in its ability to overcome common limitations encountered when working with Veeva Vault data. It comes pre-packaged with helpful sample queries and allows users to build and store their own. A standout feature is its capacity to automatically extract all attributes for a given object, a functionality not natively available with VQL alone, making comprehensive data retrieval significantly easier. Furthermore, DVQT is engineered to handle large queries with exceptional efficiency, capable of returning over one million results per minute on a typical laptop, addressing a major pain point often experienced with other tools like Postman due to API limitations. The demo systematically guides the viewer through the tool's interface and functionalities. After a straightforward login process that accommodates both single sign-on and password-based accounts, users are presented with a query window. Mulhearn demonstrates running a "documents query" using a `select *` command, showcasing how DVQT retrieves all attributes for an object and efficiently handles large result sets. The tool then allows for local transformation of the retrieved data using standard SQL commands, enabling further filtering, aggregation (e.g., counting documents per study), and advanced analysis such as duplicate document detection using MD5 checksums. Finally, the processed data can be easily exported into various formats, including Excel, CSV, JSON, and SQLite, facilitating integration with other systems or reporting tools. The video concludes by highlighting additional features like viewing all queryable objects, retrieving object metadata, and exporting pick list values, underscoring DVQT's comprehensive utility for anyone working extensively with Veeva Vault. Key Takeaways: * **Efficient Veeva Vault Data Extraction:** DVQT provides an interactive user interface for quickly extracting and analyzing data from Veeva Vault instances, addressing common challenges faced by migration, integration, and data analysis teams. * **Overcoming VQL Limitations:** The tool offers unique capabilities not available with VQL alone, such as the ability to automatically extract *all* attributes for a given object using a simple `select *` query, significantly simplifying comprehensive data retrieval. * **High Performance for Large Datasets:** DVQT is highly efficient in handling large queries, capable of returning over one million results per minute, which is a substantial improvement over other methods that may be constrained by API limitations (e.g., Postman). * **Local SQL Data Transformation:** Users can perform local data transformations and advanced analysis on retrieved Veeva Vault data using standard SQL commands, allowing for filtering, aggregation, and complex operations directly within the tool. * **Versatile Data Export Options:** Query results can be easily exported into multiple formats, including Excel, CSV, JSON, and SQLite, providing flexibility for further analysis, reporting, or integration with other business intelligence tools. * **Pre-packaged and Custom Query Management:** DVQT comes with pre-packaged sample queries for common use cases and allows users to store their own useful queries, accelerating workflow and promoting best practices. * **Advanced Data Analysis Features:** The demo specifically highlights functionalities like duplicate document detection using MD5 checksums and the ability to aggregate data (e.g., count documents per study), which are critical for data quality and operational insights. * **Comprehensive Veeva Vault Metadata Access:** The tool enables users to view all VQL queryable objects, retrieve detailed metadata for specific objects, and export all pick list values, providing a deeper understanding of the Veeva Vault data model. * **Regulatory Compliance Support:** The ability to view audit trails for documents directly within the tool is crucial for maintaining regulatory compliance and facilitating audit readiness, as it provides a clear record of changes and actions. * **Accessibility and Cost-Effectiveness:** DVQT is available globally and can be requested for free from the Daylight Solutions website, making it an accessible and cost-effective solution for organizations working with Veeva Vault. Tools/Resources Mentioned: * **DVQT (Daylight Vault Query Tool):** The primary tool demonstrated for Veeva Vault data extraction and analysis. * **Veeva Vault:** The enterprise content and data management platform from which DVQT extracts data. * **VQL (Vault Query Language):** Veeva's proprietary query language, enhanced by DVQT's features. * **SQL:** Used for local data transformation and analysis within DVQT. * **Postman:** Mentioned as a comparison point for its limitations in handling large Veeva API query results. * **Export Formats:** Excel, CSV, JSON, SQLite. Key Concepts: * **Veeva Vault:** A cloud-based content and data management platform widely used in the life sciences industry for managing documents, quality processes, clinical operations, and regulatory submissions. * **VQL (Vault Query Language):** A SQL-like language used to query data within Veeva Vault. * **MD5 Checksum:** A cryptographic hash function used to verify data integrity and identify duplicate files based on their content. * **Pick List Values:** Predefined, standardized lists of options for specific fields within Veeva Vault, ensuring data consistency. * **Audit Trail:** A chronological record of events, actions, and changes made within a system or to a document, essential for regulatory compliance and accountability. Examples/Case Studies: * **Documents Query:** Demonstrating how to retrieve all attributes for documents stored in Veeva Vault, including handling large result sets. * **Aggregating Documents per Study:** Using SQL to count the number of documents associated with each study, providing insights into clinical data management. * **Duplicate Document Detection:** Identifying duplicate documents within Veeva Vault by comparing their MD5 checksums, crucial for data quality and storage optimization.
A Fiduciary's Guide to Data Analytics with Agility Innovation Partners
Self-Funded
@SelfFunded
Nov 17, 2022
This video provides an in-depth exploration of how data analytics, particularly in the context of the Consolidated Appropriations Act (CAA), is transforming health plan management for employers and the role of benefits brokers. Brian Behnken, Chief Data and Analytics Officer, and Drew Calistead, Chief Strategy Officer for Agility Innovation Partners, discuss the evolution of healthcare data analysis, the challenges faced by brokers and employers, and the opportunities presented by new regulations and advanced data platforms. They emphasize that the CAA, which mandates transparency in healthcare pricing, has shifted the employer's responsibility from a passive payer to a proactive fiduciary, necessitating the use of sophisticated data tools. The discussion highlights the historical difficulties in accessing and utilizing healthcare claims data, from floppy disks in the 90s to today's complex digital landscape. Agility Innovation Partners addresses two primary challenges for brokers: the high cost of data analytics platforms and the difficulty in effectively using them without specialized staff. Their solution involves offering "at-scale pricing" for their chosen platform, Innovu, to small-to-mid-market brokers, coupled with a "data wingman" service – a dedicated data analyst who consults and assists brokers in maximizing their platform investment. This approach aims to democratize access to powerful analytics, enabling brokers to drive measurable changes to health plans and better serve their self-funded clients. A significant portion of the conversation focuses on the post-CAA landscape, where employers now have access to claims and pricing data, empowering them to benchmark costs and ensure compliance. Innovu's platform integrates a CAA fiduciary tool stack, allowing benchmarking against millions of lives for plan design, claims costs, and fixed costs. Crucially, it also incorporates hospital transparency data, which reveals contracted rates by procedure, hospital, and payer. This unprecedented access to pricing information allows employers to compare what they are paying through traditional networks versus cash prices or alternative arrangements like Reference-Based Pricing (RBP), uncovering substantial opportunities for cost reduction (estimated 20-30%). The speakers present a compelling case for brokers to embrace data as a competitive advantage, transforming their role from merely managing renewals to actively leading clients towards more affordable and transparent healthcare solutions. Key Takeaways: * **CAA's Transformative Impact:** The Consolidated Appropriations Act (CAA) has fundamentally changed healthcare transparency, moving employers from passive payers to proactive fiduciaries responsible for ensuring reasonable health plan costs and compliance. Fines for non-compliance can be substantial ($100/day per employee). * **Low Data Analytics Adoption:** Despite its importance, only about 10% of brokerage consulting firms are "all in" on data analytics platforms, indicating a significant market opportunity for those who embrace it. * **Common Broker Challenges:** Brokers typically face two main hurdles: the high cost of data analytics platforms and the lack of internal expertise or staff to effectively utilize them, often leading to underutilized "shelfware." * **Agility's Solution: At-Scale Pricing & Data Wingman:** Agility Innovation Partners addresses these challenges by offering Innovu, a data analytics platform, at "at-scale pricing" for mid-market brokers (5-15 self-funded cases), making it affordable. They also provide a dedicated data analyst ("wingman") to help brokers leverage the platform effectively, acting as an outsourced, part-time team member. * **Innovu's Fiduciary Tool Stack:** The Innovu platform includes a CAA fiduciary tool stack that enables benchmarking of claims costs, fixed costs, and plan design against a database of over 4 million lives, helping employers determine if they are paying reasonable costs. * **Hospital Transparency Data Integration:** Innovu integrates hospital transparency files, which detail contracted rates by procedure, hospital, and payer. This allows employers to compare what they are paying through their networks to what they "could have paid" under different arrangements (e.g., cash price), exposing significant cost discrepancies. * **Unlocking the "Black Box" of Healthcare:** The combination of CAA regulations and integrated hospital transparency data effectively "unlocks the black box" of healthcare pricing, providing unprecedented visibility into costs and enabling informed decision-making. * **Actionable Cost Reduction Strategies:** With data insights, employers can pivot from traditional networks to alternative arrangements like narrow networks, direct contracting, or Reference-Based Pricing (RBP) to reduce costs. RBP, for instance, is seen as a stepping stone, potentially 10-15% above cash/Medicare prices, but still significantly below traditional commercial rates. * **Significant Savings Potential:** The speakers suggest that leveraging these data insights could lead to 20-30% cost reductions in healthcare spend, a dramatic shift from the typical 5-10% adjustments seen with traditional population health initiatives. * **Proactive vs. Passive Purchasing:** Data empowers plan sponsors to transition from being "passive payers" to "proactive purchasers," making informed decisions about healthcare services based on transparent pricing and value. * **Competitive Advantage for Brokers:** Brokers who proactively embrace data analytics can transform their marketing strategy, win new business by demonstrating tangible value and savings opportunities, and significantly improve client retention. * **Long-Term Strategic Decision:** Investing in a data analytics platform is a long-term, lifestyle change for a firm, not a cyclical or reactionary measure. It requires a commitment to becoming a data-driven organization. * **Getting Started:** The process of onboarding data onto a platform typically takes about three months. Brokers are encouraged to start educating themselves and their clients on CAA and data now, even during Q4, to be ready for January 1. **Tools/Resources Mentioned:** * **Innovu:** The specific data analytics platform partnered with by Agility Innovation Partners. * **CAA Fiduciary Tool Stack:** A feature within Innovu for benchmarking and compliance. * **Hospital Transparency Data:** Publicly available files from hospitals, integrated into Innovu, detailing contracted rates. **Key Concepts:** * **Consolidated Appropriations Act (CAA):** Federal legislation establishing protections for consumers related to surprise billing and transparency in health care, imposing fiduciary responsibilities on employers. * **Fiduciary Responsibility:** The legal and ethical obligation of employers to act in the best financial interest of their health plan participants, now requiring due diligence on health plan costs and services. * **At-Scale Pricing:** Offering a premium service or platform at a reduced price point by leveraging collective buying power, making it accessible to smaller entities. * **Data Wingman:** A dedicated data analyst provided as a service to assist brokers in utilizing a data analytics platform, effectively acting as an expert consultant. * **Hospital Transparency Data:** Mandated public disclosure of contracted rates by procedure, hospital, and payer, providing unprecedented insight into healthcare pricing. * **Reference-Based Pricing (RBP):** A healthcare payment model where providers are paid a set amount based on a reference price (often Medicare rates plus a percentage), rather than negotiated rates with traditional networks.
Deviations in Pharmaceutical industry l Interview Questions
PharmGrow
/@PharmGrow
Nov 15, 2022
This video provides a comprehensive overview of deviations within the pharmaceutical industry, framed as a series of interview questions and answers. It covers the fundamental definition, classification, and regulatory importance of deviations, alongside detailed discussions on their investigation, impact assessment, and management within a Quality Management System (QMS). The speaker emphasizes the structured approach required for handling deviations, from initial identification and reporting to root cause analysis, corrective and preventive actions (CAPA), and closure, highlighting the critical role deviations play in ensuring product quality and regulatory compliance. Key Takeaways: * **Foundational Role in QMS & Compliance:** Deviations are defined as departures from established procedures and are a core component of pharmaceutical QMS, directly impacting regulatory compliance (e.g., ICH Q10, GxP). Proper handling is a regulatory expectation. * **Structured Investigation & Impact Assessment:** The process involves classifying deviations (minor, major, critical), forming cross-functional teams (CFTs) for investigation, utilizing various tools (e.g., 5 Why, Fishbone, FMEA), and performing comprehensive impact assessments on existing, previous, and future batches. * **Timeliness and Root Cause Focus:** Prompt reporting (within 24 hours) and adherence to defined closure timelines are crucial for effective deviation management. The primary goal is to identify the root cause (or most probable cause) to prevent recurrence, with human error being a frequently cited factor. * **QMS Software Integration:** The video explicitly mentions specialized software like TrackWise as commonly used for deviation handling, indicating the industry's reliance on dedicated systems for managing these critical processes. This highlights an opportunity for AI-powered enhancements or custom integrations. * **Procedural Rigor and Data Integrity:** The discussion underscores the need for clear procedures for various scenarios, such as distinguishing deviations from incidents, avoiding "planned deviations" in favor of change controls, and the importance of not covering multiple discrepancies in a single deviation. The deviation count serves as an indicator of the overall health and control of a facility's QMS.
Adult ADHD Impact on Health
AHealthcareZ - Healthcare Finance Explained
@ahealthcarez
Nov 13, 2022
This video, presented by Dr. Eric Bricker of AHealthcareZ, provides an in-depth analysis of adult Attention Deficit Hyperactivity Disorder (ADHD) and its profound, yet often hidden, impact on individual health and employee health plans. Dr. Bricker aims to shed light on ADHD as a significant public health issue, moving beyond the common misconception that it is solely a childhood condition. He emphasizes that ADHD is a genetic disorder characterized by decreased self-regulation, inattention, impulsivity, and low conscientiousness, which collectively lead to poor judgment and an inability to connect known consequences with behavioral change. The discussion highlights the stark reality that a large majority of children with ADHD continue to experience the condition into adulthood, with a two-to-one prevalence of men over women. A central theme of the presentation is the severe health consequences associated with untreated adult ADHD. Dr. Bricker cites compelling statistics, noting that adults with ADHD have a decreased life expectancy of 12.7 years—a reduction more than three times greater than that caused by smoking or alcohol abuse. He attributes this alarming figure to a cascade of unhealthy behaviors and increased risks: individuals with ADHD are two to three times more likely to be obese, face a three times higher risk of developing type 2 diabetes, and have a 30-40% increased risk of heart disease. These individuals often engage in poor dietary habits (high fat, sugar, carbohydrates), have a higher incidence of accidents (especially motor vehicle accidents), and exhibit greater rates of smoking and alcohol abuse. The speaker contrasts these behaviors with five identified healthy behaviors (not smoking, daily exercise, BMI < 25, no excess alcohol, healthy diet) that can increase life expectancy by 12-14 years, underscoring that people with ADHD tend to do the exact opposite. Despite the severe health implications, Dr. Bricker offers a critical solution: ADHD is highly diagnosable and treatable. Diagnosis typically occurs through a psychiatrist, psychologist, or primary care physician using criteria from the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition). The primary and most effective treatment involves stimulant medications such as Ritalin and Dex-Amphetamine, often combined with cognitive behavioral therapy. However, a significant public health gap exists, as only 20% of adults with ADHD are diagnosed and treated, leaving four out of five individuals without necessary intervention. Dr. Bricker concludes by presenting a compelling opportunity for employee health plans: given that a small percentage of plan members drive a disproportionately large share of healthcare costs, it is highly probable that many high-cost claimants have undiagnosed and untreated ADHD. Identifying and treating these individuals through outpatient settings like on-site clinics, near-site clinics, or direct primary care represents a substantial, yet largely untapped, opportunity to improve population health and reduce overall healthcare expenditures. Key Takeaways: * **Prevalence and Persistence of Adult ADHD:** ADHD is not just a childhood disorder; 2-5% of adults are affected, and the majority of children with ADHD continue to experience symptoms into adulthood, with a 2:1 male-to-female ratio. * **Core Nature of ADHD:** It is a genetic condition primarily characterized by decreased self-regulation, impulsivity, inattention, and low conscientiousness, leading to an inability to connect known consequences with behavioral change. * **Profound Impact on Life Expectancy:** Adult ADHD significantly reduces life expectancy by 12.7 years, which is over three times the reduction caused by smoking or alcohol abuse, highlighting its severe public health burden. * **Increased Health Risks:** Individuals with ADHD face substantially higher risks for obesity (2-3x), type 2 diabetes (3x), heart disease (30-40% increase), motor vehicle accidents, and substance abuse (smoking, alcohol). * **Counter-Productive Behaviors:** The impulsivity and poor judgment associated with ADHD lead individuals to consistently engage in behaviors opposite to those proven to promote health and longevity, such as poor diet, lack of exercise, and substance abuse. * **Diagnosable and Treatable Condition:** ADHD can be effectively diagnosed using criteria from the DSM-5 by mental health professionals or primary care physicians. * **Effective Treatment Modalities:** The mainstay of treatment involves stimulant medications (e.g., Ritalin, Dex-Amphetamine), often complemented by cognitive behavioral therapy (CBT), which can significantly improve outcomes. * **Significant Treatment Gap:** A major challenge is that only 20% of adults with ADHD are diagnosed and treated, leaving 80% without intervention, perpetuating negative health outcomes. * **Opportunity for Employee Health Plans:** Undiagnosed and untreated ADHD likely contributes significantly to the high healthcare costs associated with the top 5% of claimants in employer-sponsored health plans. * **Strategic Intervention for Cost Reduction and Health Improvement:** Identifying and treating adult ADHD through outpatient settings like on-site clinics, near-site clinics, or direct primary care offers a substantial opportunity to improve the health of plan members and reduce overall healthcare expenditures. * **Focus on Outpatient Care:** Diagnosis and initiation of ADHD treatment are typically done in outpatient primary care or psychiatric settings, not during hospitalizations for acute conditions. Tools/Resources Mentioned: * **DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition):** The standard diagnostic tool used by mental health professionals and physicians to diagnose ADHD. * **Ritalin (Methylphenidate):** A common stimulant medication used to treat ADHD. * **Dex-Amphetamine (Dextroamphetamine):** Another common stimulant medication used in ADHD treatment. * **Cognitive Behavioral Therapy (CBT):** A therapeutic approach often used in conjunction with medication for ADHD treatment. Key Concepts: * **Self-Regulation:** The ability to manage one's thoughts, emotions, and behaviors, which is impaired in individuals with ADHD. * **Conscientiousness:** A personality trait characterized by being careful, diligent, and wishing to do one's work well; often low in individuals with ADHD, leading to a disregard for consequences. * **5/50 Rule in Employee Health Plans:** The observation that approximately 5% of an employee health plan's members account for 50% of the total healthcare costs, highlighting areas for targeted intervention.
Labeling - Change Requesting a label
Envu's Guide Through Veeva Vault
/@envusguidethroughveevavaul5558
Nov 8, 2022
This video provides a practical, step-by-step guide on managing a label change request within Veeva Vault, specifically when a competent authority, such as the EPA, requests modifications to an already submitted label. The core purpose is to demonstrate the workflow for documenting, implementing, and resubmitting these changes while maintaining document integrity and an auditable trail within the Veeva system. The presenter walks through the entire process, from marking the original label as "change requested" to preparing the revised label for resubmission, emphasizing Veeva's functionalities for version control, document renditions, and attachment management. The demonstration begins with an existing label in a "submitted" state, which the EPA has now requested changes for. The initial step involves updating the status of the original label to "change requested" to accurately reflect its current standing. A critical part of the process is creating a draft of the original document, which ensures that the integrity of the previously submitted version is preserved while allowing for edits on a new, versioned copy (e.g., moving from version 1.0 to 1.1). The video then details the editing process, highlighting the importance of using "track changes" to clearly document all modifications made in response to the authority's request. Further into the guide, the presenter explains how to leverage Veeva's capabilities for document check-in/check-out, which, in a production environment, integrates seamlessly with Microsoft Word for direct editing. A key feature demonstrated is the "word rendition setting," which allows users to generate both "clean" (no markups) and "shaded" (with track changes visible) versions of the label – both essential for regulatory submissions. The video also covers the "direct release" option for the revised label, contrasting it with a more extensive review workflow. Finally, it illustrates how to attach the EPA's original change request PDF directly to the label within Veeva, linking the request to the specific label version for future reference and auditability, before preparing the final, revised label for resubmission. Key Takeaways: * **Accurate Status Tracking:** It is crucial to mark the original label as "change requested" within Veeva once a competent authority has requested modifications, ensuring the system accurately reflects the document's current regulatory status. * **Preserving Document Integrity with Drafts:** Always create a new draft of a submitted document (e.g., version 1.1 from 1.0) when changes are required. This preserves the integrity of the previously submitted version while allowing for documented edits on the new draft. * **Leveraging Veeva's Versioning:** Veeva automatically manages document versioning (e.g., 1.0 to 1.1), providing a clear audit trail and the ability to revert to previous steady states if needed. This system-level versioning can potentially reduce the reliance on manual date stamping within the document itself. * **Documenting Changes with Track Changes:** Utilize the "track changes" feature during the editing process to clearly highlight all modifications made to the label. This is vital for transparency and regulatory compliance, as authorities often require visibility into all changes. * **Seamless Editing in Production:** In a full production environment, Veeva integrates directly with Microsoft Word, allowing for in-system editing without the need to download and re-upload documents, streamlining the check-out/check-in process. * **Generating Clean and Shaded Renditions:** Veeva's "word rendition setting" is a powerful feature that allows users to generate both "clean" (final) and "shaded" (with track changes) versions of the label. Both renditions are typically required for submission back to regulatory authorities. * **Automating Rendition Uploads:** An upcoming enhancement will automatically upload both clean and shaded versions into the rendition section, further simplifying the preparation of submission packages. * **Workflow Flexibility:** Veeva offers workflow options such as "direct release" for immediate finalization or a more extensive "editing or review" process, depending on internal company policies and the nature of the changes. * **Attaching External Regulatory Correspondence:** It is a best practice to attach the competent authority's change request (e.g., EPA's PDF) directly to the corresponding label version within Veeva. This links the request to the specific document, providing context and an auditable record for future inquiries. * **Clear Naming Conventions for Submissions:** When preparing for resubmission, it is recommended to include the regulatory action in the document title (e.g., "r0102 - EPA Change Request") to easily identify and search for specific documents, especially when managing multiple versions. * **Tracking Document States:** Veeva clearly indicates the state of a document (e.g., Draft, Steady State, Submitted, Plan), providing a comprehensive overview of its lifecycle and readiness for various actions. * **Regulatory Compliance Focus:** The entire workflow demonstrated is designed to ensure that label changes are managed in a compliant manner, providing the necessary documentation and traceability required by regulatory bodies like the EPA. Tools/Resources Mentioned: * **Veeva Vault:** The primary platform used for managing the label change request process. * **Microsoft Word:** The document editor used for making changes to the label, with seamless integration in Veeva's production environment. Key Concepts: * **Change Request:** A formal request from a regulatory authority (e.g., EPA) to modify an already submitted document, such as a product label. * **Competent Authority:** The regulatory body responsible for overseeing and approving product labels and other submissions (e.g., EPA in the U.S.). * **Labeling:** The process and content of product labels, which are subject to strict regulatory guidelines in industries like pharmaceuticals and life sciences. * **Versioning:** The system of tracking and managing different iterations of a document, typically denoted by numbers (e.g., 1.0, 1.1, 2.0), ensuring a historical record of all changes. * **Draft State:** A document status indicating that it is under active revision and not yet finalized or in a "steady state." * **Steady State:** A document status indicating that it is a finalized, approved, and stable version, often representing a submitted or released document. * **Word Rendition Setting:** A Veeva feature that allows the generation of different visual representations of a Word document, specifically "clean" (final version without markups) and "shaded" (version with track changes visible). * **Direct Release:** A workflow option in Veeva that allows a document to be immediately finalized and released without requiring additional review steps. * **Regulatory Action:** The specific type of submission or interaction with a regulatory authority (e.g., initial submission, change request, amendment). Examples/Case Studies: * **Natalie's Wonder Product:** A fictional product used as an example for the label change process, including an alternate brand name "Natalie's Wonder Product 2.0." * **EPA (Environmental Protection Agency):** Cited as the "competent authority" requesting changes to the label, illustrating a real-world regulatory body interaction.
Important Elements From An Investigative Site File Regulatory Binder For A Clinical Research Monitor
Dan Sfera
/@dansfera
Nov 7, 2022
This video provides a detailed overview of the essential elements within an Investigator Site File (ISF), also known as a regulatory binder, from the perspective of a clinical research monitor. The speaker outlines critical documents and logs that monitors scrutinize during site visits to ensure regulatory compliance and proper study conduct within clinical trials. Key areas of focus include protocol adherence, staff training and delegation, informed consent management, investigational product (IP) accountability, protocol deviation tracking, and oversight by Institutional Review Boards (IRBs) and for Serious Adverse Events (SAEs). The discussion emphasizes the practical, pragmatic approach monitors take to ensure sites maintain comprehensive and up-to-date documentation, highlighting the continuous nature of compliance checks. Key Takeaways: * **Criticality of Investigator Site File (ISF) Management:** The ISF (regulatory binder) is central to clinical trial compliance, requiring meticulous management of documents such as protocols, delegation logs, staff training records, informed consents, and investigational product (IP) accountability logs. * **Monitor's Role in Ensuring Regulatory Adherence:** Clinical Research Monitors (CRAs) focus on verifying key elements like PI signatures on protocol amendments, current staff training and delegation, proper IP storage and dispensing (including temperature logs), and timely IRB continuing reviews to ensure ongoing compliance. * **Proactive and Continuous Monitoring:** The video emphasizes that critical aspects like IP accountability and informed consent amendments require continuous, proactive monitoring throughout the study lifecycle, rather than being deferred to closeout, to maintain data integrity and patient safety. * **Interconnectedness of Compliance Documentation:** Many regulatory documents are interdependent; for example, protocol deviations necessitate documented training, highlighting the complexity of maintaining a fully compliant and auditable ISF. * **Implications for AI and Data Solutions:** The detailed, log-intensive, and highly structured nature of ISF management and monitoring, as described, presents a clear opportunity for AI-powered solutions to enhance compliance tracking, automate audit trails, and streamline data integrity checks
Veeva Vault 22R2 Release Questions and Answers || Veeva 22R2 New Release Features || Veeva Vault Que
The Corporate Guys
/@TheCorporateGuys
Nov 5, 2022
This video provides an in-depth overview of the new features introduced in the Veeva Vault 22R2 release, primarily aimed at administrators and users preparing for the associated certification exam. The speaker, Vaibhav Agrawal, details three significant enhancements: improved configuration migration with "Outbound Package View and Add Dependencies," streamlined content discovery through "Add Documents to Expanded Search" (Search Collections), and advanced reporting capabilities by supporting "Document Roles as a Reporting Object." The discussion also covers the exam structure, passing criteria, and important considerations for each new feature. Key Takeaways: * **Enhanced Configuration Migration:** The "Outbound Package View and Add Dependencies" feature allows administrators to proactively identify and include missing dependent components (e.g., picklist values, document fields) when migrating configurations between Veeva Vault environments (e.g., sandbox to production). This significantly reduces deployment errors by ensuring all necessary components are moved together, with a maximum display of 2000 dependent components. * **Consolidated Content Search:** "Search Collections" enable users to group up to 15 objects and a single document type into a unified collection, facilitating a single-point search for related records and documents. This eliminates the need to navigate multiple tabs, improving efficiency in content discovery, provided the "Allow Expanded Search" option is enabled during collection creation. * **Advanced Document Role Reporting:** The introduction of "Document Role" and "Document with Document Role" as new report types empowers administrators to generate detailed reports on user roles and group assignments across documents. This allows for analysis of active/inactive users with specific document permissions (e.g., owners, reviewers), and when "Document" is the primary object, "Users and Groups" can also be selected as related reporting objects. * **Veeva 22R2 Exam Preparation:** The video outlines the critical aspects of the Veeva Vault 22R2 certification exam, including a deadline of December 16th, a passing score of 80% (8 out of 10 questions), and specific policies for retakes based on initial performance. * **Practical Implementation Details:** For each feature, the speaker provides practical details such as navigation paths (e.g., Admin > Settings > Search Collections), specific checkboxes to enable functionality, and limitations (e.g., only one document type per search collection, maximum three related objects for relationships).
Episode 5: How Will RTSM Impact Clinical Data?
Veeva Systems Inc
/@VeevaSystems
Nov 3, 2022
This video provides an in-depth exploration of the evolution and future impact of Randomization and Trial Supply Management (RTSM) on clinical data, featuring Natalie Townsend, VP, Strategy, Veeva RTSM, and Richard Young, VP, Strategy, Veeva Vault CDMS. The discussion traces the journey of digital clinical trials from their early, often cumbersome, phone-based and spreadsheet-centric beginnings to the sophisticated, cloud-based solutions prevalent today. A central theme is the critical interplay between RTSM and Electronic Data Capture (EDC) systems, examining how data management, site supplies, and randomization can harmoniously integrate to overcome long-standing challenges in clinical trial operations. The conversation highlights the persistent issues within the RTSM space, such as managing complexity and ensuring timely, accurate data flow, despite significant technological advancements. Townsend points out that many current processes are still influenced by past Corrective and Preventive Actions (CAPAs) from 10-15 years ago, even when modern tools could offer more efficient solutions. This leads to the concept of moving from "anxiety of change" to "confidence in success," urging the industry to re-evaluate legacy practices and embrace new technologies to anticipate future needs rather than being inhibited by past failures. The speakers emphasize the need for open architecture and intelligent, connected workflows that allow both RTSM and EDC systems to operate optimally without compromising each other's design requirements. Furthermore, the video delves into the strategic considerations for integrating these systems, advocating for a flexible approach rather than a mandated one-way data flow. It suggests that RTSM should ideally handle only the minimal data necessary for randomization and trial supply, keeping processes lean and efficient. The dialogue also touches upon the broader tension between scientific rigor and operational excellence in trial design, likening it to solving a complex Rubik's Cube. The ultimate goal is to bridge existing silos between data managers and supply managers, fostering a unified approach that ensures technology supports, rather than hinders, scientific advancement and operational agility, especially in the face of unforeseen circumstances like a pandemic. The discussion concludes with a vision for truly digital communication workflows, enhanced compliance reporting, and the elimination of outdated practices like paper CRFs and batch edit checks in favor of real-time, intelligent monitoring. Key Takeaways: * **Evolution of Clinical Data Management:** Clinical trials have progressed from rudimentary phone-based and spreadsheet systems to sophisticated web and cloud-based solutions, significantly improving data entry and management processes. * **Persistent Challenges in RTSM:** Despite technological advancements, the RTSM space still grapples with challenges related to handling complexity, ensuring data is in the right place at the right time, and seamless integration with other clinical systems. * **Re-evaluating Legacy Processes:** Many current operational practices are rooted in past CAPAs or decisions made years ago, which may no longer be optimal with modern toolsets. There's a critical need to revisit and modernize these processes. * **Embracing Change with Confidence:** The industry should shift from an "anxiety of change" mindset, which anticipates failure, to a "confidence in success" approach, leveraging new technologies to drive efficiency and innovation. * **Seamless RTSM-EDC Integration:** The goal is to achieve better connected workflows between RTSM and EDC systems, allowing each system to maintain its optimal design without being compromised by integration requirements, moving beyond simple data auto-population. * **Open Architecture for Flexibility:** Systems should be built with open architecture to support flexible, bidirectional data flow, acknowledging that the starting point for data integration (e.g., EDC to RTSM or vice versa) can vary based on protocol design. * **Minimalist RTSM Data Strategy:** RTSM systems should ideally focus on handling only the minimal data required for randomization and trial supply, ensuring lean processes and reducing complexity for data managers. * **Balancing Scientific and Operational Excellence:** Clinical trial design involves a delicate balance between scientific rigor and operational efficiency. Technology should enable both to move in lockstep, rather than creating tension or holding back scientific progress. * **Bridging Silos in Clinical Operations:** There is a need to unify the perspectives and solutions for data managers and supply managers to prevent fragmented approaches and ensure a holistic view of trial operations. * **Agile and Adaptable Technology:** To cope with rapidly changing scientific needs and unforeseen global events (e.g., pandemics), clinical trial applications must be agile and capable of quick adaptation, avoiding monolithic systems that are difficult to pivot. * **Standardization for Clarity:** Establishing RTSM standards, similar to CRF libraries in EDC, and aligning on terminology (e.g., "transaction dates" vs. "event dates") is crucial to prevent confusion, reconciliation issues, and improve overall data quality. * **Truly Digital Communication Workflows:** A future vision includes entirely digital and seamless communication workflows for resolving data changes, queries, and deviations, eliminating reliance on paper, emails, and manual interventions. * **Enhanced Compliance Reporting:** The industry should better utilize existing data from RTSM (drug accountability), EDC (visit dates), and ePRO/devices to generate more comprehensive and insightful compliance reports, moving beyond basic data cleaning. * **Elimination of Outdated Practices:** Practices like paper CRFs, scanning/signing paper forms, and batch edit checks should be relegated to the past. Modern systems should provide real-time alerting and intelligent monitoring of data discrepancies. Tools/Resources Mentioned: * Veeva RTSM (Randomization and Trial Supply Management) * Veeva EDC (Electronic Data Capture) * Veeva Vault CDMS (Clinical Data Management System) * ePRO (Electronic Patient Reported Outcomes) * IVR (Interactive Voice Response) Key Concepts: * **RTSM (Randomization and Trial Supply Management):** Technology used in clinical trials to manage patient randomization into study arms and the supply of investigational products. * **IRT (Interactive Response Technology):** An older, broader term encompassing IVR and IWR (Interactive Web Response), often used interchangeably with RTSM in the past. * **EDC (Electronic Data Capture):** Software used to collect clinical trial data from sites in an electronic format. * **ePRO (Electronic Patient Reported Outcomes):** Electronic systems for patients to directly report their health status and experiences. * **CAPA (Corrective and Preventive Action):** A system for identifying, documenting, and resolving non-conformances and preventing their recurrence, often impacting operational processes. * **CRF (Case Report Form):** A document, electronic or paper, designed to record all protocol-required information on each trial participant. * **Open Architecture:** System design that allows for easy integration and interoperability with other systems and platforms. Examples/Case Studies: * **Adaptive Trials:** Discussion of planned mid-study amendments for adaptive trials, including new cohorts, doses, and visit schedules, highlighting the need for flexible systems. * **Extensive Screening Processes:** An example where a very extensive screening process with numerous calculations and data points naturally sits better within the CRF before integrating with RTSM, illustrating the need for protocol-specific data flow decisions.
CaseStudy Veeva ThreatStack F5 Cloud Security Threat Detection
AIP F5 Brand
/@aipf5Brand
Nov 2, 2022
This video provides an in-depth exploration of how Veeva Systems, a leading software provider for the life sciences community, addresses its cloud security, visibility, and compliance requirements through the adoption of F5/Threat Stack solutions. Featuring Russell Shupert, Senior Director of Security Engineering at Veeva Systems, the discussion highlights the unique challenges of securing cloud environments, particularly for early adopters in highly regulated industries. The webinar serves as a practical case study, detailing Veeva's journey from confronting initial cloud security hurdles to implementing a sophisticated threat detection and compliance system that significantly enhances operational efficiency and incident response capabilities. The core of the discussion revolves around the evolution of cloud security and Veeva's strategic decision-making process. Shupert explains that early cloud adopters like Veeva struggled with adapting traditional data center security tools to a cloud-native landscape, necessitating either homegrown solutions or the careful evaluation of emerging cloud security vendors. A pivotal moment, influenced by global incidents like the SolarWinds hack, led Veeva to re-evaluate its trust in third-party security providers and prioritize tools that operate with a low-privileged access model. This critical requirement, combined with the need for actionable, high-fidelity data, ultimately guided their selection of Threat Stack. Shupert elaborates on the tangible benefits realized from the Threat Stack implementation, emphasizing its seamless integration with major cloud providers like Amazon CloudTrail and Azure. A key differentiator for Veeva was Threat Stack's ability to correlate vast amounts of data, drastically reducing false positives from over 90% to under 20%, thereby transforming their security operations. The system provides comprehensive, contextualized information for incident response, allowing Veeva to quickly understand the blast radius of a threat and its position within the MITRE kill chain. Looking ahead, Veeva's strategy includes minimizing the number of security vendors to reduce complexity and centralize information, a goal further supported by F5's acquisition of Threat Stack, which is seen as a natural fit for expanding cloud security offerings. Key Takeaways: * **Veeva Systems' Industry Focus:** Veeva Systems specializes in building software for the highly regulated life sciences community, including pharmaceutical, biotech, consumer health, and med tech sectors, underscoring the critical importance of robust security and compliance in their operations. * **Evolution of Cloud Security:** Early cloud adopters like Veeva faced significant challenges in securing their environments due to the lack of cloud-specific security tools, often relying on adapted traditional methods or developing in-house solutions. However, cloud security offerings have matured significantly, now providing capabilities comparable to traditional data center security. * **Observability as a Core Challenge:** Achieving comprehensive observability in complex cloud environments is a magnified challenge compared to traditional data centers, requiring specialized tools and strategies to gain visibility into distributed systems. * **Impact of Supply Chain Security Incidents:** Global events, such as the SolarWinds incident, prompted Veeva to critically re-evaluate its trust in third-party security vendors and prioritize solutions with stringent security models, particularly those operating with low-privileged access. * **Preference for Low-Privileged Security Tools:** A key selection criterion for Veeva was the requirement for security tools that do not operate with default privileged or administrative access, preferring elevation only when explicitly commanded. Threat Stack was unique in offering this capability at the time of Veeva's adoption. * **Actionable Intelligence Over Noise:** Veeva prioritized security solutions that deliver reliable, actionable data with a significantly low false positive rate. Threat Stack reduced their false positive rate from over 90% to under 20%, allowing security teams to focus on genuine threats rather than chasing irrelevant alerts. * **Comprehensive Incident Response Capabilities:** Threat Stack provides all necessary correlated data at the security engineer's fingertips, detailing both external and internal impacts of a threat. This enables rapid assessment of the blast radius and precise positioning within the MITRE kill chain, facilitating quicker and more effective incident mitigation. * **Quantifiable Operational Efficiency Gains:** By drastically reducing false positives, Veeva's security operations team reclaimed approximately 85% of their time previously spent on alert investigation. This freed up resources to focus on proactive security measures, tool maturation, and strategic tuning. * **Seamless Cloud Provider Integration:** Threat Stack offers native, seamless integration with major cloud providers such as Amazon (specifically CloudTrail) and Azure, ensuring immediate data flow and simplifying deployment across complex, multi-account cloud infrastructures. * **Scalability and Rapid Deployment:** Despite Veeva's highly complex cloud deployment model, encompassing hundreds of Amazon accounts and 31 core product teams, Threat Stack was implemented efficiently. Initial configuration took less than four hours, and full agent rollout across all environments (Dev, test, production, QA) was completed within months. * **Strategic Vendor Consolidation:** Veeva's long-term security objective includes minimizing the number of security vendors to reduce operational complexity, improve system integration, and centralize information for faster threat response. * **F5 Acquisition as a Strategic Enabler:** F5's acquisition of Threat Stack is viewed positively by Veeva, aligning with their vendor consolidation strategy and enhancing F5's overall cloud security offerings, allowing Veeva to potentially leverage a single, trusted vendor for a broader range of security needs. **Tools/Resources Mentioned:** * Threat Stack (now part of F5) * F5 * Amazon (AWS) * Amazon CloudTrail * Azure * SolarWinds (mentioned as a cautionary example of a third-party supply chain incident) **Key Concepts:** * **Observability:** The ability to understand the internal state of a system based on its external outputs. In cloud environments, this involves comprehensive monitoring of logs, metrics, and traces across distributed services to detect anomalies and threats. * **DevSecOps:** An approach that integrates security practices into every phase of the software development lifecycle, emphasizing automation, collaboration, and continuous security monitoring. * **Offensive Security:** Proactive security testing techniques, such as internal and external penetration testing and bug bounty programs, designed to identify vulnerabilities before malicious actors can exploit them. * **Low-Privileged Model:** A security principle where applications or processes operate with the minimum necessary permissions required to perform their functions, significantly reducing the potential impact of a security breach. * **False Positive Rate:** The proportion of security alerts that are incorrectly identified as threats. A high false positive rate leads to "alert fatigue" and wastes security team resources. * **Blast Radius:** The extent of potential damage or impact that a security incident could have on an organization's systems, data, or operations. * **MITRE ATT&CK Kill Chain:** A globally accessible knowledge base of adversary tactics and techniques based on real-world observations. It provides a framework for understanding the stages of an attack and developing defensive strategies. * **Vendor Consolidation:** A strategic initiative to reduce the number of technology vendors an organization uses, aiming to simplify management, improve integration, reduce costs, and streamline support. **Examples/Case Studies:** * **Veeva Systems' Cloud Security Journey:** The entire discussion serves as a case study of Veeva's transition to a cloud-first architecture, the inherent security challenges faced as an early adopter, and their methodical approach to evaluating and implementing a cloud-native security solution. * **SolarWinds Incident:** This real-world supply chain attack was cited as a significant catalyst that prompted Veeva to re-evaluate its trust models for third-party security tools and prioritize solutions with specific operational characteristics, such as low-privileged access. * **Threat Stack's Impact on Veeva's Security Operations Center (SOC):** A concrete example of success was the dramatic reduction in false positive rates from over 90% to under 20%, directly leading to an 85% time savings for Veeva's security operations team, allowing them to shift focus from reactive alert chasing to proactive security enhancements.
Hospital - Insurance Contracting Part 1: Case Rates and Per Diems Explained
AHealthcareZ - Healthcare Finance Explained
@ahealthcarez
Oct 29, 2022
This video provides an in-depth exploration of hospital-insurance contracting, specifically focusing on the methodologies of case rates and per diems. Dr. Eric Bricker, the presenter, begins by establishing the context of how hospital systems and health insurance carriers negotiate prices for various medical services. The presentation aims to demystify these contractual terms, which are fundamental to understanding healthcare finance and the true cost of medical care. The core of the discussion revolves around two primary contracting methodologies: case rates and per diems. Case rates are explained as fixed payments for specific services or procedures, often applied to outpatient imaging like MRIs, CT scans, or mammograms, and certain surgeries. Per diems, on the other hand, represent a fixed payment per day of hospitalization, typically used for inpatient medical stays such as pneumonia or acute renal failure. Dr. Bricker emphasizes that in both scenarios, the hospital's initial "bill charges" become largely irrelevant once a contract is in place; what truly matters is the "allowed amount" that has been negotiated. Through illustrative examples comparing two hypothetical hospitals with different bill charges and negotiated rates for an MRI, the video highlights a critical insight: the perceived "discount" from a hospital's bill charges is a misleading metric. Instead, the actual "allowed amount" is the true indicator of cost-effectiveness. The discussion then extends to the complex negotiation process itself, revealing that insurance carriers typically lead these negotiations, which can be an extensive 18-month process for contracts lasting three to five years. A significant point of contention and a major driver of healthcare cost inflation, according to Dr. Bricker, is the inclusion of "Evergreen inflators"—pre-agreed annual percentage increases (e.g., 6-8%) in reimbursement rates that hospitals secure, even when overall inflation is low. This mechanism, he argues, has historically caused healthcare cost inflation to outpace general inflation by two to three times. The video concludes by clarifying that these specific commercial contracting methods primarily apply to employer-sponsored plans and not to Medicare Advantage, where rates are more closely tied to Medicare. Key Takeaways: * **Case Rates Defined:** A case rate is a fixed, pre-negotiated payment for a specific medical service or procedure, regardless of the hospital's initial bill charges. This methodology is commonly applied to outpatient services like MRI scans, CT scans, mammograms, and certain surgical procedures. * **Per Diems Defined:** A per diem is a fixed, pre-negotiated payment for each day a patient is hospitalized, typically used for inpatient medical stays such as treatment for pneumonia or acute renal failure. Like case rates, it supersedes the hospital's daily bill charges. * **Irrelevance of Bill Charges:** The hospital's initial "bill charges" or list prices are largely irrelevant in the context of negotiated contracts between hospitals and insurance carriers. The actual amount paid is the "allowed amount," which is the negotiated case rate or per diem. * **Focus on Allowed Amount, Not Discount:** When evaluating the value of an insurance contract with a hospital system, the critical metric is the "allowed amount" (the actual payment), not the "discount" or "savings" relative to the hospital's inflated bill charges. A higher discount from a higher bill charge can still result in a higher allowed amount. * **Hospital Price Transparency:** Hospitals are legally mandated to post their prices, and these posted prices should ideally reflect the "allowed amounts" or negotiated rates, offering greater transparency to consumers and self-funded plans. * **Insurance Carriers Lead Negotiations:** The negotiation of these contracts is primarily led by health insurance carriers or insurance networks (e.g., United Healthcare's head of contracting) on behalf of employer-sponsored plans. * **Protracted Negotiation Process:** Hospital-insurance contracts are typically negotiated over a lengthy period, often taking around 18 months to finalize, and are designed to last for three to five years to avoid frequent renegotiations. * **Evergreen Inflators Drive Costs:** A significant factor contributing to healthcare cost inflation is the inclusion of "Evergreen inflators" in these long-term contracts. These are pre-agreed annual percentage increases (e.g., 6-8%) in reimbursement rates that hospitals secure, irrespective of broader economic inflation. * **Healthcare Inflation vs. General Inflation:** Due to these contractual inflators, healthcare cost inflation has historically been two to three times higher than overall general inflation, even during periods of low CPI. * **Commercial vs. Medicare Advantage Distinction:** The contracting methodologies discussed (case rates and per diems with significant inflators) primarily apply to employer-sponsored commercial health plans. Medicare Advantage plans typically have contracted rates that are much closer to, or a small percentage above or below, standard Medicare rates. * **Value for Self-Funded Employers:** Self-funded employer groups should actively analyze their claims data to understand the "allowed amounts" paid to different hospitals, as this data can inform strategies for directing employees to more cost-effective providers. Key Concepts: * **Case Rate:** A fixed payment for a specific medical service or procedure. * **Per Diem:** A fixed payment per day of hospitalization. * **Allowed Amount:** The negotiated rate that an insurance carrier will pay for a service, regardless of the hospital's initial bill charges. * **Bill Charges:** The initial, often inflated, price a hospital lists for a service before any insurance negotiations or discounts. * **Evergreen Inflators:** Pre-determined annual percentage increases built into long-term hospital-insurance contracts, leading to automatic increases in reimbursement rates. * **Self-Funded Plan:** An employer-sponsored health plan where the employer directly assumes the financial risk for providing healthcare benefits to its employees, rather than purchasing a fully insured plan from an insurance carrier. * **Medicare Advantage:** Private health insurance plans that contract with Medicare to provide Medicare benefits, often with different cost structures than traditional commercial plans.
TMF Entry Level Job Interview Prep
Power of Work
/@powerofwork6914
Oct 27, 2022
This video provides an in-depth exploration of interview preparation for entry-level Trial Master File (TMF) roles within the clinical research industry. The session features Hilary Craven coaching Spencer Meyer, focusing on both technical TMF-specific questions and general behavioral interview strategies. The core objective is to equip candidates with the knowledge and communication skills to present themselves as highly capable, even with limited experience, by demonstrating a deep understanding of regulatory compliance, documentation, and the broader impact of their work. The discussion delves into critical TMF documents and their significance, such as the FDA Form 1572, which outlines the investigator's commitment to conducting a clinical trial according to protocol and regulations. Hilary emphasizes understanding not just *what* the document is, but *how* it's used for completeness reviews and as a template for other necessary site documents like CVs, medical licenses, and training records. The conversation also touches on specific lab certifications like CLIA and CAPA, highlighting the level of detail expected for "senior-level" answers. Beyond technical knowledge, a significant portion of the coaching focuses on strategic communication, including how to handle questions where the candidate lacks direct experience, stressing the importance of resourcefulness and a structured problem-solving approach. The latter part of the video shifts to broader career advice and interview tactics. It covers how to articulate what one likes and dislikes about TMF work, framing potential "grunt work" as a vital contribution to patient outcomes. The importance of the STAR (Situation, Task, Action, Result) format for behavioral questions is thoroughly discussed, with an emphasis on expanding the "Result" to encompass team, company, and ultimately, patient benefits. Practical tips for interview preparation, such as writing out and then bullet-pointing key stories, are shared. Finally, the session touches on the nuances of job application timing, working with recruiters, managing offers, and understanding travel expectations and career progression within various clinical research roles like CRA, CTA, and Study Coordinator, emphasizing the value of diverse experience for long-term career success. Key Takeaways: * **Master the 1572 Form:** Candidates for TMF roles must understand the FDA Form 1572 beyond its basic definition, including its purpose (informing the FDA, investigator commitment), its contents (PI, sub-investigators, trial name, lab address), and its use in completeness reviews for site documentation. * **Go Beyond Basic Document Knowledge:** For TMF documents like the 1572, understand its practical application, such as using it as a template to identify required supporting documents (CVs, medical licenses, training) and lab certifications (CLIA, CAPA). This demonstrates a senior-level understanding. * **Strategic Handling of Unknown Questions:** When faced with an unfamiliar question, it's acceptable to state that you're not immediately positive but would utilize resources like the TMF reference file, SOPs, or internal documentation to find the answer quickly. This shows resourcefulness and a proactive approach. * **Structured Problem-Solving:** When encountering an unknown task, the ideal approach is to first exhaust personal resources (notes, SOPs, PDFs, Google/YouTube searches) before escalating to a manager. This demonstrates self-sufficiency and due diligence. * **Connect TMF Work to a Greater Purpose:** When discussing likes/dislikes about TMF, frame the "grunt work" aspect as a dedication to detail that contributes to the larger goal of successful clinical trials, regulatory approval, and ultimately, saving or improving patient lives. This showcases passion and big-picture thinking. * **Utilize the STAR Format for Behavioral Questions:** Structure answers to behavioral questions (e.g., dealing with difficult colleagues) using Situation, Task, Action, and Result. Crucially, expand the "Result" to show multi-faceted impact, connecting personal actions to team productivity, company success, and patient benefits. * **Proactive Interview Preparation:** Over-prepare by writing out detailed answers to potential questions in STAR format, then distill these into bullet points for quick recall during the interview. This ensures refined, comprehensive responses without sounding overly scripted. * **Strategic Job Application Timing:** Apply to a wide range of positions and time applications so that interviews for highly desired roles occur after gaining experience from initial interviews. This builds confidence and refines responses. * **Understand Recruiter Dynamics:** Be aware that recruiters advocate for you but also push for quick commitments due to their compensation structure. It's advisable to take time to consider offers and discuss options before accepting. * **Diverse Clinical Research Experience is Valuable:** Roles like Study Coordinator (site-level) or CRA (travel-heavy, site monitoring) provide unique perspectives that enhance understanding and performance in TMF or CTA roles, fostering empathy and better collaboration. * **Travel Expectations are Often Overstated:** Many job descriptions list high travel percentages (e.g., 10-50%) for remote roles, but actual travel is often minimal, typically for annual off-sites or team-building events. TMF roles specifically have very limited travel. * **Importance of Team Building:** Companies with remote employees often plan annual or semi-annual in-person gatherings to foster trust and improve team dynamics, which is recognized as significantly enhancing collaboration. **Tools/Resources Mentioned:** * TMF Reference File * Standard Operating Procedures (SOPs) * PDFs (for quick searches) * Google * YouTube **Key Concepts:** * **TMF (Trial Master File):** A collection of essential documents for a clinical trial that individually and collectively permit the evaluation of the conduct of a trial and the quality of the data produced. * **1572 Form (Statement of Investigator):** An FDA form signed by the principal investigator (PI) to provide assurance that they will comply with FDA regulations for the clinical investigation of an investigational drug or biologic. * **CLIA (Clinical Laboratory Improvement Amendments):** Federal regulatory standards that apply to all U.S. facilities or sites that test human specimens for health assessment or to diagnose, prevent, or treat disease. * **CAPA (Corrective and Preventive Action):** A system for identifying, documenting, and eliminating causes of nonconformities (corrective actions) and preventing potential nonconformities (preventive actions). * **IP Shipment Form (Investigational Product Shipment Form):** A document acknowledging the receipt of investigational product (drug/device) at a clinical trial site. * **Protocol Deviation:** An unplanned divergence from the approved protocol or IRB/EC requirements. * **SIV (Site Initiation Visit):** A visit conducted by the sponsor or CRO to a clinical trial site to ensure the site is ready to begin the trial, introduce the study team, and review the protocol and procedures. * **CRA (Clinical Research Associate):** A person who monitors the progress of clinical trials at investigator sites on behalf of a sponsor or CRO. Often involves significant travel. * **CTA (Clinical Trial Assistant):** An administrative support role in clinical research, often assisting CRAs and CTMS users with documentation and trial management. * **Study Coordinator:** The primary point of contact at a clinical trial site, responsible for the day-to-day conduct of the study, patient recruitment, data collection, and regulatory compliance at the site level. * **STAR Format:** A structured method for answering behavioral interview questions by describing the Situation, Task, Action, and Result of a past experience. * **Inspection Readiness:** The state of being prepared for an audit or inspection by regulatory authorities (e.g., FDA, EMA) to ensure compliance with regulations and good clinical practice (GCP). **Examples/Case Studies:** * **Non-compliance in a study:** An example was shared where a study involving young adults on a specific diet (low red meat) experienced high non-compliance, as participants would break the diet once they felt better from the investigational drug, leading to data loss and financial implications. This highlights challenges in patient compliance and data integrity. * **TMF impact on study approval:** The discussion emphasized how a well-maintained TMF, ensuring all documents are in order, directly contributes to passing regulatory inspections, leading to study approval and ultimately, patients gaining access to needed drugs.
Audits Are a Critical Part of Continuous Improvement
ETQ Reliance: Leading Quality Management System
/@ETQReliance
Oct 24, 2022
This webinar, titled "Audits Are a Critical Part of Continuous Improvement," provides an in-depth exploration of how an integrated Quality Management System (QMS) can streamline audit processes and elevate quality from a mere compliance issue to a strategic business differentiator. Presented by David Isaacson and Tom Barlow from ETQ Reliance, the session highlights the challenges organizations face with traditional audit management and demonstrates how their QMS platform offers solutions for more effective, efficient, and compliant auditing. The presentation begins by outlining common challenges in audit management, such as wasted time on preparation, inconsistent data across multiple systems, lack of visibility into supplier information, and the limitations of paper-based or disparate electronic systems (e.g., SharePoint, Excel). It then introduces ETQ Reliance as a web-based, workflow-driven business process automation platform, featuring 42 pre-configured applications, including a core audit management module. The system is built on a highly configurable, no-code platform (ETQ Designer) hosted on Amazon Web Services (AWS), emphasizing ease of use, scalability, and future-proofing for evolving organizational needs. A significant portion of the webinar details the "genetics" or core capabilities infused across the ETQ Reliance platform: adaptability through configuration, connectivity for linking related processes and integrating with external systems (ERP, HR), contextual awareness for managing organizational hierarchies and user-specific data views, external collaboration for engaging suppliers and contractors, and anywhere access via cloud and mobile apps (including offline capabilities, voice-to-text, and camera integration for objective evidence). The audit process within ETQ Reliance is comprehensively covered, from importing existing audit types and checklists to robust audit planning, scheduling (including ad-hoc and external audits with Outlook integration), and execution using various styles (paper, web, mobile, Excel). Crucially, the system enables direct launching of follow-up actions—such as recommendations, quality events for investigations, or corrective actions (CAPAs), including supplier corrective actions—from audit findings, ensuring full traceability and accountability. The discussion extends to audit reporting capabilities, allowing for export into PDF and Excel formats, and the system's ability to facilitate continuous improvement by linking subsequent audits to previous ones, providing auditors with historical context and open issue tracking. The broader value proposition of a comprehensive QMS across the entire product lifecycle (design, suppliers, manufacturing, sales, customer feedback) is also emphasized. A case study featuring Avenos, a medical device provider, illustrates tangible benefits: $500,000 in savings and a 92% reduction in audit preparation lead time by transitioning from manual to automated audit processes, significantly reducing the risk of non-compliance and enhancing confidence with regulatory bodies like the FDA. The webinar concludes with a Q&A session, addressing practical aspects like internal auditor tips, implementation timelines, supplier audit approaches, and leveraging audit findings for trending, lessons learned, and even future AI recommendations. Key Takeaways: * **Strategic Importance of Audits:** Audits are transitioning from mere operational compliance to critical strategic initiatives and business differentiators, requiring robust management systems. * **Overcoming Audit Challenges:** Integrated QMS solutions address common pain points like time-consuming audit preparation, inconsistent data across disparate systems, lack of supplier visibility, and the limitations of paper-based processes. * **Centralized & Electronic Audit Management:** A QMS provides a single, centralized electronic system for planning, conducting, and reporting audits, making information readily available and improving overall efficiency. * **Configurability for Adaptability:** Platforms like ETQ Reliance offer high configurability without programming, using tools like a drag-and-drop designer, allowing organizations to tailor audit workflows and forms to their specific and evolving needs. * **Seamless Process Connectivity:** The QMS facilitates strong connectivity by linking related quality processes (e.g., audit findings to corrective actions or quality events) and integrating with external enterprise systems (ERP, HR) to leverage existing data. * **Contextual Awareness for Global Operations:** Large organizations can define hierarchical structures within the QMS, enabling users to view only relevant information while providing managers with comprehensive, real-time oversight across global locations or business units. * **External Collaboration:** Features like external collaboration allow organizations to involve suppliers and contractors directly in the audit process, enabling them to provide responses or participate in actions within the system. * **Anywhere Access & Mobile Capabilities:** Mobile applications with offline functionality, voice-to-text, and camera integration streamline on-site audits, allowing auditors to capture observations and objective evidence efficiently, even without internet access. * **Comprehensive Audit Lifecycle Management:** The system supports the entire audit lifecycle, from importing audit types and planning (including approval workflows) to scheduling ad-hoc and external audits, and generating detailed reports. * **Automated Follow-Up Actions:** Audit findings can directly trigger and link to follow-up actions such as recommendations, quality events (for investigations, root cause analysis, risk assessment), or corrective actions (CAPAs), ensuring issues are addressed with full traceability. * **Flexible Audit Execution:** Organizations have the flexibility to conduct audits using various methods, including paper, web-based interfaces, mobile apps, or through Microsoft Office integration (e.g., Excel spreadsheets for checklists). * **Continuous Improvement through Historical Data:** The QMS enables the linking of subsequent audits to previous ones, allowing auditors to review past responses ("previous comments") and track open issues, fostering a culture of continuous improvement. * **Quantifiable ROI:** Case studies, such as Avenos (a medical device provider), demonstrate significant financial and efficiency gains, including $500,000 in savings and a 92% reduction in audit preparation lead time. * **Reduced Risk & Improved Productivity:** Broader customer data indicates a 20% reduction in time spent planning/reporting audits, a 50% reduction in supporting external audits, and a 50% reduction in audit findings, leading to improved productivity and reduced non-compliance risk, which is vital for regulated industries. * **Leveraging Audit Learnings:** Audit findings can be used for trending analysis (via analytics tools), establishing "Lessons Learned" knowledge bases, and potentially informing future AI-driven recommendations for problem-solving. **Tools/Resources Mentioned:** * **ETQ Reliance:** The core Quality Management System platform. * **ETQ Designer:** A drag-and-drop tool for configuring the ETQ Reliance platform without programming. * **Amazon Web Services (AWS):** The cloud environment hosting ETQ Reliance. * **Outlook Calendar:** Integration for scheduling audit events and invitations. * **ETQ Insights:** An analytics tool for performing trending on past findings and creating dashboards. * **ETQ Academy:** An online learning management platform for both end-users and administrators to learn about the system. * **ETQ Community:** A platform for ETQ customers to collaborate and share information. **Key Concepts:** * **Quality Management System (QMS):** A formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. * **Harmonization:** The process of standardizing quality management approaches across different business units or global locations within an organization. * **Digital Transformation:** The integration of digital technology into all areas of a business, fundamentally changing how it operates and delivers value. * **Workflow:** A predefined sequence of steps or tasks that a process must follow within the system, ensuring consistency and accountability. * **Contextual Awareness:** The system's ability to understand a user's role and organizational context, displaying only relevant information and records. * **External Collaboration:** Extending system access and functionality to external parties like suppliers or contractors to facilitate joint processes. * **Anywhere Access:** The ability to access the system from any device (desktop, mobile) and location, including offline capabilities for mobile users. * **Corrective Action (CAPA):** A process to identify the root cause of a non-conformance or other undesirable situation and implement actions to prevent its recurrence. * **Quality Events:** A new application in ETQ Reliance designed to manage and investigate quality-related incidents, potentially leading to root cause analysis and risk assessment. * **Lessons Learned:** A process of documenting insights gained from an experience (e.g., an audit finding) to improve future performance. **Examples/Case Studies:** * **Avenos:** A medical device provider that implemented ETQ Reliance for audit management, achieving $500,000 in savings and a 92% reduction in lead time for audit preparation by automating their processes. This led to increased confidence from auditors, reduced risk of human error, and ultimately better patient outcomes. * **Johnson & Johnson:** Mentioned as a company that needed to harmonize its quality management approach to a single, broadly capable, flexible QMS. * **Vertical Farming Venture:** A company that implemented ETQ Reliance to promote food safety, higher crop yield, and improved compliance, seeing drastic time savings in audits.
9 Behavioral Economic Strategies for Doctor Pay
AHealthcareZ - Healthcare Finance Explained
@ahealthcarez
Oct 23, 2022
This video provides an in-depth exploration of nine behavioral economic strategies designed to influence physician behavior, ultimately aiming to improve quality, lower costs, and increase patient access within healthcare. Dr. Eric Bricker, referencing a seminal 2016 article from the Annals of Internal Medicine authored by a "who's who" of healthcare economics and health services research experts, critiques the prevailing fee-for-service model for its tendency to incentivize relative value unit (RVU) maximization rather than patient-centric outcomes. The core premise is that the current compensation structure is suboptimal for patient care, and behavioral economics offers actionable pathways to realign incentives. The presentation systematically unpacks each of the nine strategies, offering both theoretical underpinnings and practical examples of their application in physician compensation and practice management. Dr. Bricker emphasizes that simply educating doctors about "the right thing to do" is insufficient; effective change requires carefully structured financial and non-financial incentives. He highlights how leveraging inherent human biases, such as inertia and loss aversion, can be more potent than traditional incentive models. The discussion also touches upon the operational challenges associated with implementing these strategies, often noting that effective behavioral change frequently demands "more work" from administrative staff, contrasting with simpler but less effective approaches. Throughout the video, Dr. Bricker provides concrete illustrations, such as Intermountain Healthcare's use of care pathways as defaults in their electronic medical records to guide ventilator settings, or Mass General Hospital's practice of sending physical bonus checks to doctors' homes to enhance their perceived value. He also points out common pitfalls, like choice overload leading to decreased behavior change when too many quality metrics are introduced. The speaker's perspective is rooted in a deep understanding of both clinical practice (as an internist) and healthcare finance, allowing him to bridge the gap between academic research and real-world applicability, advocating for systemic changes over reliance on individual willpower. The overarching message is that to truly transform healthcare outcomes, compensation and operational systems must be redesigned with an understanding of human psychology. By moving beyond the limitations of fee-for-service and embracing these behavioral economic principles, healthcare organizations can create environments where physicians are naturally guided towards behaviors that enhance patient care, efficiency, and accessibility. The video serves as a compelling argument for a more sophisticated, data-driven approach to physician engagement and performance management. Key Takeaways: * **Fee-for-Service Limitations:** The current fee-for-service model primarily incentivizes the maximization of relative value units (RVUs) rather than optimizing for quality, cost-effectiveness, or patient access, necessitating alternative compensation strategies. * **Beyond Education:** Simply informing physicians about best practices or "the right thing to do" is insufficient to change behavior; effective strategies require a combination of financial and non-financial incentives. * **Leverage Defaults (Inertia/Status Quo Bias):** Design systems where desired behaviors are the default option. For example, integrate evidence-based care pathways as pre-selected choices in electronic medical records (EMRs), requiring physicians to actively opt-out for alternative actions. * **Avoid Choice Overload:** Introducing too many quality metrics or choices can paradoxically decrease desired behavior change. A "Goldilocks" approach—not too few, not too many—is crucial for effective physician engagement and focus. * **Increase Incentive Immediacy:** Annual incentives are often too infrequent to drive sustained behavior change. More frequent feedback and rewards (e.g., weekly, monthly, quarterly) can significantly improve the effectiveness of both financial and non-financial incentives, despite requiring more administrative effort. * **Harness Loss Aversion:** People are generally more motivated to avoid losing something they possess than to gain something new. Structuring incentives as an upfront bonus that can be taken away if performance targets are not met can be more effective than offering a bonus at the end of a period. * **Utilize Relative Social Ranking:** Transparently comparing physician performance by name within a group can be a powerful motivator. Publicly displaying metrics like immunization rates, even for individual physicians, can drive improvement among lower performers and elevate overall group performance. * **Account for Threshold Effect:** Physicians will work harder as they approach a goal or threshold, but once that goal is met, their effort may decrease. Incentive structures should anticipate this effect, potentially by introducing new thresholds or continuous goals to maintain motivation. * **Systematize Beyond Willpower:** Relying on individual physician vigilance for tasks like preventive care gap closure is unsustainable and contributes to burnout. Instead, implement systemic solutions, such as empowering nurses to manage and follow up on preventive screenings and immunizations, removing the burden from physicians. * **Employ Mental Accounting:** The way a bonus is delivered impacts its perceived value. Separating bonus payments from regular paychecks (e.g., sending a physical check to a home address, as Mass General did) makes the bonus stand out and reinforces its connection to specific achievements. Key Concepts: * **Behavioral Economics:** The study of the effects of psychological, social, cognitive, and emotional factors on the economic decisions of individuals and institutions, and how those decisions vary from those implied by classical theory. * **Fee-for-Service (FFS):** A payment model where services are unbundled and paid for separately. In medicine, it gives an incentive for physicians to provide more treatments because payment is dependent on the quantity of care, rather than quality. * **Relative Value Unit (RVU):** A measure of value used in the U.S. Medicare reimbursement formula for physician services. It is a component of the resource-based relative value scale (RBRVS). * **Inertia/Status Quo Bias:** A cognitive bias where people have a strong tendency to prefer the current state of affairs, or to do nothing, rather than make a change. * **Loss Aversion:** A cognitive bias that describes why, for individuals, the pain of losing is psychologically more powerful than the pleasure of gaining. * **Mental Accounting:** The tendency for people to separate their money into different mental accounts based on subjective criteria, like the source or intended use of the money. Examples/Case Studies: * **Intermountain Healthcare System:** Implemented care pathways as defaults in their hospital systems (e.g., for ventilator settings in the ICU) to ensure evidence-based care was the standard, requiring doctors to actively choose an alternative. * **Outpatient Primary Care Physician Group:** Used relative social ranking by publicly displaying individual physician immunization rates (pre-COVID) for adult immunizations. This led to significant improvement in rates, particularly among those with lower initial performance. * **Mass General Hospital:** Employed mental accounting by sending individual, hard-copy bonus checks to doctors' home addresses, rather than integrating them into regular electronic paychecks, to make the bonus stand out and increase its perceived value. * **Outpatient Clinic (Systematization):** Shifted the responsibility for reviewing preventive care gaps and following up on screenings and immunizations from physicians to nurses, recognizing the unsustainability of relying on physician willpower and vigilance.
MPDmanager Powered by CARA - EXTEDOs IDMP Software and Master Data Management Solution
EXTEDO
/@EXTEDOpulse
Oct 20, 2022
This video provides an in-depth exploration of EXTEDO's MPDmanager, a regulatory information and activity management solution powered by CARA and integrated into the broader EXTEDO pulse platform. It addresses the escalating challenge of managing complex product information while adhering to an ever-changing global regulatory landscape. The solution aims to offer a comprehensive approach to all product and lifecycle-related topics within the pharmaceutical and life sciences industries, emphasizing a user-friendly and intuitive interface to streamline the organization and management of controlled vocabularies, master product data registrations worldwide, and associated activities. The MPDmanager platform is designed with a focus on user efficiency and data integrity. Its interface features a customizable toolbar, a navigation tree for browsing and selecting data records, and a central main view panel for displaying information. Users can subscribe to records for change notifications, add items to a favorites list, and create or utilize predefined tags for quick access to information. The system supports individual filtering, export of data to Excel, and advanced search functionalities that can be saved and shared among colleagues. A dedicated widget panel provides detailed information about highlighted records, including version history and related activities, ensuring a holistic view of product data. A core strength of MPDmanager lies in its robust regulatory compliance features, particularly its integrated Controlled Vocabulary (CV) management. This system incorporates SPOR vocabularies, ensuring that product data is, by default, compliant with XEVMPD and IDMP standards. These controlled vocabularies are centrally managed and utilized across the entire platform to construct product data, beginning with the "core product" concept. The core product serves as a country and region-independent corporate template, designed to facilitate the easy creation of registration information by reusing already available data. This foundational approach ensures consistency and efficiency, with the "registered product" then displaying country-specific data for planned or registered products, providing essential business-relevant data for overviews, reports, and detailed information that can be easily exported or transmitted in a compliant XEVMPD/IDMP format. Beyond data management, MPDmanager significantly streamlines the regulatory submission process. It enables effortless creation and management of medicinal product registrations, allowing users to add specific data using free text, calendars, or controlled vocabularies, often by simply adjusting existing core product information. The system facilitates the planning of multiple activities for one or more products, integrating warnings for upcoming deadlines and allowing planned activities to be related to change requests. A key automation feature is the ability to trigger the sequence creation for electronic submissions with a single click. This action generates a notification in the EXTEDO pulse publishing app, informing regulatory operations teams. The dossier information is then automatically pulled from previously created regulatory activities, and in combination with EXTEDO's DMS Hub, metadata and documents are automatically added, making the submission compilation process highly efficient and reducing manual effort. EXTEDO's extensive experience of over 25 years and partnerships with more than 35 regulatory authorities worldwide underscore the solution's credibility and effectiveness in ensuring rapid compliance with global regulatory changes. Key Takeaways: * **Comprehensive Regulatory Compliance:** MPDmanager is purpose-built to navigate the complexities of global regulatory compliance, specifically addressing IDMP and XEVMPD standards for managing product information in an ever-changing landscape. * **Integrated Master Data Management (MDM):** The solution offers a comprehensive approach to master data management for regulated products, encompassing controlled vocabularies, core product data, and country-specific registered product information. * **Automated XEVMPD/IDMP Compliance:** It features integrated Controlled Vocabulary (CV) management with SPOR vocabularies, ensuring that all data is inherently XEVMPD and IDMP compliant, which is critical for international regulatory submissions. * **Efficient Core Product Data Reuse:** The "core product" concept serves as a country and region-independent corporate template, enabling the efficient reuse and adjustment of existing data to generate country-specific registration information, thereby minimizing redundancy and potential errors. * **Streamlined Registration Workflow:** The platform simplifies the creation and management of medicinal product registrations, allowing users to easily add specific data using various input methods and leveraging existing core product information. * **Proactive Activity and Deadline Management:** MPDmanager supports the planning of multiple activities for products, integrates warnings for upcoming deadlines, and links activities to change requests, fostering a proactive approach to regulatory compliance. * **Automated Electronic Submission Compilation:** A significant feature is the automation of electronic submission sequence creation, which notifies regulatory operations teams and automatically compiles dossiers with metadata and documents, drastically reducing manual effort and improving submission accuracy. * **User-Friendly and Customizable Interface:** The system provides an intuitive interface with customizable columns, individual filtering, quick access options (favorites, tags), and advanced search capabilities, enhancing user productivity and data accessibility. * **Robust Data Search and Filtering:** Users can perform advanced searches and apply property filters to quickly pinpoint specific information, such as planned marketing authorization applications based on country or procedure type, facilitating targeted data retrieval. * **Collaborative Data Sharing:** The platform allows for the export of information to Excel and the sharing of saved searches or tags with colleagues, promoting collaboration and consistent data access across teams. * **Graphical Data Visualization:** Records can be displayed in a graphical view within the main panel, offering alternative perspectives for data analysis and reporting, which can aid in understanding complex relationships. * **Industry Expertise and Trust:** EXTEDO's extensive experience (over 25 years) and established relationships with more than 35 regulatory authorities worldwide underscore the solution's reliability and its ability to meet stringent regulatory demands. Tools/Resources Mentioned: * **MPDmanager:** EXTEDO's Master Data Management solution for regulated products. * **CARA:** The underlying platform powering MPDmanager. * **EXTEDO pulse platform:** The integrated platform of which MPDmanager is a part. * **EXTEDO pulse publishing app:** Used for notifications regarding upcoming electronic submissions. * **EXTEDO's DMS Hub:** Utilized for pulling dossier information, metadata, and documents for submissions. * **SPOR vocabularies:** Standardized vocabularies used for IDMP and XEVMPD compliance. Key Concepts: * **IDMP (Identification of Medicinal Products):** International standards developed by ISO for the unique identification of medicinal products, essential for global regulatory compliance and data exchange. * **XEVMPD (Extended EudraVigilance Medicinal Product Dictionary):** A European Medicines Agency (EMA) standard for submitting and managing medicinal product information within the EU. * **Master Data Management (MDM):** A process that ensures consistency and control over an organization's core data, providing a single, accurate, and authoritative source of truth for critical business entities like products. * **Controlled Vocabularies (CVs):** Standardized sets of terms or phrases used to ensure consistency, accuracy, and interoperability in data entry, retrieval, and regulatory submissions. * **Core Product:** A foundational, country and region-independent template for product master data, designed to be reused and adapted for various country-specific registrations. * **Registered Product:** Country-specific data pertaining to planned or registered products, built upon the core product information and tailored for local regulatory requirements. * **Regulatory Information and Activity Management:** Systems and processes designed to manage all information, documents, and activities related to regulatory submissions, approvals, and ongoing compliance for regulated products. Examples/Case Studies: * The video illustrates how property filters can be used to identify specific information, such as "all planned marketing authorization applications in specific countries or according to their procedure type." * It demonstrates the efficiency of creating new registration information by "reusing and adjusting existing core product information." * The system facilitates planning "several activities for one or multiple products," with integrated "warnings" for upcoming deadlines. * A key example of automation is the "sequence creation with a simple click on the button" for electronic submissions, which then "Auto created upon confirmation of the received task," pulling dossier information and automatically adding metadata and documents.
Registrations: Creating a "Light" Regulatory Action
Envu's Guide Through Veeva Vault
/@envusguidethroughveevavaul5558
Oct 19, 2022
This video provides a practical, step-by-step guide on creating a "light" regulatory action within Veeva Vault, specifically tailored for product transfers that do not necessitate extensive supporting documentation. The primary purpose is to streamline the regulatory process for scenarios where the registration manager can trust that minimal additional data or documents are required. The context is set around product transfers, using the example of a transfer from Bayer to Envu, emphasizing the critical data points that still need to be captured, such as the registration certificate, approval date, and any changes to product names, involvements, or registration numbers. The speaker details the progression of creating such an action, beginning with navigating to the registration section in Veeva Vault, filtering for relevant registrations (e.g., Germany's r421), and conducting an initial audit of existing product data for cleanliness and accuracy. A crucial step involves creating a new regulatory action and specifically selecting "Entity Change Product Transfer," which is vital for linking the action to collaborative platforms like a SharePoint site for bear transfers. The video highlights that for these "light" actions, a dossier or binder structure is often unnecessary, but provisions are made for attaching general documents if needed. A key aspect of the process involves managing the state of the regulatory action. The speaker demonstrates how the system can be configured to allow direct approval for actions that have already been submitted and approved externally, saving time for registration managers. However, a common pitfall is encountered: the system will prevent moving an action to "submitted" or "approved" without an uploaded registration certificate or confirmation letter. This leads to a detailed explanation of how to add a "received document," including uploading the certificate and populating its metadata (date, country, territory, language, issuing organization, product). Finally, the video covers updating the core registration details, such as product names or registration numbers, and critically, updating the "product involvement" to reflect the company's current role (e.g., registration holder) post-transfer, ensuring all associated contact information is accurate. Key Takeaways: * **"Light" Regulatory Actions Defined:** These are designed for processes like product transfers where the registration manager determines that extensive supporting documents or complex documentation structures (like binders) are not required, streamlining the workflow. * **Essential Data Capture:** Even in a "light" process, it is crucial to upload the registration certificate, document the approval date, and meticulously record any changes to product names, product involvements, or registration numbers. * **Opportunity for Data Audit:** Product transfer processes, which often involve touching numerous registrations, present an excellent opportunity to audit existing product data in Veeva Vault, ensuring accuracy and completeness. * **Step-by-Step Action Creation:** The process begins by navigating to the registration section, filtering for specific registrations, reviewing existing data, and then initiating a new regulatory action. * **Crucial Action Type Selection:** When creating the new regulatory action, it is imperative to select "Entity Change Product Transfer." This specific selection is vital for linking the action to external collaborative sites, such as a SharePoint site for transfer data. * **Flexible Document Handling:** For "light" actions, a dossier or binder structure is typically not needed. However, if additional documents are required, users can select "General documents without binder" to attach them directly. * **Streamlined Approval Workflow:** Veeva Vault can be configured to allow regulatory actions for specific processes to be pushed directly to an "approved" state, bypassing the "submitted" status, which significantly saves time for registration managers when actions have already been approved externally. * **Mandatory Document Upload for Approval:** A critical system validation prevents moving a regulatory action to "submitted" or "approved" without first uploading the official registration certificate or confirmation letter as a "received document." * **Detailed Received Document Process:** To overcome the approval block, users must navigate to the "received document" section, upload the registration certificate, and accurately fill in its metadata, including date, country, territory, language, issuing organization, product, and ensuring the regulatory action is automatically linked. * **Updating Registration Details:** Post-approval, it is essential to return to the main registration section to update any changes to the registration number or product name resulting from the transfer. * **Managing Product Involvement:** A new "product involvement" object must be created or updated to reflect the company's current role with the product (e.g., registration holder, distributor). This includes associating the correct company and contact information. * **Contact for Missing Data:** If any necessary data points (e.g., company names for product involvement) are missing in the system, users are advised to contact the Veeva team for assistance in adding them. Tools/Resources Mentioned: * **Veeva Vault:** The primary platform for managing registrations and regulatory actions. * **SharePoint:** Mentioned as a collaborative site for linking transfer data. Key Concepts: * **Light Regulatory Action:** A simplified regulatory action process in Veeva Vault for transfers or changes with minimal documentation requirements. * **Regulatory Action:** A formal process recorded in Veeva Vault to document changes, approvals, or transfers related to product registrations. * **Registration Certificate:** The official document confirming product registration and approval, mandatory for moving regulatory actions to an approved state. * **Product Involvement:** Defines the company's role or relationship with a specific product (e.g., registration holder, distributor). * **Entity Change Product Transfer:** A specific type of regulatory action in Veeva Vault used to document the transfer of product ownership or responsibility between entities.
Top 5 Largest Healthcare Consulting Firms
AHealthcareZ - Healthcare Finance Explained
@ahealthcarez
Oct 16, 2022
This video provides an in-depth exploration of the top five largest healthcare consulting firms in America, as ranked by Modern Healthcare. Dr. Eric Bricker, the speaker, begins by establishing the crucial role of these firms in shaping the strategic and operational direction for hospitals, health plans, and other healthcare stakeholders, particularly in the context of healthcare finance. A central theme throughout the discussion is Revenue Cycle Management (RCM), which is presented as a primary service offered by these leading consultants. RCM encompasses the entire process from patient admission and pre-registration, insurance verification, charge capture, billing, collections, and finally, cash posting, with the ultimate goal of helping hospitals get paid more, faster. The video systematically details each of the top five firms, providing their healthcare consulting revenue and specific insights into their operations. Deloitte leads the list with $963 million in healthcare consulting revenue, representing about 36% of its total consulting business. Guidehouse, formed from a combination of firms, ranks second in RCM consulting with $485 million in healthcare revenue and approximately 3,500 healthcare consultants. Optum, a division of UnitedHealth Group, is presented as the third largest, with $755 million in total consulting, though its provider-side consulting places it at number three. The speaker highlights a potential conflict of interest with Optum, as its consulting arm helps hospitals increase revenue while another part of UnitedHealth Group aims to lower healthcare costs for employers. Vizient, a major Group Purchasing Organization (GPO), holds the fourth spot with $210 million in consulting revenue, also focusing on RCM. Finally, Huron Consulting Group, where Dr. Bricker himself once worked, rounds out the top five with $378 million in annual consulting revenue, specializing in RCM projects. Beyond the ranked firms, the video acknowledges McKinsey & Company's significant, albeit less transparent, presence in healthcare consulting, serving hospitals, health insurance companies, and pharmaceutical companies through its "Healthcare Systems and Services" division. Dr. Bricker concludes with a poignant "punch line," expressing a wish that these powerful consulting firms would shift their focus from revenue cycle optimization to clinical optimization. He argues that addressing the massive variability in cost and quality within hospital systems and across different facilities and physicians would be a more impactful use of their expertise, ultimately leading to better patient outcomes and more efficient healthcare delivery. Key Takeaways: * **Dominant Healthcare Consulting Firms:** The top five largest healthcare consulting firms in America by revenue are Deloitte ($963M), Guidehouse ($485M), Optum ($755M total consulting, ranked #3 for provider-side), Vizient ($210M), and Huron Consulting Group ($378M). These firms play a critical role in the strategic and operational direction of hospitals and health plans. * **Revenue Cycle Management (RCM) as a Core Service:** A primary focus for these large consulting firms is Revenue Cycle Management (RCM), which involves optimizing the entire billing and collections process for hospitals. This includes pre-registration, insurance verification, charge capture, coding, billing, follow-up, and cash posting, with the goal of getting hospitals paid more, faster. * **Scale of Operations:** These firms operate at a massive scale, with Deloitte's healthcare consulting alone generating nearly a billion dollars annually and employing an estimated 7,000 healthcare consultants. Guidehouse has approximately 3,500 healthcare consultants. * **Optum's Conflict of Interest:** Optum, as part of UnitedHealth Group, presents a potential conflict of interest. Its consulting division helps hospitals optimize charge capture and accelerate payments, which can increase healthcare costs, while another part of UnitedHealth Group aims to lower healthcare costs for employers and health plans. * **GPOs in Consulting:** Group Purchasing Organizations (GPOs) like Vizient, primarily known for bulk purchasing for hospitals, also have substantial consulting arms that offer services like revenue cycle consulting, demonstrating the diverse service offerings within the healthcare ecosystem. * **McKenzie's Strategic Role:** While not on the Modern Healthcare list (due to being a private company and less transparent about revenue), McKinsey & Company is a significant player in healthcare consulting, advising hospitals, health insurance companies, and notably, pharmaceutical companies through its "Healthcare Systems and Services" practice. This highlights the broader scope of strategic consulting beyond just provider operations. * **Call for Clinical Optimization:** The speaker advocates for a shift in focus from financial optimization (RCM) to clinical optimization. He argues that consultants should help hospitals reduce the massive variability in cost and quality of care across different physicians, facilities, and treatment scenarios within the same health system. * **Impact of Operational Variability:** Significant clinical variability exists within healthcare systems, meaning patients with the same condition might receive vastly different care and outcomes depending on where or by whom they are treated. Addressing this variability through clinical improvement programs could lead to substantial benefits in patient care and efficiency. * **Market Context for AI Solutions:** Understanding the focus of these large consulting firms on operational efficiency (like RCM) provides context for how AI and data engineering solutions could integrate or compete. AI-powered tools could automate or optimize aspects of RCM or, more broadly, contribute to the desired clinical optimization. * **Strategic Importance of Consulting:** Healthcare consulting firms provide essential strategic and operational guidance, influencing how healthcare organizations manage their finances, operations, and patient care delivery. Their recommendations have a direct impact on the financial health and operational efficiency of hospitals and other entities.
Is Virtual or In-Person Sales Better? The Pros & Cons of Each
Self-Funded
@SelfFunded
Oct 11, 2022
This video provides an in-depth exploration of the advantages and disadvantages of virtual versus in-person sales approaches, offering a balanced perspective on which method is more effective in different scenarios. The speaker, a seasoned salesperson with experience in SaaS, shares insights derived from adapting to virtual selling during the pandemic after years of traditional in-person engagement. The core purpose of the video is to help sales professionals understand the shifts in the sales landscape and equip them with the knowledge to navigate both virtual and physical sales environments successfully. The discussion begins by highlighting the significant efficiencies offered by virtual sales. The speaker emphasizes that virtual platforms like Zoom enable salespeople to conduct significantly more meetings in a single day—potentially 8 to 12 back-to-back—an impossibility with the travel demands of in-person interactions. This efficiency directly translates to cost savings, as virtual selling eliminates expenses related to travel, gas, flights, hotels, and event spaces. However, the video quickly transitions to the critical drawbacks of virtual sales, primarily the difficulty in building genuine rapport and relationships over a screen. The speaker notes the challenge of gauging audience attention and engagement when cameras are off, leading to a less human and potentially less effective interaction. Conversely, the video champions in-person sales for its unparalleled ability to foster deep relationships and build trust. Being physically present allows for the reading of non-verbal cues, shared experiences like meals or happy hours, and a more human connection that is difficult to replicate virtually. The speaker argues that trust, a foundational element of business, is more effectively established when individuals meet face-to-face, allowing for a better understanding of a person's "vibe" and presence. Despite these profound benefits, in-person sales come with substantial financial costs, with the speaker citing examples of trips costing thousands of dollars for just a few meetings. Furthermore, in-person selling drastically limits the number of meetings possible in a day due to travel time and logistical complexities, and scheduling has become increasingly difficult as fewer people are inclined to meet physically. The speaker concludes by advocating for a hybrid approach, acknowledging the inherent value in both methodologies. While expressing a personal preference for the relationship-building aspects of in-person sales, the speaker cannot deny the undeniable efficiency and outcome-driven success achieved through virtual selling, particularly for SaaS products. The overarching message is that the sales industry has permanently shifted, and modern salespeople must adapt and adopt virtual selling skills, not as a replacement for the human element, but as an augmentation to their overall sales capabilities, requiring flexibility to excel in both realms. Key Takeaways: * **Virtual Sales Efficiency:** Virtual platforms allow for a significantly higher volume of meetings per day (8-12), making the sales process much more efficient compared to in-person engagements. * **Cost Savings in Virtual Sales:** Eliminating travel expenses, including gas, flights, hotels, and event spaces, makes virtual selling substantially cheaper from a profit and loss perspective for companies. * **Rapport Building Challenges Virtually:** It is considerably harder to build deep rapport and strong relationships over a screen, as non-verbal cues and genuine human connection are often diminished. * **Audience Engagement Issues in Virtual Settings:** Salespeople may struggle to ascertain if their audience is truly attentive during virtual calls, especially when cameras are off, potentially leading to less effective communication. * **Superior Relationship Building In-Person:** In-person interactions are paramount for fostering deeper relationships, allowing for better reading of non-verbal cues, shared experiences, and a more human connection. * **Trust as a Foundation of In-Person Sales:** Building trust, which is crucial for business transactions, is significantly enhanced through physical presence, as it allows for a more comprehensive assessment of a person's character and intentions. * **Higher Cost of In-Person Sales:** Traditional sales methods are expensive, with travel, accommodation, and entertainment costs easily accumulating to hundreds or even thousands of dollars for just a few meetings. * **Limited Meeting Capacity In-Person:** The logistical demands of in-person sales, such as travel time between locations, drastically reduce the number of meetings a salesperson can conduct in a single day (e.g., 4-5 meetings compared to 10-12 virtually). * **Increased Difficulty in Scheduling In-Person Meetings:** Post-pandemic, scheduling physical meetings has become more challenging as fewer individuals are inclined or available to meet in person, often requiring longer lead times. * **Hybrid Approach is Optimal:** The most effective sales strategy involves leveraging both virtual and in-person methods, utilizing virtual for efficiency and reach, and in-person for critical relationship and trust building. * **Adaptation to Virtual Selling is Crucial:** Sales professionals must develop and embrace virtual selling skills as a core competency, recognizing that this approach is here to stay and augments, rather than replaces, traditional methods. * **SaaS Sales Benefits from Virtual Efficiency:** For products like Software as a Service (SaaS), virtual demonstrations and sales processes are highly efficient and can lead to better outcomes due to the ease of screen sharing and remote interaction. Tools/Resources Mentioned: * Zoom * Microsoft Teams * WebEx Key Concepts: * **Virtual Sales:** Conducting sales interactions and presentations remotely using video conferencing platforms. * **In-Person Sales:** Traditional sales methods involving physical meetings and face-to-face interactions. * **Rapport:** A close and harmonious relationship in which the people or groups concerned understand each other's feelings or ideas and communicate well. * **Efficiency:** The ability to achieve maximum productivity with minimum wasted effort or expense. * **Trust:** Firm belief in the reliability, truth, ability, or strength of someone or something, crucial for business transactions. * **Non-verbal Cues:** Communication through body language, facial expressions, gestures, and other physical signals, often more easily interpreted in person. Examples/Case Studies: * The speaker's personal experience selling SaaS (Software as a Service) and adapting to virtual selling during the pandemic. * An example of covering the Oklahoma City and Tulsa markets from Dallas, illustrating the time and logistical challenges of in-person travel and limited meeting capacity (3-hour drive, 4-5 meetings max per day).
Episode 4: How Clean is Your Data?
Veeva Systems Inc
/@VeevaSystems
Oct 10, 2022
This video provides an in-depth exploration of the evolving landscape of clinical data management, featuring a conversation between Richard Young, Vice President of Vault CDMS Strategy at Veeva, and Trevor Griffiths, Senior Director of Clinical Data Management at Syneos Health. The discussion centers on the increasing complexity of clinical trials due to diverse data sources and the transformative role of technology, particularly AI and machine learning, in streamlining data cleaning and management processes. Both speakers, with over two decades of experience in data management, reflect on the industry's shift from traditional paper-based methods to a highly digital and integrated approach. The conversation highlights a significant change in the CRO industry, where clinical trials now commonly involve 10 to 12 different data sources, moving beyond traditional EDC and central labs to include wearables, bedside monitors, and handheld devices. This diversification necessitates a robust digital clinical trial (DCT) strategy. A key revelation is Syneos Health's success in eliminating over 3,000 hours of manual data review in a single large trial through the application of machine learning. This efficiency gain underscores a fundamental shift in the data manager's role, moving away from repetitive, manual tasks towards more strategic functions, with data managers evolving into "data scientists" who are pivotal to the early stages of trial design and overall data strategy. The speakers also delve into the capabilities of platforms like Veeva CDB, which facilitates the collation of data from multiple sources, enables centralized cleaning, and allows for automated query generation back into EDC systems or direct notification to vendors. This integrated approach is crucial for managing the increased number of stakeholders and data streams, especially under growing pressure to shorten database lock timelines. The discussion concludes with a forward-looking perspective, envisioning a future where manual data review is entirely eliminated, data formats are standardized across the industry, and true data lake strategies enable seamless data capture without complex integrations, ultimately driving higher quality and efficiency in clinical trials. Key Takeaways: * **Evolution of Clinical Data Management:** The industry has transitioned from primarily paper-based CRFs to EDC, and now faces a new era of highly diverse digital data sources, with 10-12 different types of data (e.g., EDC, central labs, IVRS, wearables, bedside monitors) becoming standard in a single clinical trial. * **Transformative Impact of AI and Machine Learning:** AI and machine learning are proving instrumental in cleaning clinical data, particularly in automating manual review processes. Syneos Health successfully reduced manual cleaning effort by over 3,000 hours on a single large trial using these technologies. * **Shifting Role of the Data Manager:** The data manager's role is evolving from a task-oriented position focused on manual cleaning to a more strategic "data scientist" role. They are becoming pivotal team members involved earlier in trial design, focusing on data strategy, analytics, and coordination rather than minutiae. * **Investment in Data Science Skills:** Companies like Syneos Health are actively investing in "data scientist districts" and providing training to upskill existing data managers, equipping them with the necessary skills to handle diverse data types and leverage advanced analytical tools. * **Centralized Data Platforms are Crucial:** Platforms like Veeva CDB are essential for collating data from multiple sources into a central location, enabling comprehensive review, automated query generation back to EDC, and efficient notification of data issues to vendors. * **Pressure on Database Lock Timelines:** Despite the increased complexity and number of data sources, there is growing pressure to shorten database lock timelines. This is being achieved through the strategic use of AI/ML and robust project and stakeholder management. * **Importance of Early CRO Involvement:** CROs bring extensive experience with diverse DCT vendors and technology solutions. Their early involvement in protocol design can provide thoughtful input, ensuring optimal data collection methods and vendor selection from the outset. * **Desire for No-Code Listing Creation:** A significant pain point is the need for programming complex listings. The industry desires systems where data managers can create listings by clicking and dragging or using simple, function-based code, reducing the reliance on specialized programming. * **Advocacy for Industry-Wide Data Standardization:** The lack of universal data format standardization (beyond CDASH and SDTM) across the industry is a major inefficiency. There is a strong call for a common, standardized format to enhance efficiency and simplify data journeys. * **Vision for a True Data Lake Strategy:** The ideal future state includes a system capable of capturing all different data formats without any integration effort, implying an intelligent data lake that can ingest and interpret diverse data automatically. * **Elimination of Manual Data Review:** The ultimate goal for data cleaning is to remove all forms of manual review, with cleaning processes being entirely electronic or handled by AI/machine learning to drive increased efficiency and quality. * **Potential Evolution of the CRA Role:** While CRAs will always be needed, some of their responsibilities, particularly those related to remote monitoring and source data verification, could transition due to increased data availability and central monitoring capabilities. * **Interactive Patient Profiles:** A desired capability is an interactive patient profile that allows for a holistic, manual "sanity check" of patient data, capturing cumulative review insights to inform and predefine additional edit checks and rules. **Tools/Resources Mentioned:** * **Veeva CDB:** Veeva’s clinical data platform for complete and concurrent data, designed to collate data from multiple sources and facilitate cleaning. * **EDC (Electronic Data Capture):** Standard system for capturing clinical trial data. * **IVRS (Interactive Voice Response System):** Used for randomization and drug supply management. **Key Concepts:** * **Clinical Data Management (CDM):** The process of collecting, managing, and ensuring the quality of data for clinical trials. * **Decentralized Clinical Trials (DCTs):** Clinical trials where some or all trial-related activities occur at participants' homes or local sites, often leveraging digital technologies and diverse data sources. * **FSP (Functional Service Provider):** A model where a pharmaceutical company outsources specific functions (like data management) to a CRO. * **Data Scientist District:** An internal initiative by Syneos Health to train and evolve their data managers into data scientists, equipping them with advanced analytical and data handling skills. * **Data Lake Strategy:** An approach to data storage that involves storing large amounts of raw data in its native format until it's needed, with the ability to capture diverse data types without prior integration definitions. * **CDASH (Clinical Data Acquisition Standards Harmonization) & SDTM (Study Data Tabulation Model):** Standards developed by CDISC (Clinical Data Interchange Standards Consortium) for collecting and submitting clinical trial data. **Examples/Case Studies:** * **Syneos Health's Machine Learning Implementation:** Syneos Health successfully reduced over 3,000 hours of manual data review on a single large clinical trial by implementing machine learning algorithms for data cleaning.
eDOCSmanager Powered by CARA - EXTEDO's Document Management Solution for Life Sciences
EXTEDO
/@EXTEDOpulse
Oct 10, 2022
This video provides an in-depth exploration of eDOCSmanager, EXTEDO's document and content management solution specifically designed for the life sciences industry. The presentation begins by establishing the critical need for accuracy, consistency, efficiency, and quality in all business processes involved in developing highly complex and regulated products within this sector. eDOCSmanager is introduced as a comprehensive solution integrated within the EXTEDOpulse platform, addressing document management needs across clinical, quality, SOP, and regulatory tasks, with the flexibility to support both local installations and cloud solutions based on company policy. The video then delves into the user-friendly and intuitive interface of eDOCSmanager, designed to facilitate easy organization, collaboration, and review of content and documents online. It highlights key interface elements such as the main menu button, context-sensitive toolbar buttons that adapt to user permissions, and user profiles for setting preferred channels and languages for notifications about document changes and workflow tasks. The modular design is showcased through the "regulatory module," where views are tailored to specific document types, allowing users to navigate between modules based on their permissions. The navigation panel on the left provides access to folders, while the central main view panel lists selected documents, offering customizable sort orders and displayed properties. A significant portion of the video focuses on addressing the challenging task of finding data within complex document repositories. eDOCSmanager tackles this by enabling property-based navigation, allowing users to group documents into folders based on various dimensions like domain, group, product, and market. Beyond structured navigation, the solution offers features like document subscriptions for update notifications, shared tags for collaboration, and shortcuts to frequently accessed items, including "Last Action items" and "last 100 items accessed." Property filters further refine displayed document lists, exemplified by filtering for documents prepared for the US that are not yet part of a submission, with the option to graphically display results. Content creation is also streamlined, offering options to create placeholders, quickly generate documents using pre-made forms and templates, and integrate specialized templates like EXTEDO eCTD, ensuring only relevant templates are displayed to the user. Finally, the video emphasizes eDOCSmanager's robust workflow capabilities and its role in ensuring regulatory compliance. After authoring content, users can send it through a defined workflow for review or approval, with the flexibility to specify recipients, their sequence, and whether tasks require completion by one or all. Documents transition between life cycle states either automatically upon task completion or manually. The presentation concludes by highlighting EXTEDO's extensive experience of over 20 years and its trusted position as a vendor for more than 35 regulatory authorities worldwide. This deep industry and authority experience has culminated in a solution that is easy to use, provides a comprehensive content management environment, and ensures rapid compliance with the latest global regulatory changes. Key Takeaways: * **Unified Document Management for Life Sciences:** eDOCSmanager serves as a comprehensive document and content management solution specifically tailored for clinical, quality, SOP, and regulatory tasks within the life sciences industry, consolidating diverse documentation needs into a single platform. * **Regulatory Compliance at Core:** The solution is engineered to meet the demanding needs of life sciences companies, ensuring rapid compliance with global regulatory changes, a critical aspect given EXTEDO's experience with over 35 regulatory authorities. * **Flexible Deployment and Configuration:** It supports both local installations and cloud solutions, offering high configurability to allow easy and incremental adjustments to business processes to match specific organizational needs and regulatory requirements. * **Enhanced Collaboration Features:** The platform facilitates online collaboration and review of documents, incorporating built-in electronic signatures and integrations with external services like Adobe Sign and DocuSign for streamlined approval processes. * **Intuitive User Interface:** A user-friendly interface with context-sensitive toolbar buttons, customizable views, and personalized settings (e.g., preferred language, notification channels) aims to improve user efficiency and reduce the learning curve. * **Advanced Document Discovery and Navigation:** Addresses the challenge of finding data through property-based navigation, allowing documents to be grouped and filtered by dimensions such as domain, product, and market, significantly improving searchability. * **Proactive Information Management:** Users can subscribe to documents for change notifications, create shared tags for team organization, and utilize shortcuts to frequently accessed items, enhancing proactive document management. * **Streamlined Content Creation:** Offers various options for content creation, including placeholders, pre-made forms, and templates, with specific integration for EXTEDO eCTD templates to ensure quick access to relevant departmental templates. * **Robust Workflow Management:** Provides flexible workflow definition for review and approval processes, allowing administrators to specify recipients, their sequence, and the conditions for task completion, supporting both automatic and manual life cycle state transitions. * **Centralized Data Access and Traceability:** As part of the EXTEDOpulse platform, eDOCSmanager enables access to all data and documents through a common interface, promoting seamless collaboration, discovery, and traceability across an organization by eliminating disparate repositories. * **Detailed Document Information:** Widgets provide detailed information about documents, including version history and relations with other documents or activities, enhancing context and understanding of interconnected information. Tools/Resources Mentioned: * EXTEDOpulse platform * Adobe Sign * DocuSign * EXTEDO eCTD templates Key Concepts: * **Document Management Solution (DMS):** A system used to store, manage, and track electronic documents and electronic images of paper-based information. * **Content Management Solution (CMS):** A system used to manage the creation and modification of digital content. * **Electronic Signatures:** Digital representations of a signature used to authenticate a document or data, often critical for regulatory compliance (e.g., 21 CFR Part 11). * **Workflow Management:** The automation of business processes, in this context, specifically for document review, approval, and life cycle transitions. * **Regulatory Compliance:** Adherence to laws, regulations, guidelines, and specifications relevant to the life sciences industry (e.g., FDA, EMA, GxP, 21 CFR Part 11).