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6:12

Trial Master File (TMF) for Sponsors: Set Up and Maintenance

Kathy Barnett

/@kathybarnett4070

Dec 9, 2021

This video provides an in-depth exploration of the Trial Master File (TMF) for sponsors, focusing on its setup, maintenance, and critical role in demonstrating regulatory compliance and study conduct. Donna Dorzinski, a member of the TMF Reference Model steering committee and founder of Just In Time GCP, guides the audience through the evolving landscape of TMF management. She emphasizes that the TMF is not merely a collection of documents but the "story of your study," serving as the cornerstone for inspections and evidence of a sponsor's fulfillment of obligations to health authorities. The presentation delves into the rationale behind a robust TMF, highlighting the sponsor's ultimate accountability, even when a Contract Research Organization (CRO) manages the file. It underscores that without proper documentation, actions are considered undone, particularly in the eyes of an inspector. The video traces the regulatory basis for TMF, referencing protocol regulations, EU directives, and ICH guidelines, noting an anticipated update to ICH. A key theme is the TMF's function in demonstrating data integrity, compliance with Good Clinical Practice (GCP), and subject safety, which are paramount in drug development. Dorzinski illustrates the historical shift in TMF management, moving from a simple "little filing cabinet" concept based on ICH E6 documents to an "explosive" volume of content today. This expansion means that TMF contributions now come from a wide array of departments beyond just clinical operations, including safety, statistics, data management, clinical supplies, and even dedicated TMF groups. The video also discusses the evolution of regulatory expectations, specifically citing ICH E6 R2, which mandates sponsors and investigators to maintain a record of the location of their essential documents, often referred to as a TMF map or index. This regulatory requirement not only streamlines operations but also ensures a structured approach to managing critical clinical trial documentation. A practical example shared in the video describes an inspection where a well-managed TMF allowed inspectors to quickly find everything they needed, leading to a positive outcome with minimal direct interaction with sponsor personnel. This anecdote powerfully demonstrates the value of a standalone, meticulously organized TMF that clearly tells the study's story. The speaker advocates for proactive TMF management and quality control, stressing that significant effort upfront can prevent major issues during regulatory inspections, ultimately protecting the asset (the drug) and ensuring the integrity of the clinical trial process. Key Takeaways: * **TMF as the "Story of the Study":** The Trial Master File is the comprehensive narrative of a clinical trial, encompassing all essential documents that demonstrate the study's conduct, data integrity, compliance, and subject safety. It's crucial for understanding the good, the bad, and the ugly aspects of a trial. * **Sponsor's Ultimate Accountability:** Even when a CRO manages the TMF, the sponsor retains significant responsibility and accountability for its management and content. Sponsors must be prepared to speak to inspectors directly, as vendors are generally not put in that position. * **Regulatory Imperative:** The TMF is a regulatory requirement referenced in protocol regulations, EU directives, and ICH guidelines (e.g., ICH E6 R2). It serves as the primary evidence for health authorities like the FDA, EMA, and MHRA, who often refer to it as the "cornerstone of inspection." * **"If You Didn't Document It, You Didn't Do It":** This fundamental principle underscores the necessity of thorough and accurate documentation. Without documented evidence in the TMF, claims of actions taken during a clinical trial are not accepted by inspectors. * **Evolution of TMF Content and Contributors:** The TMF has evolved from a small collection of ICH E6 documents to an "explosive" volume of content. Contributions now come from diverse departments including safety, statistics, data management, clinical supplies, R&D, and even dedicated TMF groups, requiring a collaborative approach. * **Importance of a TMF Map/Index:** ICH E6 R2 mandates sponsors and investigators to maintain a record of the location of their essential documents. Creating a TMF map or index is not just a best practice but a regulatory requirement that facilitates efficient management and inspection readiness. * **Inspection Readiness and Asset Protection:** A well-managed, standalone TMF allows inspectors to find information efficiently, minimizing the need for extensive interviews and demonstrating robust study conduct. This proactive approach protects the sponsor's asset (the drug) by providing clear evidence of how the study was managed. * **Ongoing TMF Management and Quality Control:** Continuous management and quality control are essential for maintaining an inspection-ready TMF. Significant upfront effort in setting up and maintaining the TMF can lead to smoother inspections and prevent compliance issues. * **Essential Documents Defined:** Per ICH, essential documents are those that permit evaluation of the conduct of the study, the quality of the data, compliance with GCP, and all applicable regulatory requirements. The TMF is the repository for these critical documents. Key Concepts: * **Trial Master File (TMF):** A collection of essential documents that individually and collectively permit the evaluation of the conduct of a clinical trial and the quality of the data produced. It serves to demonstrate the compliance of the investigator, sponsor, and monitor with the standards of Good Clinical Practice and all applicable regulatory requirements. * **ICH E6 R2:** An addendum to the International Conference on Harmonisation (ICH) guideline for Good Clinical Practice (GCP), which provides updated guidance on the management of clinical trials, including specific requirements for TMF management and the need for a record of document locations. * **TMF Reference Model:** A standardized, hierarchical model for organizing and classifying TMF documents, designed to promote consistency and efficiency in TMF management across the industry. * **Good Clinical Practice (GCP):** An international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects. Compliance with GCP is a core function of the TMF. Examples/Case Studies: * **Infection Preparation Study:** The speaker recounts a real-world example of an infection preparation study involving three TMFs, each with a thousand documents. After nine months of intensive work with a CRO and sites to gather content, an inspector reviewed the TMF for three days. The inspector concluded, "Your TMF is awesome; I can find everything I'm looking for. It clearly tells the story of your study," demonstrating that a well-prepared TMF can significantly streamline inspections and lead to positive outcomes.

2.0K views

34.7

Top 10 TMF Specialist Interview Questions||Trial Master File||TMF||Clinical Research

9:24

Health Insurance PPOs, HMOs, CDHPs Explained... Learn Price-Transparency and Other Tricks

AHealthcareZ - Healthcare Finance Explained

@ahealthcarez

Dec 7, 2021

This video provides an in-depth exploration of health insurance plan designs and the critical concept of price transparency within the U.S. healthcare system. Dr. Eric Bricker begins by demystifying the fundamental components of any insurance policy—premium, payout, and fine print—before diving into the specific structures of Preferred Provider Organizations (PPOs), Point of Service (POS) plans, Health Maintenance Organizations (HMOs), and Consumer Directed Health Plans (CDHPs). The presentation is structured to educate viewers on how each plan type dictates patient access to care, cost-sharing mechanisms like deductibles, co-pays, co-insurance, and out-of-pocket maximums, and the often-confusing nuances of in-network versus out-of-network benefits. A significant portion of the video is dedicated to explaining the mechanics of each plan, using practical examples to illustrate how costs are calculated for individuals and families, including the complexities of embedded deductibles and accumulators. Dr. Bricker highlights the trade-offs inherent in different plan designs, such as the flexibility of PPOs versus the cost-effectiveness but restrictiveness of HMOs with their Primary Care Physician (PCP) gatekeepers. He also details the unique features of CDHPs, which aim to make consumers more price-sensitive by eliminating co-pays and incorporating Health Savings Accounts (HSAs) or Health Reimbursement Arrangements (HRAs) as funding mechanisms for high deductibles, with HSAs offering significant long-term savings and tax advantages. The latter part of the video shifts focus to the crucial topic of price transparency, revealing the dramatic variability in "allowed amounts" for the same medical services, even among in-network providers in the same geographic area. Dr. Bricker provides compelling examples, such as a 4x difference in MRI costs or orthopedic surgery prices between two local hospitals, underscoring the importance of shopping for "shoppable services" like imaging, lab tests, and elective procedures. He warns against common pitfalls, such as hospital-owned imaging centers charging higher rates, and introduces Reference-Based Pricing (RBP) as an alternative model for self-funded employers seeking to reduce costs by paying providers a multiple of Medicare reimbursement, albeit with potential risks like balance billing for patients. The overall approach is educational, aiming to empower consumers and employers with the knowledge to navigate the complex financial landscape of healthcare. Key Takeaways: * **Three Core Insurance Components:** All health insurance policies, like other insurance types, consist of three parts: the premium (monthly payment), the payout (how claims are reimbursed, defining the plan design), and the fine print (specific exclusions and details). * **PPO Plan Mechanics:** Preferred Provider Organizations (PPOs) offer distinct in-network and out-of-network benefits, each with separate deductibles, co-insurance rates, and out-of-pocket maximums. Co-pays for doctor visits are typically fixed, while co-insurance applies after the deductible for other services. * **Embedded Deductibles in PPOs:** For family plans, PPOs often have "embedded deductibles," meaning two individuals must meet their individual deductible and out-of-pocket maximums before the family's overall maximum is considered met, rather than one person reaching a higher family aggregate. * **Co-pays Excluded from Out-of-Pocket Max:** A common misconception is that co-pays count towards the out-of-pocket maximum. In PPO and CDHP plans, co-pays are typically owed even after the out-of-pocket maximum is met, designed to discourage excessive utilization once costs are otherwise fully covered. * **POS Plan Limitations:** Point of Service (POS) plans are similar to PPOs but generally offer no out-of-network coverage except for "real emergencies," which are defined by the insurance company, not the patient, leading to potential claim denials for perceived non-emergencies. * **HMO Gatekeeper Model:** Health Maintenance Organizations (HMOs) mandate a Primary Care Physician (PCP) gatekeeper who must provide referrals for all specialist visits, tests, and procedures. This model offers lower out-of-pocket costs but significantly restricts patient choice and requires strict adherence to referral protocols. * **CDHP Design and Consumer Awareness:** Consumer Directed Health Plans (CDHPs) feature high deductibles and typically no co-pays, aiming to make consumers more aware of healthcare costs. After the deductible, co-insurance applies until the out-of-pocket maximum is reached. * **Health Savings Accounts (HSAs) vs. Health Reimbursement Arrangements (HRAs):** CDHPs often include special accounts. HSAs are employee-owned, portable, tax-free for medical expenses, and can be used as a retirement savings vehicle. HRAs are employer-owned, non-portable, and funds are lost if the employee leaves the company. * **Dramatic Price Variability (Price Transparency):** Even for in-network services, the "allowed amount" (the true price after insurance discounts) can vary by 400% or more for the same service in the same local area, depending on the specific doctor or hospital. * **Importance of Shopping for Shoppable Services:** For elective and scheduled procedures (e.g., imaging, lab tests, colonoscopies, orthopedic surgeries), patients with PPO, POS, or CDHP plans can save significant money by comparing prices among different facilities. * **Beware of Hospital-Owned Facilities:** Independent imaging centers and ambulatory surgery centers are often much less expensive than hospitals. However, many ostensibly independent facilities are owned by hospitals and charge higher hospital rates, requiring careful investigation by patients. * **Reference-Based Pricing (RBP) for Self-Funded Plans:** RBP is an alternative model where employers pay providers a multiple of Medicare reimbursement (e.g., 150-250%) instead of relying on traditional networks. This can lead to substantial savings but carries the risk of "balance billing" where providers bill the patient for the difference between their charge and the RBP payment. * **The Role of Accumulators:** Insurance companies use "accumulators" (software) to track how much an individual or family has paid towards their deductible and out-of-pocket maximums, which typically reset annually. **Key Concepts:** * **PPO (Preferred Provider Organization):** A health plan that offers a network of providers, allowing patients to choose providers both in-network and out-of-network, with higher costs for out-of-network care. * **HMO (Health Maintenance Organization):** A health plan that requires patients to select a primary care physician (PCP) who acts as a "gatekeeper" for referrals to specialists and other services, offering lower costs but less choice. * **POS (Point of Service):** A hybrid health plan that combines elements of both HMOs and PPOs, offering in-network benefits like an HMO but allowing out-of-network care (often with no coverage) like a PPO. * **CDHP (Consumer Directed Health Plan):** High-deductible health plans designed to engage consumers in healthcare spending decisions, often paired with HSAs or HRAs. * **HSA (Health Savings Account):** A tax-advantaged savings account that can be used for qualified medical expenses, available only with high-deductible health plans. * **HRA (Health Reimbursement Arrangement):** An employer-funded account that reimburses employees for qualified medical expenses, typically not portable if the employee leaves the company. * **Deductible:** The amount an insured person must pay out-of-pocket before their health insurance plan begins to pay for covered medical expenses. * **Co-pay:** A fixed amount an insured person pays for a covered healthcare service at the time of service. * **Co-insurance:** The percentage of costs an insured person pays for a covered healthcare service after they've met their deductible. * **Out-of-pocket Max:** The maximum amount an insured person has to pay for covered services in a plan year; after this limit, the insurance plan pays 100% of covered costs. * **Embedded Deductible:** A feature in family health plans where each individual in the family has an individual deductible that must be met before the family deductible is satisfied. * **Accumulator:** The system or process used by insurance companies to track a member's progress towards meeting their deductible and out-of-pocket maximums. * **Allowed Amount:** The maximum amount an insurance plan will pay for a covered healthcare service. This is the "true price" after negotiated discounts. * **Reference-Based Pricing (RBP):** A healthcare payment model where the amount paid to providers for services is based on a reference price, often a multiple of Medicare reimbursement rates, rather than negotiated network rates. * **Balance Billing:** When a healthcare provider bills a patient for the difference between the provider's charge and the amount the insurance company (or RBP plan) pays. **Examples/Case Studies:** * **MRI Cost Variation:** An MRI might have billed charges of $4,000, discounted to an allowed amount of $2,000 by a PPO. However, the same MRI at a different in-network hospital could have an allowed amount of only $500, demonstrating a 4x price difference. * **Orthopedic Surgery Cost Variation:** An arthroscopic knee surgery might have an allowed amount of $4,000 at one hospital, but $16,000 at another, highlighting a 4x difference for a specific procedure. * **Colonoscopy Facility Fees:** A colonoscopy performed at a hospital might cost $4,000, while the same procedure performed by the same gastroenterologist at an independent endoscopy center could cost only $800. * **Lab Test Cost Variation:** Getting blood drawn at a hospital can be four to five times more expensive than getting the same lab tests done at an independent lab facility. * **HMO Examples:** The Kaiser Health System in California and Harvard Pilgrim Health System in New England are cited as prominent examples of HMO models. * **Price Transparency Navigation:** The speaker mentions his prior company, Compass, which helped people navigate and find these price differences before transparency laws were enacted. * **Reference-Based Pricing TPA:** GPA in Dallas is given as an example of a Third-Party Administrator (TPA) that offers reference-based pricing plans for self-funded employers.

71.7K views

38.1

2:55

The Insane Cost of Diabetes on Healthcare Spend

Self-Funded

@SelfFunded

Dec 7, 2021

This video provides an in-depth exploration of the escalating financial burden of diabetes on healthcare spending, particularly from the perspective of employers managing insurance costs. The discussion, featuring Preston Pomykal, highlights that while medical inflation (or "trend") is a factor, the dramatic increase in disease prevalence—specifically diabetes—is the primary driver behind the skyrocketing costs. The speaker emphasizes that traditional cost-containment strategies, such as reference-based pricing or contractual language adjustments, offer only a temporary "bite of the apple" and do not address the root cause of the problem. The core of the discussion revolves around a stark comparison of diabetes statistics over the past 25 years. The speaker, drawing on his experience as an underwriter, illustrates how the average diabetic rate in an insured population has quadrupled, moving from an estimated 3-4% a quarter-century ago to 12-13% today. This trend is projected to continue, potentially reaching 20% by 2025. Concurrently, the average annual cost per diabetic has more than doubled, from approximately $10,000 to $21,000. Through a simple yet powerful calculation, the speaker demonstrates the combined effect of increased prevalence and medical inflation. For a hypothetical group of 100 people, the cost associated with diabetes has surged from $30,000 (3 diabetics at $10,000 each) 25 years ago to an astounding $252,000 today (12 diabetics at $21,000 each). This represents an eight-fold increase in costs, primarily driven by the four-fold increase in disease prevalence. The central argument presented is that while everyone focuses on "trend, trend, trend" and medical inflation, the more critical and impactful strategy for employers and the healthcare system at large is to "produce less disease." This paradigm shift from managing costs to preventing illness is presented as the ultimate solution for achieving sustainable healthcare savings and improving population health. Key Takeaways: * **Diabetes Prevalence is a Primary Cost Driver:** The video strongly argues that the dramatic increase in diabetes prevalence, rather than just medical inflation, is the leading cause of escalating healthcare costs for employers. * **Historical vs. Current Prevalence:** Approximately 25 years ago, the average diabetic rate in an insured population was 3-4%; today, it stands at 12-13%. This represents a significant quadrupling of the affected population. * **Projected Future Prevalence:** Experts project that the diabetic rate could reach 20% by 2025, indicating a worsening trend that will further exacerbate healthcare spending. * **Combined Impact of Prevalence and Inflation:** While the cost per diabetic has doubled from $10,000 to $21,000 over 25 years, the four-fold increase in prevalence means the total cost for a group of 100 people has increased eight-fold (from $30,000 to $252,000). * **Limitations of Traditional Cost Containment:** Strategies like reference-based pricing and adjusting contractual language offer only marginal, short-term savings and do not address the underlying issue of increasing disease burden. * **Focus on "Affecting Risk":** Employers, especially small groups pooling resources, must shift their focus from merely managing insurance costs to actively "affecting risk" within their employee population, meaning reducing the incidence of chronic diseases. * **The Overlooked Factor of "Utilization":** The speaker highlights that while medical inflation ("trend") is often emphasized, the "utilization" of healthcare services due to increased disease prevalence is the more impactful and often overlooked factor driving costs. * **Strategic Shift to Disease Prevention:** The ultimate and most effective strategy for sustainable healthcare cost reduction is to "produce less disease." This implies a move towards preventative health, wellness programs, and interventions that reduce the incidence of chronic conditions like diabetes. * **Employer Ecstasy through Disease Reduction:** The video concludes that if the healthcare system and employers could collectively reduce the prevalence of diseases, it would lead to significant financial relief and positive outcomes for all stakeholders. * **Implications for Life Sciences:** The insights underscore the critical need for pharmaceutical and biotech companies to develop not only effective treatments but also preventative solutions and data-driven approaches that can help manage and ultimately reduce disease prevalence within populations. Key Concepts: * **Trend (Medical Inflation):** Refers to the increase in the cost of medical services and goods over time. * **Utilization:** Pertains to the frequency and extent to which healthcare services are used, often directly correlated with the prevalence of disease within a population. * **Affecting Risk:** A strategic approach focused on reducing the health risks within a population, thereby decreasing the likelihood of costly medical conditions.

80 views

31.6

35:01

Health Insurance Industry Explained--Health Insurance from Job (Employer-Sponsored)

AHealthcareZ - Healthcare Finance Explained

@ahealthcarez

Dec 4, 2021

This video provides an in-depth exploration of employer-sponsored health plans, dissecting the complex financial and administrative structures that underpin healthcare coverage for a significant portion of the American workforce. Dr. Eric Bricker, the speaker, systematically breaks down the four core constituents of these plans—employers, employees, insurance carriers/PBMs, and providers/pharmacies—illustrating their intricate interdependencies and the flow of money and services among them. The presentation progresses from foundational concepts to more nuanced aspects, including different risk-transfer models, network discount methodologies, medical coding standards, administrative service options, and the dynamics of health insurance captives. The speaker's approach is highly educational, using clear analogies and specific examples to demystify complex industry jargon. He begins by outlining the basic transactional relationships, such as premium payments from employers to insurers, out-of-pocket costs from employees to providers, and claim adjudication by insurers. He then delves into the critical distinction between fully-insured and self-insured plans, explaining how risk is borne and the financial implications for employers, particularly those with over 200 employees who often opt for self-insurance. This segment highlights the concept of the medical loss ratio (MLR) and the necessity of stop-loss insurance to protect self-funded employers from catastrophic individual or aggregate claims. Further segments elaborate on the mechanics of network discounts, detailing various repricing methodologies like percent of charge, fixed case rates, per diems, and carve-outs, using examples such as gallbladder surgery and hip replacements to illustrate their application. The video also provides a comprehensive overview of medical coding, explaining the purpose and structure of UB04s, HCFA 1500s, ICD-10, CPT, DRG, and HCPCS/J-codes. The discussion then shifts to administrative services, differentiating between Administrative Services Only (ASO) provided by major carriers (BUCA) and Third-Party Administrators (TPAs), outlining their cost structures and flexibility. The final section introduces health insurance captives, explaining how small employers can pool risk for better rates, while also cautioning about the risks of adverse selection and the "death spiral" in fully-insured captive models. Key Takeaways: * **Four Core Constituents of Employer-Sponsored Health Plans:** The system involves employers (providing coverage, paying premiums), employees (receiving care, paying out-of-pocket and payroll deductions), insurance carriers/PBMs (adjudicating claims, managing networks, receiving premiums), and providers/pharmacies (delivering care, filing claims, receiving payments). * **Fully-Insured vs. Self-Insured Models:** In fully-insured plans, the insurance company bears all the risk, while in self-insured plans, the employer retains the financial risk, directly paying claims from their own funds (often via the insurer as an administrator). Most companies with over 200 employees tend to be self-insured. * **Medical Loss Ratio (MLR):** Insurance companies in fully-insured plans typically aim for an MLR of around 85%, meaning 85% of premiums go to claims and 15% is kept for administrative costs and profit. This ratio influences future premium adjustments for employers. * **Stop-Loss Insurance for Self-Funded Employers:** To mitigate the risk of extremely high claims, self-funded employers purchase stop-loss insurance. Specific stop-loss covers individual catastrophic claims (e.g., above $100,000 per person), while aggregate stop-loss covers the entire group if total claims exceed a predetermined threshold. * **Network Discounts and Repricing Methodologies:** Insurance companies negotiate discounts with providers. Repricing methods include percent of charge (e.g., 40% off billed charges), fixed case rates (e.g., $2,000 for an MRI regardless of billed amount), per diems (e.g., $3,000 per day for inpatient stays), and carve-outs (separate reimbursement for specific high-cost items like implants). * **Medical Coding Standards:** Healthcare bills use specific codes for diagnoses (ICD-10), procedures (CPT, including E&M codes for office visits), inpatient services (DRG), and additional items like medications or implants (HCPCS/J-codes). Understanding these codes is crucial for claims processing and data analysis. * **Administrative Services Only (ASO) vs. Third-Party Administrators (TPA):** ASOs are services provided by major insurance carriers (Blue Cross, United, Cigna, Aetna) for self-funded employers, handling claims adjudication and network access. TPAs are independent or carrier-owned entities offering similar administrative services, often at a lower cost but with potentially less comprehensive support or requiring employers to "rent" networks separately. * **Health Insurance Captives:** These are pooled groups of small employers who band together to gain leverage for better insurance rates, often by self-funding collectively. While offering potential cost savings, fully-insured captives are susceptible to adverse selection, where sicker groups join, driving up costs and leading healthier groups to leave, potentially causing a "death spiral." Self-funded captives are generally more stable. * **Financial Scale of Employer-Sponsored Health Plans:** On average, health insurance premiums cost about $10,000 per employee per year, with roughly two plan members per subscriber. A company with 100 subscribers could pay $1 million annually in premiums. * **Credibility in Premium Setting:** For fully-insured plans, premiums can be community-rated (based on regional risk for small groups), partially credible (partially based on the employer's own claims experience), or fully credible (entirely based on the employer's claims for larger groups, typically over 500 employees). Key Concepts: * **Fully-Insured:** An insurance model where the insurance company assumes all financial risk for claims. * **Self-Insured:** An insurance model where the employer assumes the financial risk for employee health claims, often using an insurer for administrative services only. * **Risk, Adjudication, Network:** The three core components of any insurance policy; risk refers to who pays for claims, adjudication is the processing and payment of claims, and the network is the group of contracted providers. * **Medical Loss Ratio (MLR):** The percentage of premium revenue that an insurer spends on medical care and quality improvement. * **Stop-Loss Insurance:** Reinsurance purchased by self-funded employers to protect against high-cost claims. * **Specific Stop-Loss:** Covers claims exceeding a set amount for an individual. * **Aggregate Stop-Loss:** Covers total claims for the entire group exceeding a set amount. * **Repricing Methodologies:** Various contractual agreements between insurers and providers to determine the allowed amount for services after discounts. * **Percent of Charge:** A fixed percentage discount off the provider's billed charges. * **Fixed Case Rate:** A predetermined payment for a specific service or procedure, regardless of billed charges. * **Per Diem:** A daily rate paid for inpatient hospital stays. * **Carve-Out:** Separate reimbursement for specific high-cost items, often implants or specialized medications. * **Medical Coding:** Standardized alphanumeric codes used to describe diagnoses and procedures for billing and record-keeping. * **ICD-10:** International Classification of Diseases, 10th Revision (diagnosis codes). * **CPT:** Current Procedural Terminology (procedure codes, including E&M for office visits). * **DRG:** Diagnosis Related Groups (used for inpatient services). * **HCPCS (J-codes):** Healthcare Common Procedure Coding System (additional codes, often for medications or specific supplies). * **Administrative Services Only (ASO):** Services provided by major insurance carriers to self-funded employers for claims processing and network access, without assuming risk. * **Third Party Administrator (TPA):** An organization that processes insurance claims or certain aspects of employee benefit plans for a separate entity, often for self-funded employers. * **Health Insurance Captives:** Groups of employers that pool their resources to self-insure, often to achieve better rates and more control over their health plans. * **Adverse Selection:** The tendency for individuals with higher health risks to disproportionately seek out and utilize insurance coverage. * **Death Spiral:** A phenomenon where adverse selection leads to increasing premiums, causing healthier individuals to leave the plan, further increasing premiums and eventually leading to the plan's collapse. Examples/Case Studies: * **Repricing Example (Gallbladder Surgery):** A $10,000 billed charge, with a 40% discount, results in a $6,000 allowed amount paid to the hospital. * **Carve-Out Example (Hip Replacement):** A $100,000 billed charge for a hip replacement with a three-day stay might include a $3,000 per diem for the stay ($9,000 total) and a $30,000 carve-out for the implant, totaling $39,000 in reimbursement. * **Catastrophic Claims:** Examples like a premature baby in the NICU or a skiing accident leading to an ICU stay illustrate individual claims that can exceed $1 million, necessitating specific stop-loss insurance. * **TPA Examples:** UMR (owned by UnitedHealthcare) and Meritain (owned by Aetna) are examples of carrier-owned TPAs that offer more flexible, lower-cost administrative services compared to their parent companies' ASO offerings. Independent TPAs like GPA Group and Pension Administrators or Web TPA also exist, often renting networks from major carriers like Cigna or Aetna. * **Reinsurance Companies:** Sun Life, QBE, and Tokyo Marine are mentioned as examples of companies that provide stop-loss insurance. * **Self-Funded Captive Examples:** Roundstone and Pareto are cited as prominent examples of self-funded captive models.

35.4K views

37.9

15:02

Industry Insights: Veeva Systems (AY: '21-'22; EP: 1)

Hire Lehigh

/@HireLehigh

Dec 3, 2021

This video provides an in-depth interview with Kristina Gonzalez Medina, a Practice Director within the Analytics Development Program at Veeva Systems, conducted by Lehigh University's Career Professional Development team. The primary purpose of the discussion is to offer "Industry Insights" into Veeva Systems, a Public Benefit Corporation specializing in cloud computing software for the life sciences industry. Kristina elaborates on Veeva's core mission, the skills and competencies they seek in prospective candidates, and the company's robust approach to employee development, diversity, equity, and inclusion (DEI), and feedback mechanisms. The conversation also delves into practical advice for new hires on navigating workplace challenges and connecting with the company. The interview progresses from an introduction to Veeva Systems, highlighting its focus on building an "industry cloud for life sciences" through data, technology, analytics, and professional services. Kristina then outlines the essential skills Veeva looks for, emphasizing teamwork, hard work, fast learning, problem-solving, analytical thinking, and a balance of technical and soft skills. A significant portion of the discussion is dedicated to what makes an employee stand out, stressing the importance of curiosity, continuous learning, and taking ownership of one's development, encapsulated by the phrase "captain your own ship." This is supported by a unique "2% development reimbursement" program, allowing employees to invest in their personal and professional growth through various means like coaching, conferences, or books. Further themes explored include Veeva's commitment to DEI, spearheaded by a Chief Diversity Officer and various internal communities (e.g., women's, black, Asian, LGBTQ+ communities) that focus on education, recruiting, and internal connection. Kristina underscores the value of diverse perspectives for innovation, particularly for a global company like Veeva. The video also details Veeva's employee feedback systems, including a new check-in process for open dialogue between managers and employees, and anonymous channels, even direct email access to the CEO, Peter Gassner. A compelling example is shared where anonymous feedback led to the establishment of "Employee Success" as a core company value and the subsequent launch of employee growth benefits like the development reimbursement program. The interview concludes with advice for new hires on managing conflict through preparation, building internal relationships, and seeking mentorship, alongside practical tips for students to connect with Veeva and approach their job search thoughtfully. Key Takeaways: * **Veeva's Core Mission:** Veeva Systems is dedicated to building the "industry cloud for life sciences," encompassing data, technology, analytics, and professional services tailored for the pharmaceutical and biotech sectors. This positions them as a critical technology partner within IntuitionLabs.ai's target market. * **Desired Candidate Skills:** Veeva prioritizes candidates who exhibit strong teamwork, a diligent work ethic, quick learning abilities, problem-solving aptitude, analytical thinking, and a balanced blend of technical and interpersonal communication skills. * **Importance of Curiosity and Ownership:** To excel at Veeva, employees are encouraged to be continuously curious, seeking to understand the "why" behind their tasks, and to take ownership of their professional development, a concept referred to as "captain your own ship." * **Employee Development Reimbursement:** Veeva offers a unique "2% development reimbursement" program, allowing employees to invest in their growth through various avenues like career coaching, conferences, subscriptions, or books, fostering a culture of continuous learning. * **Robust DEI Initiatives:** The company actively promotes diversity, equity, and inclusion through a Chief Diversity Officer, dedicated internal communities (e.g., women's, black, Asian, LGBTQ+), bias training in hiring, and a commitment to equitable processes. * **Value of Diverse Perspectives:** Kristina emphasizes that collaboration among diverse perspectives is crucial for innovation and driving the company's mission forward, especially for a global organization with teams across many countries. * **Multi-Channel Employee Feedback System:** Veeva employs a comprehensive feedback system, including open dialogue check-ins between managers and employees, anonymous submission channels, and even direct anonymous email access to the CEO, demonstrating a strong commitment to listening to its workforce. * **Impact of Employee Feedback:** Employee feedback has directly influenced significant company policies and values, such as the CEO establishing "Employee Success" as a core value and initiating programs like the 2% development reimbursement in response to direct employee input. * **Navigating Workplace Conflict:** New hires are advised to prepare for difficult conversations, build internal relationships with peers and mentors for support and advice, and acknowledge that speaking up requires practice and comfort, emphasizing that raising issues is vital for collective progress. * **Importance of Support Systems:** Building a network of colleagues, especially through internal communities, can provide a crucial support system, fostering a sense of belonging and enabling employees to address challenges more effectively. * **Strategic Job Search Advice:** Students are encouraged to "interview the company" as much as they are being interviewed, thoughtfully considering what is important to them (e.g., work-life balance, societal impact, specific tasks) to ensure long-term success and happiness in their chosen role. Tools/Resources Mentioned: * **Veeva's Blogs:** A source for company information and insights. * **Veeva's YouTube Channel:** Provides video content about the company. * **Generation Veeva LinkedIn Page:** Specifically for new grads and opportunities within Veeva. * **Sarah Shields ([email protected]):** Veeva's university recruiter, available for questions and guidance on the application process. Key Concepts: * **Industry Cloud for Life Sciences:** Veeva's core business model, providing specialized cloud computing software solutions tailored specifically for the pharmaceutical, biotech, and life sciences industries. * **Generation Veeva Program:** A broader initiative focused on recruiting and integrating new graduates into various parts of the company. * **Analytics Development Program:** A specific program within Generation Veeva, likely focusing on developing analytical talent for Veeva's data and analytics offerings. * **Captain Your Own Ship:** A cultural value at Veeva, encouraging employees to take proactive ownership of their career development and continuous learning. * **2% Development Reimbursement:** A unique employee benefit where Veeva reimburses up to 2% of an employee's salary for approved professional development activities. * **Employee Success (as a core value):** A fundamental principle at Veeva, established in response to employee feedback, signifying the company's commitment to investing in the growth and well-being of its employees. Examples/Case Studies: * **Personal Use of Development Reimbursement:** Kristina shared her personal experience of using the 2% development reimbursement to hire a leadership coach, highlighting the flexibility and personalized nature of the program. * **CEO's Response to Anonymous Feedback:** Peter Gassner, Veeva's CEO, received an anonymous email from an employee questioning the company's investment in "Employee Success" despite it being a stated value. This feedback directly led to significant investments in employee growth, including the creation of the 2% development program and a stronger emphasis on employee well-being.

63 views

38.2

29:01

RegTalks about Regulatory Information Management Systems (RIMS)

Asphalion

/@Asphalion.

Nov 29, 2021

This RegTalks episode, featuring Lidia Canovas of Asphalion and Udo Griem of Körber Pharma Software, provides an in-depth discussion on Regulatory Information Management Systems (RIMS) within the pharmaceutical and biotech industries. The speakers emphasize the critical role of RIMS in managing medicinal product data, particularly in anticipation of the complex transition to ISO IDMP standards. Griem defines RIMS through three core pillars: a solid, data-oriented database serving as a single source of truth for product master data, a robust workflow engine to manage submissions and approval processes, and capabilities for structured data submissions to authorities. He advocates for a data-oriented approach over traditional document-driven methods to ensure data quality and consistency. Key drivers for RIMS implementation include the impending IDMP mandate, the industry's shift towards structured data, competitive pressures for faster time-to-market, and the need for organizational process optimization. RIMS are shown to be beneficial for companies of all sizes and product portfolios, fostering a culture of quality and improving cross-departmental collaboration. While regulatory affairs is the primary user, RIMS serve as a central hub, supporting cross-functional processes across clinical, ERP, safety/pharmacovigilance, MES, and label artwork management. A significant emerging trend highlighted is the connection of RIMS data to data lakes for future evaluation with artificial intelligence. The discussion also underscores the importance of experienced implementation partners who can bridge the gap between software solutions and organizational needs, ensuring successful deployment and continuous improvement. Körber's AI Manager RIMS aims to minimize compliance risks, enhance efficiency, enable teamwork, and reduce costs, with IDMP compliance being a high priority in its development roadmap. **Key Takeaways:** * **RIMS are Foundational for Regulatory Compliance and Efficiency:** RIMS are critical for managing complex regulatory data, streamlining submissions, and ensuring compliance with evolving standards like IDMP, which is rapidly approaching and will significantly increase data complexity. * **Data-Oriented Approach is Paramount for RIMS:** A consistent, data-oriented design with a well-organized database is considered superior to document-driven approaches, ensuring high data quality, consistency, and adaptability for future regulatory requirements. * **RIMS Drive Cross-Functional Integration and Quality Culture:** Beyond regulatory affairs, RIMS act as a central hub, connecting and supporting various departments (e.g., clinical, ERP, safety, MES, QA) to improve collaboration, reduce error rates, and shorten response times across the pharmaceutical value chain. * **AI Integration is an Emerging Trend for RIMS Data:** There is a growing focus on connecting RIMS data to data lakes, specifically for evaluation with artificial intelligence, indicating a future direction for leveraging regulatory information for advanced insights and automation. * **Implementation Partners are Crucial for Successful RIMS Adoption:** Experienced partners with deep regulatory and product knowledge are vital for guiding companies through organizational and process changes, customizing solutions, and ensuring successful integration and continuous improvement. * **RIMS Benefits Extend to All Company Sizes and Diverse Portfolios:** While historically adopted by large multinationals, RIMS are now essential for small and mid-tier firms, including startups, to effectively build and scale regulatory organizations and manage diverse product portfolios beyond human medicine.

396 views

46.5

38:34

40+ Doctor Specialties Explained: Master Class on How Physician Sub-Specialization Works

AHealthcareZ - Healthcare Finance Explained

@ahealthcarez

Nov 28, 2021

This video provides an in-depth exploration of physician specialties and sub-specialties, detailing their training pathways, scope of practice, and the common conditions they diagnose and treat. Dr. Eric Bricker, an internal medicine physician, systematically breaks down the complex landscape of medical specialization, emphasizing its critical importance for anyone working within the healthcare ecosystem. The presentation begins by outlining the rigorous journey of becoming a doctor, from medical school (MD vs. DO) through residency, state licensure, board certification, and optional fellowship training, which can extend for many years. The core of the video categorizes physician specialties into four main groups: Primary Care Physicians, Internal Medicine Sub-specialties, Surgical Specialties, and a broad "Other" category. For each specialty, Dr. Bricker explains its focus, typical procedures or treatments, and specific medical conditions addressed. For instance, he details how cardiologists manage coronary artery disease, valvular issues, and arrhythmias, while pulmonologists handle lung diseases like asthma and COPD, and also serve as ICU and sleep apnea experts. The discussion highlights the distinction between medical and surgical approaches, such as medical oncologists administering chemotherapy versus surgical oncologists performing tumor removal, and the frequent overlap and "turf wars" between specialties, particularly in areas like spine surgery or cancer treatment. The video further delves into the nuances of sub-specialization, illustrating how many internal medicine physicians pursue fellowships in areas like gastroenterology or endocrinology. It also touches on sub-sub-specialties within fields like OB/GYN (e.g., Maternal Fetal Medicine for high-risk pregnancies, Reproductive Endocrinology for fertility) and Orthopedics (e.g., spine, foot, hand specialists). The speaker's approach is highly educational and practical, providing a foundational understanding of who does what in medicine, which is invaluable for professionals in related industries such as pharmaceuticals, medical devices, and healthcare administration, who need to navigate and engage with diverse medical communities. Key Takeaways: * **Comprehensive Physician Training:** Becoming a physician involves medical school (MD or DO), a residency program (3-9 years, e.g., internal medicine is 3 years, neurosurgery is 9 years), state licensure, and optional board certification (a private designation requiring extensive testing). Many physicians further sub-specialize through fellowships (additional 2-4 years). * **Primary Care Physician (PCP) Categories:** PCPs include pediatricians (kids), general internal medicine physicians (adults), and family practice physicians (all ages). OB/GYNs are typically considered specialists for insurance purposes, despite some women viewing them as their primary care provider. * **Internal Medicine Sub-specialties Focus:** These physicians treat internal organ diseases non-surgically. Examples include Cardiologists (heart conditions like heart attacks, valvular disease, arrhythmias), Pulmonologists (lung diseases, ICU care, sleep apnea), Gastroenterologists (digestive tract, liver, colonoscopies, EGDS), Hematology/Oncology (blood and cancer, chemotherapy administration), and Endocrinologists (hormone and gland disorders like thyroid dysfunction, diabetes, adrenal issues). * **Autoimmune Disease Expertise:** Rheumatologists specialize in autoimmune conditions where the immune system attacks the body, such as rheumatoid arthritis, psoriatic arthritis, lupus, and fibromyalgia. Neurologists also treat autoimmune diseases affecting the nervous system, like multiple sclerosis. * **Infectious Disease Management:** Infectious disease doctors handle severe or chronic infections, including HIV/AIDS, pyelonephritis, cellulitis, fungal infections, and complex infections in immune-compromised patients. * **Allergy Specialization:** Allergists focus on diagnosing specific allergies through testing and providing desensitization therapy (allergy shots) to build tolerance. * **Diverse Surgical Fields:** Surgical specialties range from General Surgery (hernias, gallbladders, appendicitis) to highly specialized areas like Cardiothoracic Surgery (heart/lung, CABG), Vascular Surgery (blood vessels, PVD, aortic aneurysms), Trauma Surgery (gunshot wounds, car accidents), and Surgical Oncology (tumor removal, often overlapping with other surgeons). * **"Other" Key Specialties:** This broad category includes OB/GYN (obstetrics and gynecology, also surgeons for hysterectomies/ovarian cysts), Orthopedic Surgeons (bones/joints, total joint replacements, spine), Neurosurgeons (brain/spine surgery), ENT (ear, nose, throat, sinus surgery, ear tubes), Urologists (kidney, bladder, prostate cancer surgery), Neurologists (medical brain/spinal cord conditions like seizures, MS, dementia), Anesthesiologists (sedation, pain management), Emergency Medicine (ER care), Radiologists (interpreting medical images), Psychiatrists (mental health, medication prescription), Dermatologists (skin conditions, cancer screening), Pathologists (lab-based tissue diagnosis for cancer), and Radiation Oncologists (radiation therapy for cancer). * **Sub-Sub-Specialization:** Many specialties have further sub-specializations, such as within OB/GYN (Gynecologic Oncology, Maternal Fetal Medicine for high-risk pregnancies, Reproductive Endocrinology for fertility) and Orthopedics (spine, foot, hand, knee/hip, arm/shoulder specialists). * **Relevance for Healthcare Industry Professionals:** A deep understanding of physician specialties and their scope of practice is fundamental for pharmaceutical and medical device companies, as it informs commercial strategies, sales force targeting, medical affairs engagement, product development, and the design of AI solutions like medical information chatbots or sales operations assistants. **Key Concepts:** * **Allopathic Medical Schools (MD):** Traditional medical schools. * **Osteopathic Medical Schools (DO):** Focus on a holistic approach, often leading to primary care. * **Residency:** Post-medical school training where physicians choose and train in a specific specialty. * **Fellowship:** Additional training after residency for sub-specialization. * **Board Certification:** A private, voluntary designation indicating expertise in a specialty, requiring rigorous examination. * **Primary Care Physician (PCP):** General medical practitioner for initial and ongoing care. * **Internal Medicine:** Specialty focused on non-surgical treatment of internal organ diseases in adults. * **Inflammatory Bowel Disease (IBD):** Autoimmune diseases of the intestines (Crohn's, ulcerative colitis). * **Irritable Bowel Syndrome (IBS):** A common functional gastrointestinal disorder, distinct from IBD. * **General Anesthesia:** Deep sedation requiring ventilator support during surgery. * **Conscious Sedation (MAC):** Lighter sedation where the patient can still breathe independently. * **Pathologist:** Physician who diagnoses diseases by examining tissues and body fluids in a lab setting. * **Radiation Oncologist:** Physician specializing in using radiation to treat cancer. * **Physiatrist (PM&R):** Physical Medicine and Rehabilitation doctor, specializing in pain management and rehabilitation. **Examples/Case Studies:** * **Cardiology:** Treatment of heart attacks, management of valvular heart disease with medication, implantation of pacemakers for arrhythmias. * **Pulmonology:** Managing asthma and COPD, overseeing patients on ventilators in the ICU, diagnosing and treating sleep apnea with CPAP. * **Gastroenterology:** Treating heartburn (GERD) and stomach ulcers, managing irritable bowel syndrome (IBS) and inflammatory bowel disease (IBD), performing screening colonoscopies and EGDS. * **Hematology/Oncology:** Administering chemotherapy for blood cancers (leukemia) and solid tumors (e.g., breast cancer). * **Endocrinology:** Managing hyper- or hypothyroidism, treating severe type 2 or type 1 diabetes, addressing adrenal gland dysfunctions. * **Rheumatology:** Treating rheumatoid arthritis, psoriatic arthritis, lupus, and fibromyalgia. * **Surgical Oncology:** Surgical removal of tumors for various cancers, often in collaboration with medical and radiation oncologists. * **Orthopedic Surgery:** Performing arthroscopic surgery for knee or shoulder issues, total knee and hip replacements, and spine surgery. * **Urology:** Surgical removal of kidney, bladder, or prostate cancers. * **Maternal Fetal Medicine:** Managing high-risk pregnancies due to conditions like maternal diabetes or preeclampsia, or issues with fetal development.

16.0K views

37.0

34:40

Healthcare Costs in America: Hospitals, Doctors, Medications and More

AHealthcareZ - Healthcare Finance Explained

@ahealthcarez

Nov 26, 2021

This video provides an in-depth exploration of the underlying causes of persistently high and rapidly rising healthcare costs in America. Dr. Bricker, the presenter, begins by establishing the alarming rate of healthcare cost inflation, which at 7% annually, triples the general inflation rate and leads to a doubling of costs every decade. He highlights the significant financial burden this places on employers and individuals, framing the discussion around the principle that one entity's increased spending translates directly into another's revenue. The presentation systematically dissects the primary drivers of these costs, focusing on hospitals, doctors, pharmaceutical companies, and medical device manufacturers, revealing the complex financial mechanisms and incentives at play within the U.S. healthcare system. The core of the video delves into how various stakeholders strategically increase their revenue, thereby escalating overall healthcare expenditures. Dr. Bricker explains the "80/20 rule" of healthcare spending, where a small percentage of patients drive the majority of costs, primarily due to conditions like musculoskeletal issues, cardiovascular disease, cancer, and complicated labor and delivery. He then breaks down cost sources, attributing 50% to hospitals, 25% to professional fees (doctors), and 20% to prescriptions. A significant portion of the analysis focuses on hospitals' cross-subsidization strategy, where they overcharge commercially insured patients and employers to offset lower payments from Medicare, Medicaid, and self-pay patients. This is further exacerbated by hospital strategies like horizontal integration (mergers to reduce competition and increase pricing power) and vertical integration (acquiring physician practices to funnel patient referrals and increase volume for their own facilities), all driven by a fee-for-service model that incentivizes more procedures rather than value or health outcomes. Further segments detail the role of private equity firms in driving up doctor fees by acquiring specific physician practices (e.g., ER, radiology, anesthesiology, pathology) and intentionally taking them out-of-network. This allows for exorbitant billing, often 10 to 20 times higher than in-network rates, directly impacting patients through high out-of-network deductibles, a practice partially addressed by the "surprise billing law" of 2022. The discussion then shifts to pharmaceutical companies, which leverage robust patent protection laws to maintain high drug prices far longer than initially intended. This is achieved through "patent thickets" (filing dozens of patents on a single drug) and "pay-to-delay" schemes, where brand-name manufacturers pay generic companies not to introduce cheaper alternatives. Additionally, pharmaceutical companies indirectly incentivize doctors through speaker fees, consulting arrangements, and providing free catered meals to practices. Finally, the video exposes the extreme markups in the medical device industry, illustrating how a device costing $300 to manufacture can be sold to a hospital for $3,000, which then bills commercial insurers $30,000, resulting in a 100-fold increase from production cost to final charge. Key Takeaways: * **Unsustainable Cost Growth:** U.S. healthcare costs are increasing at 7% annually, more than three times the general inflation rate, leading to a doubling of costs every decade, which is financially unsustainable for employers and individuals. * **Cost Stratification (80/20 Rule):** A disproportionate amount of healthcare spending is concentrated, with 20% of plan members generating 80% of costs, and the top 5% driving over 50% of total expenditures. Effective cost management requires addressing the care for these high-cost claimants. * **Major Diagnostic Drivers:** The primary diagnostic categories responsible for high healthcare costs are musculoskeletal (orthopedic and spine issues), cardiovascular emergencies (heart attacks, strokes), cancer (prolonged treatment), and complicated labor and delivery (especially for younger employee populations). * **Hospitals as Primary Cost Drivers:** Hospitals account for 50% of all healthcare costs, significantly more than professional fees or prescriptions. Their revenue generation strategies are a major factor in overall cost increases. * **Cross-Subsidization:** Hospitals systematically overcharge commercially insured patients and employers to compensate for the lower reimbursement rates received from Medicare, Medicaid, and self-pay patients, making employer-sponsored health insurance significantly more expensive. * **Hospital Consolidation Strategies:** Hospitals employ horizontal integration (mergers with other hospital systems) to reduce competition and gain pricing power, and vertical integration (acquiring physician practices) to create referral funnels, ensuring patient volume and increasing revenue. * **Perverse Incentives of Fee-for-Service:** The dominant "fee-for-service" payment model incentivizes hospitals to perform more services, regardless of necessity or quality, and disincentivizes value-based care models that aim for better outcomes at a fixed cost. * **Private Equity's Role in Doctor Fees:** Private equity firms acquire specific physician practices (e.g., ER, radiology, anesthesiology, pathology) and take them out-of-network to charge significantly higher rates (10-20x), leading to "surprise bills" for patients, though this practice is now regulated by law. * **Pharmaceutical Patent Exploitation:** Pharmaceutical companies exploit strong U.S. patent laws by creating "patent thickets" (dozens of patents on a single drug) and engaging in "pay-to-delay" schemes to extend market exclusivity and prevent generic competition, keeping drug prices artificially high. * **Indirect Pharma Incentives for Doctors:** Pharmaceutical companies influence prescribing patterns through indirect incentives to physicians, such as speaker fees, consulting fees for market insights, and providing free catered meals to physician offices. * **Extreme Medical Device Markups:** Medical devices, such as artificial knee and hip implants, experience massive markups. A device costing $300 to manufacture can be sold to a hospital for $3,000, which then bills commercial insurers $30,000, representing a 100-fold increase from the original manufacturing cost. * **Economic Principle of Revenue Generation:** The fundamental economic principle that "one person's spending is another person's income" is a core driver of healthcare costs, as various entities strategically increase their revenue, directly contributing to higher expenditures for others. **Key Concepts:** * **Rule of 70:** A method to estimate the doubling time of a value growing at a constant rate (70 divided by the annual growth rate). * **80/20 Rule (Pareto Principle):** In healthcare, 20% of patients drive 80% of costs, with further stratification showing 5% of patients driving 50% of costs. * **Cross-Subsidization:** The practice where hospitals charge commercially insured patients significantly more to cover the financial shortfall from lower payments by Medicare, Medicaid, and uninsured patients. * **Horizontal Integration:** The merger of companies at the same stage of production (e.g., hospital systems merging) to reduce competition and gain market power. * **Vertical Integration:** The acquisition of companies involved in different stages of the supply chain (e.g., hospitals buying physician practices) to control patient flow and referrals. * **Fee-for-Service:** A payment model where healthcare providers are reimbursed for each service they provide, incentivizing volume over value. * **Value-Based Payment/Capitation:** Alternative payment models that aim to incentivize quality and outcomes over volume, often involving fixed payments per patient or episode of care. * **Patent Thicket:** A strategy by pharmaceutical companies to file numerous overlapping patents on a single drug to extend its market exclusivity and deter generic competition. * **Pay-to-Delay:** Agreements where brand-name drug manufacturers pay generic drug manufacturers to delay the introduction of a generic version of a drug. **Examples/Case Studies:** * **Hospital Consolidation:** Banner Health in Phoenix and the Advocate Aurora/Ascension systems in Wisconsin are cited as examples of dominant hospital systems resulting from mergers, leading to higher healthcare costs due to reduced competition. * **Vertical Integration:** Atrium Health in Charlotte, North Carolina, is mentioned as a hospital system that attempted to mandate physician referrals to its own facilities, leading to doctors leaving to form independent practices. * **Pharmaceutical Patent Thickets:** Humira is highlighted as a leading example of a drug with dozens of patents, creating a "patent thicket" to extend its market exclusivity. * **Pay-to-Delay:** Takeda Pharmaceuticals is mentioned as a generic manufacturer that has been paid by brand-name companies to delay the production of generics. * **Medical Device Markups:** Artificial knee and hip implants are used to illustrate the 100x markup from manufacturing cost to the final bill for commercially insured patients.

19.7K views

38.7

1:11:56

Meet with Veeva!

Black Women In Clinical Research

/@BlackWomenInClinicalResearch

Nov 24, 2021

This video provides an in-depth exploration of Veeva Systems' vision for transforming clinical trials through digital innovation, focusing on speed, efficiency, and compliance. Bree Burks, a representative from Veeva, outlines the company's commitment to creating an end-to-end operating system for new product development in human health. The presentation, delivered to "Black Women In Clinical Research," details how Veeva is bridging content gaps and fostering global harmonization while supporting local autonomy in clinical research. Burks emphasizes Veeva's transition to a Public Benefit Corporation, signaling a long-term commitment beyond just profits, focusing on societal benefit, employees, customers, and human health. The core of Veeva's strategy revolves around "digital trials," which go beyond mere decentralization to encompass paperless, electronic, and truly synchronized processes. This approach aims to reduce trial costs and timelines by 25% by 2025, addressing the industry's current challenges of disconnected technologies, manual administrative tasks, and site burnout. Veeva's unified Vault platform serves as the foundation, integrating data, documents, and workflows across various applications, including quality, regulatory, clinical operations, safety, and commercial cloud. A significant portion of the discussion is dedicated to patient-centricity, exemplified by the MyVeeva for Patients application, which aims to provide a seamless, single-login experience for participants, contrasting with the current fragmented app landscape. A key differentiator highlighted is Veeva's "Site Connect" initiative, designed to automate the exchange of documents and information between sponsor/CRO systems (like Veeva TMF) and site systems (Veeva SiteVault). This direct, middleware-free connection addresses the massive administrative burden of document exchange, particularly for the 60% of TMF documents originating from sites. The e-consent process is presented as a concrete example of digital transformation, where consent templates are electronically sent, reviewed, approved by IRBs within the system, and then securely delivered to patients via MyVeeva, with automatic filing and version control. Furthermore, Veeva SiteVault is offered free to sites, providing a structured investigator site file and robust remote monitoring capabilities, allowing CRAs to access certified copies of source documents and engage in real-time document review and communication within the platform. Key Takeaways: * **Veeva's Public Benefit Corporation Status:** Veeva transitioned to a Public Benefit Corporation in 2023, legally committing to a vision beyond profits, focusing on society, employees, customers, and human health, signaling a long-term dedication to industry transformation. * **End-to-End Operating System Vision:** Veeva aims to provide a comprehensive operating system for the entire R&D process, from clinical operations to commercialization, connecting all stakeholders and applications to bring new products to market efficiently. * **Digital Trials vs. Decentralized Trials:** Veeva's "digital trials" vision emphasizes paperless, electronic, and synchronized processes across all trial types, not just decentralized ones, with a goal of reducing trial costs and timelines by 25% by 2025. * **Patient-Centric Technology (MyVeeva for Patients):** MyVeeva for Patients is an application designed for patients to provide a single, seamless, and synchronized experience for all trial-related interactions, contrasting with the current disconnected app landscape for participants. * **Transformative E-Consent Process:** Veeva's e-consent system enables electronic template exchange between sponsors/CROs and sites, in-system IRB approval, and direct, secure delivery to patients via MyVeeva, ensuring version control, automatic filing, and the ability to embed rich media and capture structured data. * **Site Connect for Automated Document Exchange:** Site Connect facilitates automated, direct document exchange between Veeva TMF (used by 60% of industry-sponsored studies) and Veeva SiteVault, eliminating manual email attachments and reconciliation for regulatory and source documents. * **Benefits of Connected Studies:** This connectivity reduces manual administrative burden, improves compliance by ensuring correct document versions are used and filed, enhances sponsor-site relationships, and provides cross-coverage for site staff. * **Veeva Vault's Unified Architecture:** All Veeva applications are built on a unified Vault platform, integrating data, documents, and workflows, ensuring seamless information exchange and improved functionality as more applications are adopted. * **Free SiteVault for Sites:** Veeva SiteVault is provided free of charge to sites, offering a comprehensive electronic investigator site file (eISF), e-consent, patient status tracking, and digital delegation logs, with documents hosted for 25 years. * **Enhanced Remote Monitoring Capabilities:** SiteVault supports advanced remote monitoring by allowing CRAs to access certified copies of site source documents, annotate, stage reviews, and track monitoring activities within the same Vault environment. * **Challenges in Digital Adoption:** A significant hurdle remains the transition of paper documents into electronic systems, although Veeva is developing tools like the TMF bot (using AI for auto-classification) and streamlined upload processes to ease this burden. * **Industry Mindset Shift:** The speaker advocates for the industry to value "connection over customization" to achieve true optimization and standardization, as excessive customization can hinder seamless integration and automation. * **Future Developments:** Veeva is continuously building, with plans to expand MyVeeva for Patients beyond e-consent to include all patient-related documents and communications, and to integrate granular patient visit data from SiteVault with payment systems. * **Career Opportunities at Veeva:** Veeva actively recruits individuals with clinical operations experience, particularly those interested in consulting roles for technology implementation, with a strong commitment to diversity and inclusion. **Tools/Resources Mentioned:** * **Veeva Vault:** The foundational platform for all Veeva applications. * **Veeva SiteVault:** A free eISF and site operations system for clinical research sites. * **MyVeeva for Patients:** A patient-facing application for engaging with clinical trials. * **Veeva TMF (Trial Master File):** A flagship product for managing sponsor/CRO trial documents. * **Veeva CDMS (Clinical Data Management System):** An EDC-plus system for modern data management, including IRT/IWR capabilities. * **Veeva CTMS (Clinical Trial Management System):** For managing clinical trial milestones and operations. * **Veeva Study Startup:** An application for tracking and managing study startup processes. * **Veeva Payments:** A system for managing site payments, linked to CTMS. * **Site Connect:** A feature enabling automated document exchange between Veeva TMF and SiteVault. * **TMF Bot:** An AI-powered tool for scraping and auto-classifying documents in the TMF. * **clinicaltrials.viva:** An upcoming application described as a "LinkedIn for clinical trials." **Key Concepts:** * **Digital Trials:** A comprehensive approach to clinical trials that are paperless, electronic, and synchronized, aiming for process transformation rather than just decentralization. * **Patient-Centricity:** Designing clinical trial processes and technologies with the patient experience at the forefront, ensuring ease of participation and engagement. * **Connected Studies:** The concept of seamlessly linking sponsor/CRO systems with site systems to automate document and information exchange, reducing manual effort and improving data flow. * **Unified Vault Platform:** Veeva's proprietary architecture where all applications are built on a single, integrated platform, allowing for shared data, documents, and workflows. * **Public Benefit Corporation (PBC):** A legal structure for a for-profit corporation that is committed to operating in a way that benefits society, employees, customers, and shareholders. * **E-consent:** The electronic process of obtaining informed consent from trial participants, often incorporating interactive elements and digital signatures. * **Remote Monitoring:** The practice of monitoring clinical trial data and documents remotely, often leveraging electronic systems to access site files and conduct source data verification (SDV). * **Source Data Verification (SDV):** The process of ensuring that data recorded in the case report forms (CRFs) matches the original source documents at the clinical site. **Examples/Case Studies:** * **Pfizer Vaccine Study:** Mentioned as an example of patients experiencing a fragmented and disconnected technology experience with multiple apps for a single trial. * **Bayer:** Identified as the first early adopter of Veeva's Site Connect technology for automated document exchange. * **IRB Approvals:** Veeva worked closely with major IRBs like WCG and Advarra, as well as academic medical centers such as Hopkins, Vanderbilt, and Penn, to get their e-consent technology approved and gather feedback.

163 views

39.3

Clinical ResearchBlack WomenClinical Trials

12:00

Iatrogenesis: Harm from Healthcare - Mortality and Economic Impact

AHealthcareZ - Healthcare Finance Explained

@ahealthcarez

Nov 14, 2021

This video provides an in-depth exploration of iatrogenesis, defined as harm caused by healthcare itself. Dr. Eric Bricker begins by establishing the term's Greek roots ("physician" and "origin") and immediately highlights its severe impact, citing a controversial but widely referenced study by Dr. Marty Makary from Johns Hopkins. This study suggests that iatrogenesis is responsible for 250,000 deaths per year in the United States, positioning it as the third leading cause of death, surpassing many well-known diseases. The speaker emphasizes that this harm extends beyond mortality to significant patient suffering, including side effects from medications and complications from surgical procedures. The presentation delves into specific examples to illustrate the nature of iatrogenesis. One common example is antibiotic-associated diarrhea, where antibiotics, while treating an infection, inadvertently kill beneficial gut bacteria, leading to severe gastrointestinal distress, dehydration, and even repeated hospitalizations. Another surgical example is dysphagia (difficulty swallowing) following a Nissen fundoplication, a procedure for severe heartburn. Dr. Bricker explains how improper tension during the surgical wrap of the stomach around the esophagus can lead to long-term swallowing problems for a significant percentage of patients. These examples underscore the unintended but serious consequences that can arise directly from medical interventions. A crucial aspect discussed is "informed consent," the process by which physicians are ethically and legally obligated to discuss the condition, treatment nature, anticipated results, alternatives (including non-treatment), and the risks, complications, and benefits of a proposed medical intervention with a patient. However, Dr. Bricker critically examines the practical shortcomings of informed consent, noting that it is often delegated to junior staff, performed with doctor bias, or even manipulated to ensure patient compliance. This gap between the ideal and the reality of informed consent means patients may not fully grasp the potential iatrogenic risks. The video then transitions to the significant economic burden of iatrogenesis, detailing how hospital inpatient complications lead to substantial costs, much of which is passed on to third-party payers and ultimately to employers through commercial insurance premiums. The economic analysis is particularly detailed, tracing the cost from a 2007 study on hospital inpatient iatrogenesis. The study found that while hospitals bore a direct cost of $238 per patient, they passed on an additional $1,775 per patient to third-party payers, totaling $2,013 per patient. Adjusting for healthcare inflation to 2021, this cost rises to $3,180 per patient. Factoring in the 88% passed to payers and the 40% typically covered by commercial insurance, Dr. Bricker calculates that iatrogenesis costs employers approximately $40.5 billion annually. This translates to a hidden cost of $522 per employee per year, or $44.50 per employee per month (PEPM), which is often more than the administrative service organization (ASO) fee for managing an entire employee health plan. This hidden financial impact, combined with the human suffering and mortality, underscores iatrogenesis as a critical and often overlooked issue in healthcare. Key Takeaways: * **Definition and Scale of Iatrogenesis:** Iatrogenesis refers to harm, suffering, side effects, or even death caused by medical care itself. It is a significant public health issue, with one study estimating 250,000 deaths per year in the US, making it the third leading cause of death. * **Diverse Manifestations of Harm:** Iatrogenesis can manifest in various ways, from medication side effects like antibiotic-associated diarrhea (affecting 5-35% of antibiotic users) to surgical complications such as dysphagia after a Nissen fundoplication (occurring in 3-24% of patients). * **Informed Consent: Ideal vs. Reality:** The concept of informed consent requires physicians to comprehensively discuss a condition, treatment, anticipated results, alternatives, and risks/benefits. However, in practice, this process is often flawed due to delegation to junior staff, physician bias, or even manipulation, leading to patients not being truly "informed." * **Significant Economic Burden:** Iatrogenesis imposes a substantial financial cost on the healthcare system. A 2007 study, adjusted for inflation to 2021, estimated the total cost of hospital inpatient iatrogenesis at $3,180 per patient. * **Hidden Costs for Employers:** A large portion of iatrogenesis costs (88%) is passed on to third-party payers, with commercial insurance bearing a significant share. This translates to an estimated $40.5 billion annually charged to commercial insurance plans, ultimately paid by employers. * **High Per-Employee Cost:** For employers, the cost of inpatient hospital iatrogenesis alone amounts to approximately $522 per employee per year, or $44.50 per employee per month (PEPM). This hidden cost often exceeds the administrative fees employers pay for their entire health plans. * **Lack of Transparency in Reporting:** These substantial iatrogenesis costs are typically hidden within general claims data and are not itemized in employer reporting, making it difficult for organizations to identify and address this specific financial drain. * **Impact on Pharmaceutical and Medical Device Industries:** The examples of harm from medications and surgical procedures directly relate to the products and services provided by the pharmaceutical and medical device sectors, highlighting the critical need for safety, efficacy, and robust post-market surveillance. * **Need for Improved Systems and Compliance:** The prevalence of iatrogenesis and the shortcomings of informed consent underscore the necessity for better systems, processes, and regulatory compliance to prevent medical errors and ensure patient safety. * **Relevance to Data Analysis and AI:** The hidden nature of iatrogenesis costs in claims data suggests a strong need for advanced data engineering and business intelligence to identify patterns, quantify impact, and inform strategies for mitigation. AI and LLM solutions could potentially assist in analyzing vast amounts of clinical data to predict risks, improve diagnostic accuracy, and enhance patient safety protocols. Key Concepts: * **Iatrogenesis:** Harm, suffering, side effects, or death caused by medical care itself. * **Informed Consent:** The process by which a patient gives permission for a medical procedure or treatment after understanding all the relevant facts, including risks and alternatives. * **Antibiotic-Associated Diarrhea (AAD):** Diarrhea caused by the disruption of beneficial gut bacteria due to antibiotic use. * **Nissen Fundoplication:** A surgical procedure to treat severe heartburn (GERD) by wrapping the upper part of the stomach around the lower esophagus. * **Dysphagia:** Difficulty swallowing, often a complication of surgical procedures affecting the esophagus. * **Per Employee Per Month (PEPM):** A common metric in employee benefits to express costs on a monthly basis per employee. Examples/Case Studies: * **Antibiotic-Associated Diarrhea:** Illustrated by a case of a 23-year-old woman hospitalized multiple times for severe diarrhea after taking antibiotics for a sinus infection. * **Nissen Fundoplication Complications:** Discussed in the context of food getting stuck in the esophagus (dysphagia) if the surgical wrap is too tight, affecting 3-24% of patients.

2.6K views

42.9

58:38

Superset Meetup: How Veeva Nitro is using Superset to power LifeSciences Analytics

Preset

/@Preset-io

Nov 11, 2021

This video provides an in-depth exploration of how Veeva Systems, a leading cloud software provider for the life sciences industry, leverages Apache Superset to power its Veeva Nitro analytics platform. Nitesh Baranwal, Director of Product for Veeva Nitro, and Chatham Reed, from Veeva's product management, detail Veeva's vision for an "industry cloud" for life sciences, covering both the development and commercial sides of the pharmaceutical coin. The presentation focuses on Nitro, their data science and analytics platform, which is specifically geared towards commercial operations. They explain how Nitro integrates proprietary Veeva data (CRM, CLM, Engage) with industry data (sales, claims, formulary) through robust data pipelines, making it available for analytics and data science. The speakers elaborate on the three key personas targeted by Veeva Nitro: system administrators who execute data pipelines, data analysts and scientists who build transformations and perform advanced analytics, and business users who consume reports and dashboards. A significant portion of the discussion centers on "Nitro Explorer," Veeva's bundled and packaged version of Apache Superset, which serves as their modern BI tool for HQ reporting, aiming to replace traditional tools like Tableau, Qlik, and Power BI. They highlight the strategic decision to adopt Superset, emphasizing its open-source nature, cloud-native compatibility, significant cost and time-to-market savings, and the strength of its community. Veeva has made several enhancements to the base Superset product to create Nitro Explorer, including direct connectivity to their data warehouse, S3-based workspaces for blending local files, integration with Nitro's existing authentication and authorization, and a unique multi-instance deployment model to support different customer groups or regions within a multi-tenant architecture. They also discuss challenges encountered, such as managing user expectations around SQL proficiency, handling large data volumes, and dashboard personalization. The presentation concludes with a showcase of various internal and external dashboards built using Nitro Explorer, demonstrating its versatility for use cases ranging from business benchmarking and digital event tracking to ETL job monitoring, sales performance, distribution analysis, medical insights, and digital engagement. Key Takeaways: * **Veeva's "Industry Cloud" Vision:** Veeva aims to provide an end-to-end cloud solution for the life sciences industry, supporting both the drug development (clinical operations, research) and commercialization (sales, marketing, safety) phases with software, data, and consulting services. * **Veeva Nitro's Role in Commercial Operations:** Nitro is positioned as an essential data science and analytics platform, integrating diverse data sources (Veeva products, industry data like sales and claims) through intelligent pipelines to power commercial analytics and strategic partnerships. * **Target Personas for Nitro:** The platform caters to system administrators for pipeline execution, data analysts/scientists for custom transformations and advanced modeling (forecasting, clustering), and business users for reporting and dashboarding, providing a comprehensive solution. * **Benefits of Veeva Nitro:** It offers accelerated time to value (weeks instead of months for data pipeline setup), delivers actionable insights through both field-facing (Veeva CRM MyInsights) and HQ-level reporting (Nitro Explorer), and is built as a flexible, cloud-native system on AWS leveraging a big data stack. * **Strategic Adoption of Apache Superset:** Veeva chose Superset (branded as Nitro Explorer) as its primary HQ BI tool due to its open-source nature, self-management capabilities, cloud-native integration, significant time-to-market advantage (saving months of development), and an active, supportive community. * **Commitment to Open Source:** Nitro Explorer represents Veeva's first user-facing open-source project, signifying a deep commitment to Superset, as it's not easily replaceable once integrated into customer workflows. Veeva plans to stay current with Superset versions and contribute back to the community. * **Multi-Tenant Deployment of Superset:** Veeva uniquely deploys Superset in a pseudo multi-tenant fashion using Kubernetes, allowing them to manage a single code line across all customers, which is crucial for their "product as a service" model in life sciences. * **Veeva's Enhancements to Superset (Nitro Explorer):** Key additions include direct connectivity to Veeva's data warehouse, S3-based "workspaces" for users to blend local files with enterprise data, integration with Nitro's SSO/authentication, and the ability to deploy multiple Explorer instances for regional or brand segregation. * **"Explorer for Explorer" for Usage Analytics:** Veeva developed a usage analytics dashboard within Nitro Explorer itself, by tapping into Superset's internal logs, to track top actions, most active users, and popular dashboards, which helps in developing future analytics roadmaps. * **Challenges and Best Practices:** Users coming from traditional BI tools require a mindset shift towards SQL proficiency for effective data set creation in Superset. Best practices for large datasets involve optimizing SQL at the data set level (filtering, projections, aggregations) to minimize data transferred to the dashboard. * **Internal Use Cases at Veeva:** Nitro Explorer is used internally by Veeva's Business Consulting team for benchmarking (migrating from Tableau) and by the Digital Events team (migrating from legacy .NET/SSRS) to rapidly create reports, and by service teams for ETL job monitoring. * **External Customer Use Cases:** Pharma customers utilize Nitro Explorer for diverse analytics, including sales performance, distribution center analysis (using arc maps), specialty sales tracking, medical insights (e.g., word clouds for trending topics), and digital engagement measurement. * **Rapid Dashboard Development:** The agility of Nitro Explorer allows teams to quickly build and deploy dashboards once data is onboarded, reducing reliance on traditional BI development cycles and empowering business users and analysts. **Tools/Resources Mentioned:** * **Veeva Products:** Veeva CRM, Veeva Nitro, Veeva CLM, Veeva Engage, MyInsights * **BI/Analytics Tools:** Apache Superset (Nitro Explorer), Tableau, Qlik, Power BI, MicroStrategy, Hotspot * **Cloud/Big Data Technologies:** Amazon Web Services (AWS), Amazon S3, Amazon EMR, Hadoop, Spark, Kafka, Kubernetes, Redshift (used as an IDP) * **Legacy Technologies:** .NET, SSAS (SQL Server Analysis Services), SSRS (SQL Server Reporting Services) * **Charting Libraries:** Echarts (mentioned as underlying Superset charts) **Key Concepts:** * **Industry Cloud:** A specialized cloud platform tailored for a specific industry, offering integrated software, data, and services. * **Public Benefit Corporation (PBC):** A type of for-profit corporate entity that includes positive impact on society, workers, the community, and the environment in addition to profit as its legally defined goals. * **Multi-tenant Architecture:** A single instance of a software application serves multiple customers (tenants), where each tenant's data is isolated and remains invisible to other tenants. * **Time Machine:** A concept within Veeva Nitro for aggregating and rolling up metrics by different cycles (e.g., quarterly, monthly) based on client needs. * **Field Reporting:** Analytics and reports designed for sales representatives and field-based teams, often accessed on mobile devices. * **HQ Reporting:** Analytics and dashboards for headquarters staff, typically used for strategic analysis and decision-making. * **Data Pipelines:** Automated workflows for moving and transforming data from various sources to a target destination for analysis. * **ETL (Extract, Transform, Load):** A data integration process that extracts data from sources, transforms it to fit business needs, and loads it into a data warehouse or other system. * **SSO (Single Sign-On):** An authentication scheme that allows a user to log in with a single ID and password to gain access to multiple connected systems without being prompted for credentials again. * **AuthN/AuthZ (Authentication/Authorization):** Authentication verifies user identity; Authorization determines what an authenticated user is allowed to do. * **Data API:** An interface that allows programmatic access to data, enabling other applications or services to retrieve or manipulate it. **Examples/Case Studies:** * **Pfizer and Moderna:** Mentioned as customers that Veeva helped through their vaccine development during the pandemic, highlighting the essential nature of the life sciences industry. * **Business Consulting Team Hackathon:** A 2-day workshop where Veeva's business consultants were able to convert 30-40% of their existing Tableau dashboards to Nitro Explorer, demonstrating the tool's rapid development capabilities. They are now near 100% conversion. * **Digital Events Team Migration:** An internal Veeva team migrating their reporting from a legacy .NET application using SSRS to Nitro Explorer, significantly reducing the time needed to create new reports. * **ETL Job Monitoring Dashboards:** Internal operational dashboards built by Veeva's service teams using Nitro Explorer to track daily/weekly job metrics, durations, and errors across client instances and connectors. * **Sales Performance Dashboards:** Examples of traditional sales performance dashboards, distribution analysis (using arc maps to show product spread), and specialty sales tracking, all replicated and enhanced in Nitro Explorer. * **Medical Insights Dashboard:** An example featuring a word cloud to visualize trending medical topics, top medical insights, and inquiries, helping reps prepare for doctor meetings. * **Digital Engagement Tracking:** A dashboard showing the correlation between increased digital engagement (e.g., virtual doctor contacts) and sales activity, particularly relevant during the pandemic.

957 views

33.2

1:02:57

Navigating eQMS in Medtech today with Greenlight Guru

Cannon Quality Group, LLC

/@cannonqualitygroup

Nov 9, 2021

This video provides an in-depth exploration of navigating Electronic Quality Management Systems (eQMS) in the Medtech industry, featuring a detailed demonstration of Greenlight Guru's platform. The session, hosted by Cannon Quality Group, aims to educate Medtech startups and established companies on the advantages and latest features of eQMS, which is increasingly becoming standard technology. The discussion highlights how eQMS can automate processes, improve compliance, reduce costs, increase productivity, enhance traceability, and alleviate documentation burdens, moving away from traditional lengthy and complex QMS implementations. Wade Schroeder, a Medical Device Quality Consultant from Greenlight Guru, positions their solution as a "Medical Device Success Platform" rather than just an eQMS, emphasizing its industry-specific design. Greenlight Guru is presented as the only eQMS built exclusively for medical devices, offering an out-of-the-box solution that handles validation for every release, thereby reducing a significant burden for users. The platform integrates core QMS functionalities, including document management with 21 CFR Part 11 compliant electronic signatures and robust change control, comprehensive training management with auto-tracked records, and structured quality processes for CAPA, customer feedback, non-conformances, and audits. A key differentiator highlighted is Greenlight Guru's multi-level design controls and risk management, which are built to align with ISO 13485, FDA 21 CFR Part 820, and ISO 14971. The platform enables users to build a full design control traceability matrix, linking user needs to design inputs, outputs, verifications, and validations directly within the system. This approach eliminates the need for separate requirement specifications and automatically generates the Design History File (DHF). The risk matrix is seamlessly integrated, allowing for a risk-based approach to design by linking design controls to specific harms and assessing initial and residual risk levels. The system also features an "Intelligent Document Management" system with built-in AI and a "Visualize" tool, which provides a dynamic, interconnected view of the entire quality system, helping users understand the impact of changes proactively. Key Takeaways: * **eQMS as a Medtech Standard:** Electronic Quality Management Systems are becoming essential for Medtech startups, offering significant benefits such as automation, improved compliance, cost reduction, increased productivity, enhanced traceability, and reduced documentation burden. * **Industry-Specific Solution:** Greenlight Guru is presented as a unique eQMS specifically designed for the medical device industry, ensuring alignment with sector-specific regulations and best practices, unlike generic QMS platforms. * **Pre-Validated and Continuously Updated:** The platform is an out-of-the-box solution that Greenlight Guru pre-validates with every release, removing the validation burden from customers and allowing for continuous product improvements without requiring re-validation. * **21 CFR Part 11 Compliance:** The system supports electronic signatures and maintains a detailed audit trail for all actions, ensuring compliance with 21 CFR Part 11 requirements for electronic records. * **Integrated QMS Ecosystem:** Greenlight Guru provides a fully integrated QMS where all elements—documents, projects, training, and quality processes (CAPA, complaints, non-conformances, audits)—are interconnected and traceable, serving as a single source of truth. * **Automated Design History File (DHF):** The platform automatically compiles the DHF by linking user needs, design inputs, design outputs, verifications, and validations, significantly streamlining the documentation process for regulatory submissions. * **Risk-Based Design Approach:** The system integrates risk management aligned with ISO 14971, allowing users to identify hazards, assess initial risk, link design controls as mitigations, and evaluate residual risk, providing a comprehensive risk file. * **Visual Project Management:** Design control matrices include visual indicators (e.g., green/pink for pass/fail, checkmarks for approved items) to help teams track progress and status of verifications, validations, and design reviews. * **Component-Based Design Controls:** Complex projects can be broken down into manageable subsections (e.g., software, electrical, mechanical components), allowing for focused reviews and easier navigation while maintaining overall traceability. * **Proactive Change Management with AI:** The "Visualize" tool leverages AI and natural language processing to show the interconnectedness of all QMS elements, enabling users to proactively assess the impact of changes across documents, projects, and quality processes. * **Automated Recommendations for Change Orders:** When initiating a change order, the system uses its AI capabilities to suggest other documents or items that might be impacted by the change, ensuring comprehensive consideration and reducing oversight. * **Comprehensive Quality Analytics:** Dashboards and analytics provide high-level reporting on change orders, CAPAs, audits, and customer feedback, offering insights into organizational quality health and supporting management reviews. * **Scalable Solution:** The platform offers different pricing and packaging tiers, allowing companies to start with essential functionalities (documents, change, projects) and add more advanced features as they grow and their needs evolve. * **Context-Aware Communication:** The system includes a comment feature that is context-aware, allowing users to add notes specific to a document or quality process and @mention colleagues for direct notifications and collaboration. **Tools/Resources Mentioned:** * **Greenlight Guru:** The eQMS and "Medical Device Success Platform" demonstrated. * **G2 Crowd:** A third-party review site mentioned for checking recommendations for Greenlight Guru. * **Greenlight Guru Academy:** An educational platform offering certifications and learning resources for the medical device industry. * **Greenlight Guru Blog/Podcast:** Content resources provided by Greenlight Guru for industry insights. **Key Concepts:** * **eQMS (Electronic Quality Management System):** A software system designed to manage and automate quality processes and documentation in a regulated industry. * **DHF (Design History File):** A compilation of records that describes the design history of a finished medical device. * **Design Controls:** A set of interrelated practices and procedures that are incorporated into the design and development process of a medical device. * **Risk Management (ISO 14971):** A systematic application of management policies, procedures, and practices to the tasks of analyzing, evaluating, controlling, and monitoring risk. * **CAPA (Corrective and Preventive Action):** A system for identifying and addressing existing nonconformities (corrective action) and preventing potential nonconformities (preventive action). * **21 CFR Part 11:** Regulations issued by the FDA that set forth requirements for electronic records and electronic signatures. * **ISO 13485:** An international standard for quality management systems specific to the medical device industry. * **FDA 21 CFR Part 820:** The Quality System Regulation (QSR) for medical devices in the United States. * **Visualize:** Greenlight Guru's AI-powered tool that graphically displays the interconnectedness of all QMS elements within the system. * **Natural Language Processing (NLP):** A form of AI that enables computers to understand, interpret, and manipulate human language, used in Greenlight Guru to auto-link documents based on content. **Examples/Case Studies:** The video uses a hypothetical "circuit board" as a central example to demonstrate various functionalities, including: * Linking the circuit board document to design outputs like an LCD screen or mechanical enclosure. * Showing how a complaint about the circuit board would be linked in the customer feedback and CAPA modules. * Illustrating how changes to the circuit board would trigger a change order and how the "Visualize" tool would show all impacted documents and design controls. * Discussing how different components (electrical, mechanical, software) can be managed within a single project's design control matrix.

746 views

31.2

eQmsQuality Management System

13:51

RegTalks about Regulatory Information Management Systems (RIMS)

Asphalion

/@Asphalion.

Nov 5, 2021

This video explores the critical role of Regulatory Information Management Systems (RIMS) within the pharmaceutical industry, particularly in light of the upcoming transition from XEVMPD to the more complex ISO IDMP standard. Featuring insights from Veeva's Director of Strategy for Vault RIM, Katrin Spaepen, the discussion highlights the drivers for RIMS adoption, essential capabilities of future systems, and the multi-departmental nature of their use. The speakers emphasize that RIMS are key to managing vast amounts of regulatory data, ensuring compliance, and optimizing operations for medicinal products. Key Takeaways: * **Strategic Importance of RIMS:** RIMS are fundamental for data management, operational efficiency, and maintaining regulatory compliance in the pharmaceutical industry, especially with the impending, more complex ISO IDMP standard. * **Drivers for RIMS Adoption:** Companies adopt RIMS for three primary reasons: driving enterprise-wide digital transformation, achieving process efficiencies and cost optimizations in regulatory domains, or ensuring compliance (often driven by mandates like IDMP). These drivers influence the scope and approach to implementation. * **Core Capabilities of Future RIMS:** Effective RIMS must offer native support for both data and documents, ensure synchronization between them, feature an open architecture for data exchange with non-RIM systems, provide a complete view of license data across the enterprise, and embed real-time reporting and business intelligence dashboards. * **Multi-Departmental Utility:** RIMS are not solely for regulatory affairs; they serve as an enterprise-wide solution involving various departments such as regulatory operations, CMC writers, medical writers, manufacturing, quality control, and safety, particularly in processes like post-approval variation management. * **Crucial Role of Implementation Partners:** Successful RIMS implementation necessitates strong partnerships for process re-engineering, organizational impact assessment, change management, gap analysis, and defining key performance indicators (KPIs) and user requirements (URS). * **Veeva's Market Presence:** Veeva's Vault RIM suite (encompassing submissions, archive, publishing, and registration) is positioned as a leading end-to-end solution supporting the full regulatory process, indicating its significance in the industry.

1.3K views

44.0

23:18

VISEVEN | Webinar | 2021| How to make the most of your Veeva content

Viseven

/@VisevenMarTech

Nov 2, 2021

This video provides an in-depth exploration of optimizing content management within the Veeva ecosystem for pharmaceutical and life sciences companies. The presenters, Maria and Nina from Viseven, begin by outlining common challenges faced by pharma marketers, such as the use of multiple content management systems, fragmented content storage, slow content lifecycles, high production costs, lack of content visibility, and the prevalence of irrelevant or outdated materials. They emphasize that in today's environment, success hinges on proper data management and the timely delivery of fresh, consistent information to healthcare professionals (HCPs). The core problem identified is the inefficiency and risk associated with managing digital assets across disparate systems, hindering effective customer-centric engagement. The webinar then introduces Viseven's eWizard platform as a comprehensive solution designed to address these issues. eWizard is presented as a content production platform driven by cost-effectiveness, a modular approach for efficient content reuse, and alignment with pharma's digital content production principles across multiple channels. Key capabilities highlighted include a modular content framework that enables the creation, update, and reuse of cross-channel modules, facilitated by eWizard's multi-channel content builder, localizer, and converter. This allows for easy assembly of channel-specific content (emails, e-detailers, websites) within global templates, effortless localization, and automatic publishing to various corporate ecosystems like Salesforce Marketing Cloud and Adobe Experience Manager, in addition to Veeva products. A significant portion of the presentation details the deep integration of eWizard with a suite of Veeva products, including Veeva CRM, Veeva Vault PromoMats, Veeva Approved Email, Veeva CLM, Veeva MyInsights, and Veeva Engage. These integrations are positioned as unlocking "unlimited opportunities" for content management, accelerating time to market, and enhancing compliance. Specific benefits include direct access to global content from Veeva Vault PromoMats, enabling users to add approved digital assets to presentations and control expiration dates. The integration also streamlines the approval process, allowing content to be approved within eWizard or automatically published to Veeva Vault for review with a single click. Furthermore, it automates the setup of required fields (country, therapeutic area, product) when uploading to Veeva Vault and facilitates multi-channel distribution to CRM systems, mobile apps, or web browsers. The video also covers how eWizard enables fast localization (up to four times faster) using global master templates and pre-designed components, adapting content for local cultural differences and ensuring compliance with CLM/CRM requirements for face-to-face and remote communication. The latter part of the webinar focuses on optimizing remote communication with HCPs and leveraging data for insights. eWizard, in combination with Veeva, provides tools to quickly adapt existing materials for online interactions, allowing users to customize presentation structures, rearrange slides, modify content, and create dynamic call flows. It also supports planning and conducting remote calls directly from eWizard or Veeva, sending personalized invitations, presenting interactive visual aids in real-time, and sending follow-up emails with surveys. Crucially, all data collected during remote calls is automatically synchronized and stored in Veeva, providing valuable customer insights for understanding needs, defining market share, and predicting sales potential. The integration with Veeva MyInsights is showcased for advanced monitoring, enabling users to create custom dashboards, visualize KPIs (basic monitoring like slide usage and advanced insights like doctor loyalty or prescription potential), and gain a 360-degree view of field activities to achieve commercial excellence. The presentation concludes by reiterating Viseven's status as a certified Veeva partner and the combined power of eWizard and Veeva for efficient, compliant, and accelerated content delivery. Key Takeaways: * **Challenges of Fragmented Content Management:** Many pharmaceutical companies struggle with multiple content management systems, leading to fragmented content, slow content lifecycles, high production costs, lack of visibility, and outdated materials, which ultimately hinders effective engagement with HCPs. * **Unified Content Management Solution:** An ideal content management system should provide a single solution for creating a holistic, customer-centric experience, coordinating all digital assets in one place to maintain effective customer relationships and ensure content is fresh and consistent. * **Modular Content Framework for Efficiency:** Viseven's eWizard platform utilizes a modular content framework, enabling the creation, update, and reuse of cross-channel modules. This approach significantly simplifies content production, remixing, and reuse for non-IT specialists, making it faster and more cost-effective. * **Deep Integration with Veeva Ecosystem:** eWizard offers extensive integrations with key Veeva products, including Veeva CRM, Veeva Vault PromoMats, Veeva Approved Email, Veeva CLM, Veeva MyInsights, and Veeva Engage, to streamline content flow and maximize the value of existing Veeva investments. * **Accelerated Content Approval and Distribution:** The eWizard-Veeva integration facilitates quick publishing for medical, legal, and regulatory (MLR) approval, reducing manual operations and developer involvement. It automates field population for Veeva Vault uploads and enables instant distribution across multiple channels like CRM systems, mobile apps, and web browsers. * **Global-to-Local Content Adaptation:** The platform supports a "global to local content hub," allowing brand managers and agencies to access approved global assets (templates, images, PDFs) and localize them effortlessly, ensuring consistency with global branding while adapting to local market needs and cultural differences. * **Optimizing Remote HCP Engagement:** The solution provides tools to quickly adapt existing materials for remote calls, allowing for customization of presentation structures, dynamic call flows, and distribution to field forces. This is crucial for maintaining HCP access and engagement, especially when face-to-face interactions are limited. * **Automated Data Synchronization for Insights:** Data collected during remote calls, email interactions, and other field activities is automatically synchronized and stored in Veeva. This enables companies to gain deep customer insights, understand HCP needs, define market share, and predict sales potential. * **Advanced KPI Monitoring with Veeva MyInsights:** The integration with Veeva MyInsights allows for dynamic KPI monitoring on two levels: basic (e.g., slides used, time spent) and advanced (e.g., doctor loyalty, prescription potential, competitor comparison). Users can create custom dashboards and visualize reports for improved decision-making. * **Cost and Time Savings:** By enabling in-house content editing and localization, the solution reduces reliance on external agencies, significantly cutting down on waiting times and additional budget expenditures for content updates and adaptations. * **Ensuring Regulatory Compliance and Brand Consistency:** The system helps maintain consistency and compliance with global branding and messaging, while also streamlining the approval process for medical and legal teams, ensuring all distributed content adheres to regulatory standards. * **360-Degree View of Field Activities:** The integrated system provides a comprehensive 360-degree view of all field activities, including completed and planned calls, orders, emails, and reaching frequency, allowing for better tracking of sales, marketing activities, and overall commercial excellence. * **Enhanced Email Marketing Flexibility:** Users can leverage pre-approved email templates from Veeva Vault, personalize them for target contacts, and send them directly from CLM presentations before, during, or after calls. The system also tracks email performance (opens, click-through rates) in real-time within the CRM. * **Viseven as a Certified Veeva Partner:** Viseven's status as a certified Veeva partner (Level 4 in multi-channel content creation and certified Veeva CRM administrator) underscores their expertise and the reliability of their integrations within the Veeva ecosystem. **Tools/Resources Mentioned:** * Viseven eWizard Platform * Veeva CRM * Veeva Vault PromoMats * Veeva Approved Email * Veeva CLM (Closed Loop Marketing) * Veeva MyInsights * Veeva Engage * Veeva CRM iPad * Salesforce Marketing Cloud * Adobe Experience Manager **Key Concepts:** * **Modular Content:** A content strategy where content is broken down into small, reusable components (modules) that can be easily assembled, updated, and localized across various channels and presentations, enhancing efficiency and consistency. * **Global-to-Local Content Hub:** A centralized repository and workflow that facilitates the adaptation and localization of global content assets (e.g., master templates, images, PDFs) for specific local markets, ensuring brand consistency while meeting local regulatory and cultural requirements. * **MLR Approval (Medical, Legal, Regulatory Approval):** The critical process in the pharmaceutical industry where all promotional and medical content must be reviewed and approved by medical, legal, and regulatory teams to ensure accuracy, compliance with regulations (e.g., FDA, EMA), and adherence to company policies before dissemination. * **Multi-channel Content Strategy:** An approach to content delivery that involves distributing content across various communication channels (e.g., e-detailers, emails, websites, mobile apps, remote calls) to reach target audiences effectively, ensuring a consistent message and optimized experience across all touchpoints. * **Dynamic KPIs (Key Performance Indicators):** Performance metrics that are automatically tracked, aggregated, and visualized on dashboards, often in real-time, to provide actionable insights into content effectiveness, sales performance, customer engagement, and other business objectives.

198 views

43.4

visevenewizardpharma marketing

4:11

CTMS & eTMF implementation – Flex Databases & FGK CRO case study

Flex Databases

/@Flexdatabases

Nov 1, 2021

This video presents a case study on the successful implementation of Flex Databases' Clinical Trial Management System (CTMS) and electronic Trial Master File (eTMF) for FGK CRO, a full-service contract research organization. The discussion highlights FGK CRO's objectives to standardize and simplify clinical trial management across various phases and sponsors, aiming for increased cost-effectiveness and quality. The video details the project scope, a rapid implementation timeline (5.5 weeks vs. 8 weeks estimated), and emphasizes the critical role of client involvement in achieving a smooth and accelerated deployment. Key decision factors for FGK CRO included the system's clear structure, intuitive handling, flexible modules (e.g., investigator payments), offline capabilities for CRAs, and the competence of the Flex Databases team. Key Takeaways: * **Active Market for eClinical Solutions:** CROs and pharmaceutical companies are actively investing in and implementing eClinical platforms like CTMS and eTMF to enhance the efficiency, standardization, and quality of clinical trial operations. * **Importance of Implementation Expertise:** Successful and expedited software implementation is a critical value proposition, with client-vendor collaboration and high client involvement being crucial for achieving faster-than-expected deployment times. * **Client-Centric System Selection:** Key criteria for selecting eClinical systems include intuitive user interfaces, clear structure, specific functional advantages (e.g., offline access for CRAs, flexible payment modules), and the vendor's team competence. * **Foundation for Advanced Data Solutions:** The successful deployment of core eClinical systems like CTMS and eTMF creates a structured data environment, which serves as an ideal foundation for integrating advanced data engineering, business intelligence, and AI/LLM solutions to further optimize clinical operations and regulatory compliance. * **Focus on Regulated Environments:** The context of clinical trials and eClinical systems inherently involves strict regulatory compliance

477 views

44.9

8:26

Electronic Medical Records Cost Employers $50 Per Employee Per Month

AHealthcareZ - Healthcare Finance Explained

@ahealthcarez

Oct 31, 2021

This video provides an in-depth exploration of the hidden financial burden imposed by Electronic Medical Records (EMRs) or Electronic Health Records (EHRs) on employers, estimating this cost at $50 Per Employee Per Month (PEPM). Dr. Eric Bricker, the speaker, explains that this significant expense is not transparently visible to employers but is instead deeply embedded within health insurance claims. A core issue highlighted is that many EMR companies charge a substantial percentage of physician practice revenue, with an example given of 7%. This business model inherently incentivizes EMR vendors to promote a fee-for-service approach, which maximizes billing and revenue, rather than encouraging value-based care or capitation models that focus on outcomes and cost efficiency. Dr. Bricker meticulously quantifies this administrative cost, demonstrating how a 7% EMR charge on the claims portion of an average employee's $10,000 annual health plan expense translates to approximately $595 per year per employee, or roughly $50 PEPM. Even after accounting for prescription drug spending, this cost remains around $40 PEPM. From a physician's perspective, the financial impact is equally stark: an EMR charging 7% of revenue means a primary care physician (averaging $1.4 million in annual revenue) or a specialist (averaging $1.6 million) could be paying an astounding $105,000 per year to their EMR vendor. This calculation suggests that a doctor might dedicate nearly one month of their annual work solely to cover EMR expenses, illustrating the profound administrative and financial exploitation within the existing healthcare system. The speaker then introduces an alternative model, Direct Primary Care (DPC), as a "better way" to mitigate these costs and inefficiencies. Using Atlas MD in Wichita, Kansas, as a prime example, Dr. Bricker explains how DPC practices operate by allowing physicians to opt out of traditional insurance billing. Instead, patients or their employers pay a direct, recurring subscription fee, typically $50 per month. This model significantly reduces administrative overhead, enabling DPC physicians to earn substantially more (e.g., 35% higher take-home pay, reaching $308,000 annually compared to $228,000 for fee-for-service doctors). Furthermore, DPC physicians can see fewer patients (e.g., 8 per day versus 25) and dedicate more time to each visit (e.g., an hour instead of seven minutes), leading to improved patient care and satisfaction. Dr. Bricker concludes by underscoring that administrative waste in healthcare is not merely a financial drain but also a detriment to patient access and quality of care. He posits that the substantial funds currently diverted to EMRs and other administrative processes could instead be utilized by physicians to provide free care to those in need, thereby fulfilling a crucial professional responsibility. The video serves as a compelling critique of the misaligned incentives and pervasive inefficiencies that characterize the current healthcare finance system, particularly those exacerbated by the revenue-sharing models of EMR vendors. Key Takeaways: * **Hidden EMR Costs for Employers:** Electronic Medical Records (EMRs) impose a substantial, often unrecognized, financial burden on employers, estimated at $40-50 Per Employee Per Month (PEPM). This cost is not a direct bill but is embedded within health insurance claims, making it largely invisible to employers. * **EMR Vendor Business Model:** Many EMR companies operate on a percentage-of-revenue model, charging physician practices a significant portion (e.g., 7%) of their collected revenue. This incentivizes EMR vendors to encourage maximum fee-for-service billing, thereby discouraging value-based care or capitation models. * **Staggering Physician Costs:** For individual physicians, EMR costs can be exorbitant, potentially reaching $105,000 per doctor per year based on average revenue figures. This implies that a physician might spend nearly one month of their annual work solely to cover their EMR expenses. * **Administrative Waste and Exploitation:** The current healthcare system is plagued by significant administrative waste, where a large portion of physician-generated revenue (e.g., $1.25 million out of $1.5 million) is siphoned off by various administrative layers, including EMR vendors and billing services, before reaching the physician. * **Impact on Physician Income:** While a primary care physician might generate $1.5 million in revenue, their take-home pay in a fee-for-service model could be as low as $228,000, illustrating the vast disparity caused by administrative overhead. * **Direct Primary Care (DPC) as an Alternative:** DPC offers a viable alternative by allowing physicians to opt out of insurance billing and directly charge patients or employers a subscription fee. This model significantly reduces administrative overhead and aligns incentives. * **Benefits of DPC for Physicians:** DPC physicians can achieve higher take-home pay (e.g., 35% more, reaching $308,000 annually) while seeing fewer patients (e.g., 8 per day vs. 25) and providing longer, more comprehensive visits (e.g., an hour vs. seven minutes). * **Reduced Overall Healthcare Costs in DPC:** The DPC model can drastically lower the overall cost to the healthcare system for patient care. A DPC practice might bill $480,000 for the same patient panel that would generate $1.5 million in a traditional fee-for-service setup. * **Patient Access and Professional Responsibility:** The pervasive administrative waste not only inflates costs but also negatively impacts patient access to care. Eliminating these inefficiencies could free up physician time and resources to provide pro bono care, addressing a historical professional responsibility. * **Misaligned Incentives:** The percentage-of-revenue model for EMRs exemplifies misaligned incentives in healthcare, where the financial success of administrative vendors is tied to maximizing billing rather than optimizing patient outcomes or cost efficiency. * **The "Creaming Off" Effect:** A substantial portion of the money spent by employers on healthcare claims is "creamed off" by various intermediaries and administrative services, including EMRs, before it directly benefits patient care or physician compensation. Key Concepts: * **EMR/EHR (Electronic Medical Record/Electronic Health Record):** Digital versions of a patient's paper chart, used by healthcare providers for clinical documentation, billing, and other administrative tasks. * **PEPM (Per Employee Per Month):** A common metric in employee benefits and healthcare finance to express costs on a monthly, per-employee basis. * **Fee-for-Service:** A payment model where services are unbundled and paid for separately. In healthcare, it gives an incentive for physicians to provide more services because payment is dependent on the quantity of care, not quality. * **Value-Based Care:** A healthcare delivery model where providers are paid based on patient health outcomes, rather than the volume of services provided. * **Capitation:** A payment arrangement where a healthcare provider is paid a fixed amount per patient per unit of time, regardless of how many services the patient uses. * **Direct Primary Care (DPC):** A healthcare model where patients pay a monthly or annual fee directly to their primary care provider for a defined set of services, bypassing insurance companies for routine care. * **MLR (Medical Loss Ratio):** The percentage of insurance premiums that an insurance company spends on claims and expenses that improve health care quality. The remaining percentage is for administrative costs, marketing, and profit. Examples/Case Studies: * **Atlas MD (Wichita, Kansas):** This practice is highlighted as an original Direct Primary Care model. It demonstrates how physicians can achieve 35% higher take-home pay ($308,000/year) compared to fee-for-service PCPs ($228,000/year) by charging patients a $50/month subscription fee and focusing on patient-centered care with fewer daily patient encounters.

2.3K views

40.0

31:28

Webinar: Webinars in Pharma. Are you ready to integrate Veeva and Salesforce Marketing journeys?

showerthinking

/@showerthinking

Oct 27, 2021

This video explores the strategic integration of webinar platforms with Veeva and Salesforce Marketing Cloud to create comprehensive, automated marketing journeys within the pharmaceutical and healthcare industries. The speakers advocate for a shift from viewing webinars as isolated tactics to leveraging them as integral touchpoints within a broader cross-channel customer experience, aimed at enriching HCP knowledge, generating leads, and optimizing digital marketing strategies. The discussion covers best practices for platform selection, data synchronization, consent management, HCP identification, and empowering sales representatives with real-time visibility and actionable insights. A detailed case study highlights a multinational pharma company's successful implementation, showcasing one-click registration, LinkedIn ad integration, and robust analytics using Google Tag Manager and DataRama to measure engagement via Key Educational Messages (KEMs). Key Takeaways: * **Strategic Shift for Webinars in Pharma:** Webinars should evolve from isolated events to integrated components of a larger, automated marketing journey, focusing on improving the HCP customer experience and enriching customer data. * **Seamless Cross-Channel Integration is Crucial:** Effective digital marketing in pharma requires a seamless integration between webinar platforms, Salesforce Marketing Cloud, and Veeva CRM, enabling journeys that can be triggered by reps (Veeva Approved Email) and digital channels (Marketing Cloud emails, social media, advertising). * **Data Synchronization and HCP Identification:** A core challenge and opportunity is to accurately identify HCPs across platforms, synchronize data (especially Veeva identifiers), and manage multi-channel consents within Veeva to personalize interactions and avoid redundant data requests (e.g., one-click registration). * **Empowering Sales Reps with Visibility and Actionable Insights:** Integrated solutions should provide reps with real-time visibility into HCP engagement on their Veeva timeline and suggest "next best actions" based on journey interactions, enhancing rep-HCP interactions. * **Comprehensive Analytics for Campaign Performance:** Beyond basic platform analytics, a robust solution integrates data from Veeva, Salesforce Marketing Cloud, webinar platforms, and advertising channels (like LinkedIn) into a business intelligence tool (e.g., DataRama) to measure campaign performance, track engagement (e.g., KEMs), and inform future strategies. * **Regulatory Compliance and Content Access:** Solutions must ensure that content access is restricted to verified HCPs, often through approval processes based on Veeva identifiers, and that all consent management adheres to industry regulations. * **Optimizing User Experience and Conversion:** Leveraging features like one-click registration, deep linking for content access, and native social media forms (e.g., LinkedIn forms) significantly improves the user experience and conversion rates for HCPs.

1.0K views

45.7

salesforcepharmasalesforce marketing cloud

11:42

Virtual Primary Care Article by Dr. Marshall Chin in New England Journal of Medicine

AHealthcareZ - Healthcare Finance Explained

@ahealthcarez

Oct 24, 2021

This video provides an in-depth exploration of virtual primary care (VPC), drawing insights from a New England Journal of Medicine article by Dr. Marshall Chin, an expert in chronic care. Dr. Eric Bricker, the presenter, begins by establishing the critical context that the COVID-19 pandemic starkly exposed the profound inadequacies and exclusionary nature of traditional, in-person-only primary care, particularly for chronic disease management. He highlights how this model disproportionately disadvantages vulnerable populations, including low-income individuals, hourly wage earners without paid time off, and those residing in rural or underserved areas, due to significant barriers such as transportation costs, childcare needs, and the sheer time commitment required for appointments. The core argument, championed by Dr. Chin and echoed by Dr. Bricker, is that telemedicine, specifically in the form of virtual primary care, offers a vastly superior alternative when combined with a per-member-per-month (PMPM) reimbursement model, as opposed to the traditional fee-for-service approach. This hybrid model, incorporating both virtual and necessary in-person care, promises increased access to high-quality medical expertise, enhanced convenience for patients who can manage appointments without significant disruption to work or family life, faster and timelier care delivery, and substantial cost-effectiveness by reducing the need for extensive physical infrastructure associated with conventional clinics and hospitals. However, the video pivots to a critical analysis of the major insurance carriers' recent initiatives to launch their own virtual primary care offerings. Dr. Bricker contends that despite the inherent benefits of VPC, these insurance-led models are fundamentally flawed and destined to fail due to five significant conflicts of interest and systemic issues. These include a pervasive lack of trust in insurance companies among both patients and doctors, the inherent conflict arising from insurance carriers owning Pharmacy Benefit Managers (PBMs) whose growth is tied to "script count" (potentially incentivizing over-prescription), the ethical dilemma of a doctor employed by an insurer having to fight their employer for prior authorizations, contractual restrictions preventing insurance carriers from "steering" patients to the highest quality providers within their networks, and the negative impact on employer flexibility when employees' primary care physicians are directly tied to a specific insurance plan. Key Takeaways: * **Inadequacies of Traditional Chronic Care:** The COVID-19 pandemic illuminated how the historical model of in-person-only primary care for chronic conditions (e.g., diabetes, hypertension) is inherently exclusionary, creating significant barriers for low-income individuals, hourly workers, and those in rural areas due to transportation, time off, and location challenges. * **Benefits of Virtual Primary Care (VPC):** VPC, especially when coupled with a per-member-per-month (PMPM) payment structure, offers superior primary care by providing increased access to quality doctors, enhanced convenience for patients, faster appointment scheduling, and greater cost-effectiveness through reduced infrastructure needs. * **Critical Role of Payment Model:** The video emphasizes that combining virtual care with a PMPM reimbursement model (rather than fee-for-service) is crucial for its success, aligning incentives towards proactive, holistic patient management rather than volume of services. * **Low Trust in Insurance Carriers:** A significant impediment to the success of insurance-led VPC is the pervasive lack of trust: only 33% of patients and a mere 19% of doctors trust health insurance companies, which will severely limit patient engagement and adherence to medical advice. * **PBM Conflict of Interest:** Insurance carriers' ownership of Pharmacy Benefit Managers (PBMs) creates a direct conflict, as PBM growth is often tied to "script count." This incentivizes insurance-employed doctors to potentially over-prescribe medications to maximize PBM revenue, undermining patient best interests. * **Prior Authorization Dilemma:** The process of prior authorization presents an ethical and practical conflict for primary care physicians employed by insurance companies, as they would be forced to advocate for their patients' diagnostic tests (e.g., MRIs, CT scans) against the financial interests of their own employer. * **Network Steerage Restrictions:** Many PPO contracts between major hospital systems and insurance carriers contain clauses that prohibit the insurance carrier from "steering" patients to specific providers within their network. This prevents insurance-employed PCPs from referring patients to the highest quality specialists, compromising patient care. * **Impact on Employer Flexibility:** Tying primary care doctors directly to an insurance carrier reduces employer flexibility. If an employer wishes to change insurance providers, it would necessitate forcing all employees to switch their primary care doctors, creating significant disruption and resistance. * **Shift Towards Virtual Care:** The broader healthcare industry is undeniably moving towards virtual care models, but the success hinges on addressing systemic issues and conflicts of interest rather than simply adopting the technology. * **Understanding Financial Incentives:** The focus on "script count" in PBM earnings calls highlights a key financial incentive within the pharmaceutical supply chain that can influence prescribing patterns and patient care. * **Relevance of Corporate Practice of Medicine:** The conflicts discussed, particularly around prior authorization and PBM incentives, underscore the importance and relevance of corporate practice of medicine laws designed to prevent undue influence on medical decisions. Key Concepts: * **Virtual Primary Care (VPC):** A healthcare delivery model that leverages telemedicine to provide primary care services, often combining virtual consultations with necessary in-person visits. * **Per Member Per Month (PMPM) Payment:** A capitated payment model where healthcare providers receive a fixed amount per patient per month, regardless of how many services are utilized, incentivizing preventive care and cost efficiency. * **Fee-for-Service:** A traditional payment model where providers are paid for each service they provide, potentially incentivizing a higher volume of services. * **Pharmacy Benefit Manager (PBM):** A third-party administrator of prescription drug programs for health insurance companies, often responsible for negotiating drug prices, processing claims, and managing formularies. * **Prior Authorization:** A requirement from health insurance companies that a healthcare provider obtain approval before prescribing a specific medication, performing a procedure, or ordering certain tests. * **Network Steerage:** The practice of an insurance carrier directing patients to specific providers or facilities within their network, often based on cost or quality metrics. * **PPO Contract:** A contract between an insurance carrier and a Preferred Provider Organization (PPO) network, outlining terms for patient access to providers and reimbursement rates. * **Corporate Practice of Medicine:** Laws that prohibit corporations from practicing medicine or employing physicians, designed to prevent non-physician entities from interfering with medical judgment. Tools/Resources Mentioned: * **New England Journal of Medicine (NEJM):** A prestigious medical journal, where Dr. Marshall Chin's article on virtual primary care was published (October 23, 2021 issue). * **UnitedHealth Group, Aetna, Anthem:** Major health insurance carriers cited as examples of companies announcing virtual primary care offerings. * **Sutter Health:** Mentioned as an example of a hospital system that faced issues related to network steerage in California.

2.6K views

41.0

9:46

Quality and Quality Systems (QMS and TQM) | Operations Management | Quality Control

Data Driven Management

/@datadrivenmanagement6230

Oct 20, 2021

This video provides a foundational understanding of quality and quality management systems, specifically discussing Total Quality Management (TQM) and Quality Management Systems (QMS). It begins by defining quality through various perspectives, such as fitness for use, conformance to specifications, and customer satisfaction, and then elaborates on key dimensions of quality including performance, reliability, durability, and serviceability. The discussion further breaks down quality into three aspects: quality of design, quality of conformance (manufacturing), and quality of performance (in use), highlighting their interconnectedness. The video then differentiates and relates TQM and QMS, presenting TQM as a company-wide philosophy focused on continuous improvement and customer satisfaction, while QMS is described as a system of standards, like ISO 9000, designed to help organizations meet customer and regulatory requirements. It outlines the principles of QMS, such as customer focus, leadership, and a process approach, and details the elements and outcomes of TQM, including waste elimination, defect reduction, and innovation. Key Takeaways: * **Foundational Quality Definitions:** Quality is multifaceted, defined by fitness for use, conformance to specifications, and customer requirements, with dimensions spanning performance, reliability, and serviceability, which are critical considerations for any product or service in regulated industries. * **QMS for Regulatory Adherence:** Quality Management Systems (QMS), particularly those based on ISO standards (e.g., ISO 9000, ISO 15189), provide structured frameworks for organizations to consistently meet both customer expectations and stringent regulatory requirements, which is essential for compliance in pharmaceutical and life sciences. * **TQM for Continuous Operational Excellence:** Total Quality Management (TQM) promotes a holistic, company-wide commitment to continuous improvement, employee involvement, and customer focus, aligning with the goal of optimizing operations and fostering long-term efficiency within complex enterprise environments. * **Integrated Quality Lifecycle:** Quality encompasses the entire lifecycle from design (quality of design) through implementation and manufacturing (quality of conformance) to actual use (quality of performance), emphasizing the need for quality considerations at every stage of solution development and deployment. * **Tangible Benefits of Quality Systems:** Implementing effective QMS and TQM leads to significant outcomes such as waste elimination, reduction of defects and variations, and fostering innovation, all of which directly contribute to improved efficiency and compliance in highly regulated sectors.

424 views

43.7

QualityQuality SystemsQuality management system

1:00:12

Hiring, Fostering and Engaging Black Talent at Veeva

WayUp

/@WayUp

Oct 20, 2021

This video provides an in-depth exploration of Veeva's strategies for hiring, fostering, and engaging Black talent, framed within the context of its operations as a leading software provider for the life sciences industry. The webinar, hosted by WayUp, features a panel of Veeva employees: Eric Soriano (Chief Diversity Officer), Dana Felks (Practice Manager, MedTech Services), and Tyler Binion (Associate Consultant). The discussion begins with an overview of Veeva's business, vision, and values, before delving into the panelists' personal career journeys and experiences with diversity and inclusion at the company. The core of the discussion revolves around Veeva's commitment to creating an inclusive work environment, particularly for new graduates. The panelists share insights into the challenges faced by Black new graduates entering the workforce and how Veeva's culture and programs address these. Tyler Binion, a recent graduate, highlights the importance of development programs that don't require prior industry-specific knowledge, emphasizing Veeva's investment in employee growth. Dana Felks, a manager, underscores the value of diverse teams for comprehensive viewpoints in addressing complex customer needs within the life sciences sector. Eric Soriano details Veeva's formal and informal initiatives to promote diversity and inclusion, which gained significant momentum following the Black Lives Matter movement. These efforts include the establishment of employee-led diversity communities, a shift in talent attraction strategies to broaden the talent pool, and fostering open dialogues about race and gender in the workplace. The company's status as a Public Benefit Corporation is also highlighted, signifying a legal obligation to balance shareholder interests with those of customers, employees, and communities, including the creation of high-quality employment opportunities. The video concludes with practical advice for new graduates seeking to start and grow their careers, emphasizing the importance of company culture, continuous learning, and embracing challenges. Key Takeaways: * **Veeva's Industry Focus:** Veeva is a software company building innovative solutions for the life sciences industry, serving pharmaceutical companies, medical device manufacturers, and clinical trial organizations. This aligns directly with IntuitionLabs.ai's target market. * **Comprehensive Service Offering:** Veeva provides integrated software products, data insights, implementation services, and business consulting for commercial strategy and operations within life sciences, mirroring many of IntuitionLabs.ai's service areas. * **Commitment to Employee Development:** Veeva offers "Generation Veeva" programs for new graduates, including Engineering, Consultant, Business Consulting, and Analytics Development Programs, designed to integrate and develop talent from day one, often without requiring prior industry-specific experience. * **Inclusion as a Core Value:** Veeva actively fosters an inclusive culture, demonstrated by employee-led diversity communities, transparent conversations about race and gender, and a focus on amplifying diverse voices. * **Talent Attraction Strategy:** The company broadens its talent pool by looking beyond traditional recruitment areas and emphasizing development programs that value potential and willingness to learn over extensive prior experience or specific majors (e.g., CDP is open to all majors). * **Mentorship and Autonomy:** Veeva supports employee growth through mentorship, providing autonomy to take on new challenges, make decisions, and lead teams, even if it means "throwing them to the fire" with necessary support. * **Embracing Challenges for Growth:** Panelists consistently advise new graduates to seek out and embrace challenging opportunities, as these are crucial for personal and professional development, even if initially daunting. * **Importance of Company Culture:** Candidates are encouraged to research and understand a company's culture beyond buzzwords, seeking environments where they feel comfortable, supported, and can genuinely grow. * **Resilience and Learning from Failure:** The advice includes being resilient, understanding that failure is a learning opportunity, and not being afraid to try new things or apply for roles even if one feels underqualified. * **Employee Well-being Initiatives:** Veeva supports employee morale and well-being through social events (virtual and in-person), an annual "GV Connects" gathering for new grads, formal mental wellness programs, flexible PTO, and a fitness reimbursement program. * **Global D&I Expansion:** Veeva plans to expand its diversity and inclusion efforts globally, recognizing that D&I looks different in various regions and requires tailored approaches beyond a U.S.-centric lens. * **"Infinite Mindset" for D&I:** Diversity and inclusion are viewed as an ongoing journey without a finish line, requiring continuous iteration, listening, and adaptation rather than a one-time initiative. * **Impact of Employee-Driven Initiatives:** Veeva encourages employees to propose and lead new initiatives, such as the "Young Black Professional Series," demonstrating a culture where new ideas are valued and supported. **Key Concepts:** * **Public Benefit Corporation (PBC):** A legal designation for a for-profit corporation that is committed to operating in a responsible and sustainable manner, balancing the interests of shareholders with those of customers, employees, and communities. Veeva was the first public company to convert to a PBC. * **Generation Veeva:** Veeva's collective term for its new graduate development programs, including Engineering, Consultant, Business Consulting, and Analytics Development Programs. * **Diversity Communities:** Employee-led groups within Veeva that aim to grow a diverse workforce, raise awareness about social issues, and celebrate different cultures and backgrounds. * **Infinite Mindset:** A concept applied to diversity and inclusion efforts, suggesting that it's a continuous journey of growth and evolution rather than a finite project with a completion point.

109 views

29.6

6:11

70 Percent of Doctors are Employed by Hospitals, Private Equity Firms or Insurance Companies

AHealthcareZ - Healthcare Finance Explained

@ahealthcarez

Oct 17, 2021

This video provides an in-depth exploration of the significant shift in physician employment patterns within the United States healthcare system, highlighting that 70% of doctors are now employed by large organizations rather than operating independently. Dr. Eric Bricker, the speaker, frames this trend as "fee-for-service on steroids," emphasizing the financial incentives driving this consolidation and its profound impact on medical practice and patient care. The presentation begins by citing recent reports indicating that 50% of doctors are employed by hospital systems, and an additional 20% are employed by private equity firms or insurance companies. This leaves only 30% of physicians practicing independently, a stark contrast to 20 years ago (around the year 2000) when 57% of doctors were independent. Dr. Bricker then delves into the motivations behind this shift, explaining that hospitals primarily employ physicians, particularly primary care physicians (PCPs), to control patient referrals. By directing referrals to their own specialists and facilities, hospitals can maximize revenue from facility fees, tests, and procedures, which represent a much larger financial opportunity than professional fees alone. The analysis further examines the role of private equity firms, which are inherently for-profit organizations that often acquire physician practices using significant debt. Their priority is to generate billing revenue to service this debt and deliver profits to investors, frequently leading to strategies like taking physicians out of network to charge higher fees. While insurance companies (like Kaiser Permanente's Permanente physician group) also employ doctors, their motivations may differ, often focusing on cost control within their integrated systems. However, Bricker stresses that regardless of the employer, an external force is influencing physician decisions. A specific focus is placed on primary care, where 43% of internal medicine physicians and 57% of family practice physicians are employed. This is crucial because PCPs are the gatekeepers for specialist referrals, and the rate of these referrals has dramatically increased over time: from 4.8% of PCP visits resulting in a referral in 1999, to 9.3% in 2009, and a staggering 18% in 2018 – meaning almost one in five PCP visits now leads to a specialist referral. This trend, likely exacerbated by shorter patient visit times, perfectly aligns with the hospital systems' strategy to drive more services and facility fees. The video concludes by asserting that this consolidation is now the norm, fundamentally altering the independence of physician decision-making in patient care. Key Takeaways: * **Dominance of Employed Physicians:** A significant majority, 70%, of doctors are no longer independent practitioners. This includes 50% employed by hospital systems and 20% by private equity firms or insurance companies, marking a dramatic shift from 57% independence two decades ago to just 30% today. * **Hospital Motivation: Referral Control and Facility Fees:** Hospitals employ physicians primarily to control the referral pipeline to their own specialists, tests, and procedures. This strategy allows them to maximize "facility fees," which are a much larger revenue stream than the professional fees earned by doctors, effectively turning healthcare into "fee-for-service on steroids." * **Private Equity's Profit Imperative:** Private equity firms, as for-profit entities, acquire physician practices with the goal of maximizing billing revenue to cover debt and generate investor returns. This often leads to practices being taken out of network to charge higher fees, prioritizing financial gain over other considerations. * **Insurance Company Influence:** While insurance companies (e.g., Kaiser Permanente) may have different motivations, such as integrated care and cost control, their employment of physicians still represents an external influence on doctors' decisions, impacting their autonomy. * **High Employment in Primary Care:** Primary care physicians (PCPs) show particularly high rates of employment, with 43% of internal medicine and 57% of family practice doctors working for larger organizations. This is strategically important for employers due to PCPs' role as referral sources. * **Dramatic Increase in Specialist Referrals:** The rate of primary care visits resulting in a specialist referral has quadrupled in less than two decades, from 4.8% in 1999 to 18% in 2018. This means nearly one in five PCP visits now leads to a referral, providing a constant stream of patients to specialists within employed systems. * **Impact on Physician Independence:** The overarching implication is that physician decisions regarding patient care are increasingly influenced by their employers' financial incentives and organizational structures, rather than being solely independent. This consolidation fundamentally alters the landscape of medical practice. * **"Fee-for-Service on Steroids" Concept:** This term encapsulates how the employment of physicians by large systems amplifies the fee-for-service model, driving greater utilization of services, tests, and procedures to maximize revenue for the employing entity. * **Implications for Pharma and Life Sciences:** This consolidation means that pharmaceutical and life sciences companies must adapt their commercial and engagement strategies. Understanding the influence of hospital systems and private equity on prescribing patterns and referral networks is critical for market access, sales operations, and medical affairs. * **Data-Driven Insights for Strategic Planning:** The trends and statistics presented (e.g., physician employment percentages, referral rate increases) are vital data points for companies developing business intelligence dashboards and AI solutions to track market shifts and optimize their commercial strategies. Key Concepts: * **Fee-for-Service:** A payment model where services are unbundled and paid for separately. This video highlights how physician employment by large organizations amplifies this model, driving higher utilization of services. * **Facility Fees:** Charges billed by hospitals or outpatient facilities for the use of their space, equipment, and support staff, distinct from the professional fees charged by physicians. These are a major revenue driver for hospitals. * **Private Equity in Healthcare:** Investment firms that acquire healthcare practices or facilities, often with the goal of increasing profitability through operational efficiencies, expansion, or strategic billing practices. * **Physician Independence:** The ability of doctors to make clinical and business decisions free from external organizational or financial pressures. The video argues this is significantly eroding. * **Referral Patterns:** The routes patients take from primary care physicians to specialists or specific facilities. These patterns are increasingly controlled by employing organizations. Examples/Case Studies: * **Kaiser Permanente/Permanente Physician Group:** Mentioned as the largest physician group in America, owned by the Kaiser Permanente insurance company, illustrating how insurance companies also employ doctors, albeit with potentially different motivations than hospitals or private equity.

5.3K views

36.7

38:45

RegTalks about Regulatory Information Management Systems (RIMS)

Asphalion

/@Asphalion.

Oct 15, 2021

This video provides an in-depth exploration of Regulatory Information Management Systems (RIMS), their evolving definition, key drivers for implementation, and their strategic importance beyond mere compliance within the pharmaceutical and life sciences industries. Featuring insights from Lidia Canovas of Asphalion and Esteve Clark of Ennov, a RIMS vendor, the discussion highlights how RIMS are becoming increasingly critical due to the approaching implementation of ISO IDMP and other structured content submission initiatives. The conversation establishes RIMS as a foundational element for managing the complexities of global regulatory affairs, emphasizing their role in consolidating information, tracking registrations, and influencing business strategy. The discussion traces the evolution of RIMS from simple tools designed to replace spreadsheets and bespoke databases to sophisticated platforms that emulate the entire regulatory business process. It positions RIMS as the third pillar alongside document management and publishing tools, forming a cohesive regulatory ecosystem essential for handling the unified submission of structured data and documents to health authorities. A significant portion of the talk focuses on the primary motivators for companies to adopt or refresh RIMS, including the mandate for structured content submissions like IDMP and UPD, the need to modernize outdated regulatory infrastructures, and the growing recognition of RIMS as a valuable source of intellectual property and business intelligence. Furthermore, the video delves into the practical benefits of RIMS, particularly in improving impact assessment. It illustrates how RIMS can provide internal regulatory intelligence, aid in strategic decision-making regarding product portfolios, and, most notably, offer a comprehensive view of the end-to-end costs and timelines associated with organizational changes, such as manufacturing improvements. A compelling case study reveals how one company leveraged RIMS data to determine that nearly 60% of manufacturing changes had a negative financial impact after considering all factors, including regulatory timelines. The speakers also broaden the scope of RIMS applicability, asserting their utility across human medicine, veterinary products, medical devices, and API manufacturing, and stress the importance of seamless integration with other enterprise systems like Quality Management Systems (QMS) for optimal efficiency and data consistency. Key Takeaways: * **Core Function of RIMS:** Regulatory Information Management Systems are designed to consolidate all regulatory information into a single source, enabling comprehensive tracking and management of global product registrations. This replaces fragmented data stored in spreadsheets or bespoke departmental databases. * **IDMP and Structured Content as Key Drivers:** The impending implementation of ISO IDMP (Identification of Medicinal Products) and other structured content submission initiatives like UPD (Union Product Database) are the most significant catalysts for companies to adopt or upgrade their RIMS, necessitating a unified approach to data and document submission. * **RIMS as a Regulatory Ecosystem Component:** RIMS are intrinsically linked with document management and publishing tools, forming a unified "regulatory ecosystem" where structured data and documents are managed in unison to ensure consistency and compliance with evolving regulations. * **Strategic Value Beyond Compliance:** While RIMS serve as essential compliance tools, their value extends significantly to operational efficiency, strategic planning, and providing critical business intelligence. They help influence future business and regulatory strategies by offering insights into past precedents and current statuses. * **Enhanced Impact Assessment Capabilities:** RIMS significantly improve impact assessment by providing a clear view of regulatory process mechanics, allowing companies to assess internal regulatory intelligence, evaluate product performance (e.g., sunset clauses), and contribute to activities like product transfers or mergers and acquisitions. * **Data-Driven Decision Making:** A powerful application of RIMS is the ability to integrate its data with other organizational data sources (e.g., manufacturing, quality) to perform comprehensive cost and timeline analyses for changes. One example cited a company using RIMS data to discover that 60% of manufacturing improvements had a negative financial impact when all end-to-end costs and approval timelines were considered. * **Importance of System Integration:** Direct integration between RIMS and other enterprise systems, particularly Quality Management Systems (QMS), is highly advantageous. This seamless communication streamlines information flow, reduces manual effort, and ensures consistency across critical organizational functions. * **Broad Applicability Across Sectors:** RIMS are not exclusive to human medicines but are equally crucial for veterinary products, consumer health, medical devices, and even API manufacturers. The complexity of global registrations necessitates these tools regardless of the product type. * **Company Size is No Longer a Barrier:** The need for a RIMS is driven by the inherent complexity of global registrations, not company size or revenue. Small, innovative companies preparing for their first registration can benefit as much as large multinationals, and the competitive RIMS marketplace offers solutions for all scales. * **Diverse Stakeholders and Data Consumption:** While regulatory departments typically own RIMS, the data collected within them is valuable to a wide array of internal stakeholders, including clinical management, artwork and labeling, pharmacovigilance, quality management, portfolio management, intellectual property, sales, and marketing. * **Criticality of Data Exchange Capabilities:** Modern RIMS must offer robust capabilities for exposing and exchanging data with other systems, often through data marts. This ensures that valuable regulatory information is accessible and consumable by various groups across the organization, provided the context of the data is understood. * **Role of Implementation Partners:** Engaging world-class implementation partners is crucial for a successful RIMS deployment. These partners bring specialized expertise, save time and money, help navigate the RIMS landscape, and ensure the chosen solution aligns with specific company needs and integrates smoothly with existing systems. * **Proactive Adaptation to Evolving Regulations:** Adapting to new standards like ISO IDMP requires early involvement, a clear understanding of overall objectives, and proactive development. Strategic partnerships with software providers and implementation vendors are essential to ensure the RIMS continuously evolves with regulatory changes. **Examples/Case Studies:** * **Manufacturing Change Assessment:** A high-tech company utilized its existing RIMS data to analyze the economic and practical sense of manufacturing changes. This analysis revealed that almost 60% of manufacturing improvements, despite being beneficial to the manufacturing process, had a negative financial impact overall due to end-to-end costs (including regulatory affairs) and lengthy approval timelines. This led to a significant shift in how manufacturing changes were evaluated.

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14:59

Veeva Summit Keynote: Veeva Development Cloud Vision

Veeva Systems Inc

/@VeevaSystems

Oct 14, 2021

This video keynote from Veeva Summit outlines Veeva's strategic vision for building an integrated "industry cloud" for life sciences, the Veeva Development Cloud, which spans the full product lifecycle from clinical to regulatory, quality, and safety on the Vault platform. The speaker details significant platform enhancements, updates across their application suites, and introduces the ambitious Digital Trials Platform. The discussion also touches on Veeva's recent conversion to a Public Benefit Corporation, emphasizing a long-term commitment to balancing stakeholder interests. A key segment features an interview with Jörg Möller of LEO Pharma, highlighting their partnership with Veeva on digital trials and the anticipated benefits of shortening development timelines and reducing costs. Key Takeaways: * Veeva's overarching strategy is to create a unified industry cloud for life sciences, integrating clinical, regulatory, quality, and safety operations on the Vault platform to enhance efficiency and effectiveness across the product lifecycle. * Recent Vault platform enhancements include Microsoft Office integration with collaborative authoring and Excel report templates, the upcoming Vault Mobile app for secure document access, and the new Action UI for a more productive and modern user experience. * The Vault Quality suite is expanding with new offerings like Vault Validation Management for digital validation processes, Vault LIMS for optimizing quality control, and Veeva Learn GxP, a content library of accredited e-learning courses for GxP training. * Veeva's Clinical (CTMS, EDC, CDB) and Safety solutions are maturing rapidly, demonstrating strong adoption and enterprise-wide implementation by major pharmaceutical companies, reflecting the industry's need for integrated solutions in these complex areas. * A major multi-year initiative is the Veeva Digital Trials Platform, designed to fundamentally improve clinical trial information flow by connecting sponsors, patients, and research sites through applications like Site Connect, e-Consent, e-PRO, virtual visits, e-Source, and sensor data, aiming to enhance patient experience and streamline operations. * Partnerships with early adopter customers, such as LEO Pharma's collaboration on the digital trials platform, are crucial for product development and validation, with LEO Pharma targeting a 25% reduction in clinical development timelines and costs. * Veeva's conversion to a Public Benefit Corporation reinforces its commitment to a balanced, long-term approach that prioritizes customer and employee success alongside shareholder value, particularly as technology becomes increasingly vital to life sciences.

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