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Navigating the Impact of New EU Regulations EU CTR
Astrix On Demand Webinars for Life Sciences
/@astrixlifescience
Jun 22, 2023
This video provides a comprehensive overview of the new EU Clinical Trial Regulation (EU-CTR) and its accompanying Clinical Trials Information System (CTIS), detailing their transformative impact on the regulatory landscape for pharmaceutical and life sciences companies. The speaker outlines the intent to simplify the regulatory model, enhance patient safety, and increase transparency across the European Union, moving from a fractured country-by-country directive to a unified regulation. Key changes include a single authorization procedure, a centralized CTIS for all submissions and communications, and significantly increased public transparency of clinical trial data. The presentation also delves into critical operational impacts on electronic Trial Master Files (eTMF) and Regulatory Information Management (RIM) systems, highlighting challenges related to new document types, extended archiving requirements, tight response timelines for regulatory queries, and the need for robust internal process adjustments. Key Takeaways: * **Unified EU Regulatory Framework:** The EU-CTR, effective from January 2022 with full transition by January 2025, replaces the previous directive with a single, streamlined regulation and a centralized CTIS for all clinical trial applications and communications across EU/EEA member states. * **Enhanced Transparency and Public Access:** CTIS introduces public workspaces, making significant clinical trial data and documentation (e.g., protocols, results, inspection reports) publicly available after standardized timelines (1 to 7 years post-study, depending on phase), with exceptions for personal or commercially confidential data. * **Strict Timelines and Consequences:** Sponsors face stringent 12-day deadlines for responding to regulatory queries; failure to comply results in automatic application lapse. Authorizations also expire if no patients are recruited within two years, and serious breaches must be reported within seven days. * **Significant Operational and Systemic Impacts:** The regulations necessitate major adjustments to study startup processes, eTMF and RIM systems. This includes managing new document types, adhering to 25-year archiving requirements, clarifying the repository for rolling submissions (eTMF vs. RIM), and adapting to co-sponsorship and low-interventional study definitions. * **Critical Need for Internal Alignment and System Enhancements:** Organizations must conduct thorough impact analyses, clearly define roles and responsibilities across clinical operations, regulatory, and IT departments, and implement system enhancements to track compliance, manage new requirements, and support the CTIS. Updating SOPs, providing comprehensive training, and establishing robust change management are essential for successful adaptation. * **Opportunities for AI/Automation:** The complexities of managing redaction requirements for public transparency, the tight RFI response timelines, and the need for consistent compliance tracking across a unified system present clear opportunities for AI and automation solutions to streamline processes and reduce administrative burden.
What's Inside Typical Clinical Research Source Documents? An Inside Look!
Dan Sfera
/@dansfera
Jun 12, 2023
This video provides a foundational understanding of clinical research source documents, explaining their critical role beyond mere data collection. The speaker emphasizes that source documents are essential for demonstrating Good Clinical Practice (GCP), ensuring patient safety, documenting Principal Investigator (PI) oversight, and verifying protocol compliance, adhering to ALCOA principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete). It highlights the limitations of Electronic Data Capture (EDC) systems in capturing the nuanced narrative and process details necessary for regulatory compliance and audit trails, advocating for the continued importance of detailed source documentation, particularly progress notes. The video also touches upon the common elements found in source documents, such as informed consent, inclusion/exclusion criteria, adverse events, concomitant medications, and investigational product accountability, noting the variability and protocol-specific details for each. The discussion points to the industry's evolving landscape, where solutions like eSource (e.g., CRIO, and the mention of Veeva Site Vault in the description) are beginning to integrate and blur the lines between traditional source and EDC to address these challenges. Key Takeaways: * **Source Documents are Foundational for Compliance:** Source documentation is indispensable for demonstrating adherence to Good Clinical Practice (GCP), ensuring patient safety, and proving protocol compliance, going beyond just capturing raw data. * **EDC Limitations Highlight Need for Narrative:** Current EDC systems are often insufficient for capturing the detailed narrative, process of consent, PI oversight, and contextual information (e.g., for adverse events or medication changes) that progress notes in source documents provide, which is crucial for audits and query resolution. * **ALCOA Principles Drive Documentation Requirements:** The need for source documents is rooted in the ALCOA principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete), which dictate high standards for data integrity and traceability in clinical research. * **Proper Source Design Enhances Protocol Compliance:** Well-designed source document templates are vital for streamlining study visits, assisting researchers, and proactively ensuring consistent adherence to complex protocol requirements. * **Evolving Landscape of eSource and EDC Integration:** The industry is moving towards more integrated eSource solutions that aim to bridge the gap between traditional source documentation and EDC, indicating a growing demand for advanced digital tools to manage clinical data and compliance. * **Long-Term Value of Detailed Documentation:** Comprehensive and detailed source documentation, especially progress notes, is critical for addressing data queries that may arise long after a visit, ensuring continuity and accuracy for future reviews or audits.
Veeva Systems (VEEV) Q1 2023 Earnings Call Summary
SpeedyEarnings
/@SpeedyEarnings-le4ht
Jun 6, 2023
This video summarizes Veeva Systems' Q1 2023 earnings call, highlighting the company's strong financial performance and strategic advancements across its product portfolio. Key discussions revolved around the ongoing transition to Vault CRM, the integration of generative AI features like the CRM bot and Service Center, and the expansion of its data offerings with new Compass products and Link. The call also provided updates on Veeva's clinical data management solutions, quality management suite adoption, and insights into the stable yet cautious macroeconomic environment affecting project scrutiny in the life sciences sector. Key Takeaways: * **Veeva's Strategic Shift to Vault CRM with Integrated AI:** Veeva is actively transitioning customers from its legacy CRM to Vault CRM, a process anticipated to span from 2025 to 2029. A significant draw for this migration is the integration of new features like Service Center and a Generative AI-powered CRM bot, indicating a strong push towards AI-enhanced commercial operations. * **Deepening Investment in AI and LLM Solutions:** Veeva views AI as a critical component to enhance the value of its core systems of record. The development of proprietary data assets and applications, alongside an open ecosystem for customers to integrate their own AI, signals a future where AI and LLMs will play an increasingly central role in pharmaceutical commercial and clinical operations. * **Data as a Core Competitive Advantage:** Veeva is expanding its data product suite with Compass (prescriber and sales data) and Link (real-time customer intelligence), positioning them as modern, integrated alternatives to incumbents like IQVIA. This strategy emphasizes providing better, unified data for actionable insights. * **Modernization of Clinical Data Management:** The company is making significant strides in clinical data management with its EDC system, enabling faster study builds and seamless amendments. Plans for efficient, standardized integration with Drug Safety Systems aim to replace legacy providers and offer greater efficiency across the industry. * **Increased Scrutiny on Life Sciences Projects:** While the macro environment is stable, there's heightened caution from larger companies and tighter funding for emerging biotechs. This leads to increased scrutiny on project spending, favoring investments in core capabilities like CRM, safety, and regulatory compliance over discretionary or one-off projects. * **Growing Traction for Quality Management Solutions:** Sanofi's adoption of Veeva's unified Quality Management Suite underscores the market's demand for integrated solutions that streamline documentation, ensure higher quality standards, and modernize operations, aligning with regulatory compliance needs.ai to offer complementary solutions.
This CEO Thinks Noncompetes Hurt The Economy | Forbes
Forbes
/@Forbes
May 17, 2023
This video features an interview with Peter Gassner, founder and CEO of Veeva Systems, a leading cloud software, data, and professional services provider for over a thousand life sciences companies, including major pharmaceutical firms and small biotechs. Gassner discusses two significant aspects of Veeva's corporate philosophy and structure: its pioneering transition to a Public Benefit Corporation (PBC) and its strong stance against non-compete agreements. He explains that as a PBC, Veeva is legally bound to balance the interests of its employees, customers, and shareholders, a departure from the traditional shareholder-maximization model. This approach, he argues, fosters a more durable company, deeper customer trust, and the ability to attract values-aligned talent, ultimately benefiting long-term investors. Gassner also passionately advocates for the elimination of non-compete clauses, viewing them as detrimental to employee freedom and the broader U.S. economy, while distinguishing them from necessary intellectual property protections. He reflects on the evolution of his leadership mindset from short-term startup survival to long-term responsibility and societal impact. Key Takeaways: * **Veeva's Strategic Vision as a PBC:** Veeva Systems, a critical platform in the life sciences industry, operates as a Public Benefit Corporation, legally committing to balance the interests of all stakeholders (employees, customers, shareholders). This signals a long-term, trust-based approach to business, which is vital for partners and clients.ai, this indicates a stable and ethically aligned ecosystem with their primary platform provider. * **Impact of PBC on Customer Relationships:** The PBC model allows Veeva to cultivate longer and deeper relationships with its customers, who feel they have an actual seat at the table.ai in their Veeva CRM consulting to emphasize the long-term partnership and trust clients can expect. * **Non-Compete Stance Reflects Employee-Centric Values:** Veeva's ban on non-compete agreements highlights a commitment to employee freedom and a belief that such clauses hinder economic growth. * **Long-Term Durability and Trust:** Gassner emphasizes that the PBC structure contributes to Veeva's durability and efficiency by fostering trust with both customers and employees.ai building solutions on their platform, potentially enhancing client confidence. * **Evolving Leadership for Societal Impact:** The CEO's journey from a startup mindset to one focused on generational responsibility and societal impact underscores a mature and values-driven leadership.
What Systems Do You Need to Know as a Clinical Trial Manager?
ClinEssentials
/@ClinEssentials
May 15, 2023
This. This video explores the five essential systems Clinical Trial Managers (CTMs) need to master for effective oversight of clinical trials: the Interactive Voice Response System (IVRS), Clinical Trial Management System (CTMS), Electronic Data Capture (EDC) system, Lab Portal, and IRB Portal. The speaker, Tiffany Ashton, details how CTMs utilize each system to pull critical metrics, monitor study progress, ensure data quality, manage regulatory submissions, and support site operations. She emphasizes the importance of CTMs having direct access and proficiency in these systems to proactively manage trials, respond to sponsor inquiries, and maintain a pulse on overall study performance, from recruitment and data integrity to safety and regulatory compliance. Key Takeaways: * **Multi-System Proficiency for CTMs:** Clinical Trial Managers require hands-on familiarity with a suite of specialized systems (IVRS, CTMS, EDC, Lab Portal, IRB Portal) to effectively manage and monitor clinical trials. * **Data-Driven Oversight:** Each system provides unique, critical data points—from patient recruitment and randomization metrics (IVRS) to monitoring reports and protocol deviations (CTMS), real-time source data (EDC), lab results and alerts (Lab Portal), and regulatory submission statuses (IRB Portal). * **Operational Efficiency & Reporting:** CTMs leverage these systems to pull reports, track key performance indicators, respond to sponsor requests, and ensure timely communication, underscoring the need for efficient data access and reporting capabilities. * **Regulatory & Compliance Management:** The video highlights the CTM's direct responsibility for managing central IRB submissions and tracking protocol deviations, emphasizing the critical role of these systems in maintaining regulatory compliance.ai to offer AI-powered solutions, data engineering, and business intelligence services to integrate, automate, and provide actionable insights from these crucial clinical trial data sources.
The Changing Dynamic Between Clinical Operations and IT
Healthcare IT Today
/@HealthcareITToday
May 11, 2023
This video explores the profound evolution of IT's role within healthcare, transitioning from a basic infrastructure provider to an indispensable partner in clinical operations and patient care. The discussion highlights the critical need for close collaboration between traditionally siloed IT and clinical departments to drive digital transformation, improve clinician experiences, and ultimately enhance patient outcomes. A central theme is the immense pressure on healthcare IT, which faces increasing technological complexity and stagnant resources, necessitating innovative approaches and third-party support to "do more with less." The interview with Goliath Technologies' CEO emphasizes how end-user experience monitoring, powered by automation and intelligence, provides crucial data-driven insights to proactively manage application performance and bridge the communication gap between IT and clinical leadership. Key Takeaways: * **IT's Integral Role:** IT has become fundamental to every executive-level initiative in healthcare, directly impacting operational efficiency, clinician satisfaction, and patient care, especially with the widespread adoption of EHRs and Telehealth. * **Cross-Functional Imperative:** Successful digital transformation in healthcare demands strong leadership and seamless collaboration between IT and clinical teams, moving beyond purely technical projects to address human-centric goals like clinician satisfaction. * **Resource Scarcity & Complexity:** Healthcare IT departments operate with significantly fewer financial and human resources than their enterprise counterparts, yet must manage highly complex, multi-vendor technology environments, creating a constant challenge to optimize performance. * **Data-Driven End-User Experience:** Proactive monitoring and objective data analytics on end-user application experience are vital for identifying performance bottlenecks, making informed operational adjustments, and improving overall clinician workflow and satisfaction. * **Direct Link to Patient Outcomes & Burnout:** Poor IT performance and application latency directly contribute to clinician frustration and burnout, and can critically delay patient care, underscoring the direct correlation between IT efficiency and clinical effectiveness.
End to End Regulatory Information Management Case Study of a Veeva RIM Implementation
Astrix On Demand Webinars for Life Sciences
/@astrixlifescience
Apr 19, 2023
This. The discussion covers critical aspects like harmonizing global regulatory processes, managing data migration and integration from legacy systems, ensuring compliance, and navigating large-scale enterprise software adoption within the life sciences industry. This video explores an end-to-end Veeva Regulatory Information Management (RIM) system implementation for a top 10 pharmaceutical company, transitioning from disparate legacy systems to a globally consistent solution. The speakers discuss the complexities of harmonizing processes and terminology across global teams managing regulatory, CMC, and safety submissions. The case study highlights a multi-year journey involving current state assessment, future state design, detailed requirements gathering, configuration, and phased rollout strategies. A key theme is the collaborative approach between the client, Astrix (the consulting firm), and Veeva, emphasizing strong program management, communication, and meticulous planning for process and data readiness, as well as user adoption in a highly regulated environment. Key Takeaways: * **Complex Global Harmonization:** Large pharmaceutical companies face significant challenges in harmonizing regulatory processes and terminology across global teams due to reliance on disparate legacy tools (spreadsheets, SharePoint, bespoke systems). * **Structured Multi-Workstream Approach:** Successful large-scale implementations require a highly structured approach with dedicated workstreams for different functional areas (e.g., CMC, Safety, Regulatory, Authoring, Archive, Labeling), ensuring focused effort and expertise. * **Criticality of Process & Data Readiness:** Meticulous assessment of current processes, definition of harmonized future states, alignment on terminology, and comprehensive data mapping, migration, and integration planning are fundamental to a successful RIM system rollout. * **Vendor Collaboration is Key:** Direct and continuous collaboration with the software vendor (Veeva) is crucial for understanding system capabilities, best practices, configuration options, and leveraging product roadmaps for future enhancements. * **Comprehensive Change Management & Adoption:** Effective user adoption plans, including stakeholder analysis, continuous communication (newsletters, intranet), and tailored training, are essential to manage the learning curve and ensure business continuity during phased rollouts. * **Navigating Implementation Hurdles:** Common challenges include managing team member bandwidth, coordinating global time zones, addressing workstream dependencies, and adapting to system changes while maintaining ongoing critical operations and submission deadlines. * **Phased Rollout Strategy:** An iterative, phased rollout, starting with core capabilities and gradually expanding scope based on system readiness, legacy constraints, and business continuity, is an effective strategy for managing large-scale enterprise software implementations.
ISO 9001 - 2015 | QMS | Quality Management System | Global QMS | Summarized Video | DNG Academy
DNG Academy
/@dng-academy
Apr 8, 2023
This video provides a comprehensive overview of ISO 9001:2015, the international standard for Quality Management Systems (QMS). It delves into the definition of quality and QMS, outlining the standard's history, key revisions, and its 10 core clauses. The speaker highlights the numerous advantages of implementing ISO 9001, such as improved customer satisfaction, enhanced process efficiency, better risk management, and increased stakeholder confidence. Furthermore, the video offers practical guidance through 10 smart techniques for successful ISO 9001 implementation, alongside a discussion of common challenges organizations face during this process. Key Takeaways: * **Foundational QMS Framework:** ISO 9001:2015 provides a globally recognized, systematic approach to quality management, emphasizing continuous improvement, customer satisfaction, and the effective management of processes, which is critical for regulated industries. * **Strategic Focus Areas:** The standard places a strong emphasis on risk-based thinking, leadership commitment from top management, and understanding the organizational context, all of which are vital for robust quality and compliance strategies. * **Tangible Business Benefits:** Implementing ISO 9001 can lead to significant operational and reputational advantages, including streamlined processes, reduced waste, improved decision-making, enhanced supplier relationships, and a stronger market reputation. * **Structured Implementation Approach:** Successful adoption requires a structured approach involving top management buy-in, detailed project planning, gap analysis, comprehensive employee training, robust document control, and regular internal audits. * **Anticipating and Mitigating Challenges:** Organizations should be prepared for common implementation hurdles such as resistance to change, resource limitations, the complexity of the standard, and the need for effective communication and employee involvement to ensure sustained compliance and improvement.
Veeva Systems Stock | Cheap or Expensive ???
KNTV
/@kncashtv
Mar 27, 2023
This video explores a financial analysis of Veeva Systems (VEEV stock), discussing whether its current valuation makes it a cheap or expensive investment. The speaker delves into Veeva's business model, highlighting its dominant position within the pharmaceutical, biotech, and medtech industries, serving these sectors with cloud-based solutions across Development, Commercial, and Data Clouds. A significant portion of the discussion focuses on Veeva's impressive revenue growth, market capitalization, and the strategic importance of its flagship Vault platform, which accounts for 60% of its revenue. The analysis also touches upon customer stickiness due to deep product integration, Veeva's substantial total addressable market (TAM), consistent execution on long-term revenue goals, and the role of R&D in maintaining its competitive edge.ai offers its AI, CRM consulting, and data engineering services. * **High Customer Stickiness:** Veeva benefits from significant customer lock-in due to deep product integration and the complexity of switching systems, indicating a stable and entrenched market for related consulting and integration services. * **Strong Growth and Market Potential:** Veeva's consistent revenue growth, large total addressable market, and ambitious long-term targets confirm the robust and expanding demand for specialized cloud solutions in the life sciences sector.
Introduction to Deviation Handling and Root Cause Analysis
Scilife
/@ScilifePlatform
Feb 24, 2023
This video provides a comprehensive introduction to deviation handling and root cause analysis within the context of manufacturing medicinal products and medical devices. It emphasizes the critical role of a robust Quality Management System (QMS) that incorporates GxP and quality risk management to ensure product quality, patient safety, and adherence to regulatory expectations, including references to 21 CFR. The speaker details the systematic process for managing non-conformities and deviations, from identification and reporting through investigation, risk assessment, corrective and preventive actions (CAPA), effectiveness checks, and periodic reviews. The discussion highlights the importance of thorough investigation to determine root causes, classifying deviations based on criticality using risk assessment tools like FMEA, and addressing various types of errors including human, documentation, equipment, and process-related issues. The video also touches upon the benefits of electronic quality management systems (eQMS) for streamlining these processes and maintaining an agile, compliant environment. Key Takeaways: * **Structured Deviation Management:** An effective QMS requires a clearly defined, multi-phase process for handling deviations and non-conformities, encompassing identification, investigation, risk assessment, CAPA implementation, effectiveness verification, and periodic review to ensure continuous quality and compliance in life sciences. * **Risk-Based Classification:** Deviations should be classified (critical, major, minor, incident) using quality risk management principles and tools like Failure Modes and Effects Analysis (FMEA), which considers severity, probability of occurrence, and detectability, to prioritize investigation efforts and resource allocation. * **Thorough Root Cause Analysis (RCA):** Investigations must employ systematic RCA methodologies (e.g., 5 Whys, Fishbone diagrams, FMEA) by cross-functional teams to identify the true underlying causes of non-conformities, rather than just superficial symptoms, to prevent reoccurrence. * **Comprehensive Error Categorization:** Root causes often stem from human errors (emission or commission, intentional or unintentional), documentation deficiencies (e.g., obsolete SOPs, lack of training), equipment malfunctions, or process deviations from established parameters, all of which require specific attention during investigation. * **Importance of CAPA Effectiveness:** Corrective and Preventive Actions (CAPAs) must be identified, implemented, and rigorously monitored for their effectiveness in line with quality risk management principles, demonstrating to auditors and inspectors that the quality system is actively preventing issues and maintaining a validated state. * **Leveraging Electronic Systems:** Electronic Quality Management Systems (eQMS) are crucial for streamlining the deviation management process, integrating event data with other quality processes like change controls and calibrations, and facilitating agile, documented, and compliant operations, which aligns with the need for regulated enterprise software.
![The Good, the Bad, and the Ugliness of Regulation [No. 86 LECTURE]](https://i.ytimg.com/vi/FgTRVi23LGo/maxresdefault.jpg)
The Good, the Bad, and the Ugliness of Regulation [No. 86 LECTURE]
The Federalist Society
/@TheFederalistSociety
Feb 23, 2023
This video, "The Good, the Bad, and the Ugliness of Regulation," features Professor Susan Dudley discussing the origins, functions, and impact of administrative agencies and regulations in the U.S. It delves into the historical context of administrative law, tracing the evolution from early economic regulations to the modern prevalence of social regulations concerning environment, health, and safety. Professor Dudley explains the constitutional debates surrounding agency powers, the significance of the Administrative Procedure Act, and various methods for measuring the vast scope and economic impact of regulations. She highlights that while regulations are often perceived as burdensome, they are fundamentally justified by market failures such as externalities and asymmetric information, which are particularly relevant in complex industries like pharmaceuticals and life sciences. Key Takeaways: * **Foundational Role of Agencies:** Administrative agencies emerged to address the increasing complexity of society, operating under legislative delegation (e.g., Administrative Procedure Act of 1946) to create detailed regulations that Congress lacks the expertise or capacity to write. * **Shift to Social Regulation:** While early regulation focused on economic aspects, there has been a dramatic and continuing increase in "social regulation" since the 1970s, covering areas like environment, health, safety, and workplace conditions. This category directly encompasses the regulations critical to the pharmaceutical and life sciences industries. * **Market Failures as Justification:** The primary rationale for regulation stems from market failures, including externalities (costs borne by third parties, like pollution) and asymmetric information (where one party lacks crucial information, such as product safety or efficacy). * **Vast and Growing Regulatory Landscape:** There are at least 100 federal agencies issuing thousands of regulations annually, with 50-100 "economically significant" regulations (>$100 million impact) each year.ai helps its clients manage through AI and consulting services. * **Challenges in Measuring Regulatory Impact:** Unlike fiscal budgets, there's no single, comprehensive measure for the total impact of regulations, making it difficult for businesses to fully grasp and comply with the "stock" of existing rules (Code of Federal Regulations) and the "flow" of new ones (Federal Register). This complexity highlights the value of specialized consulting and AI solutions for compliance tracking.
CRC Turned Clinical Research Site Director Turned Consultant At Veeva Systems Talks Key Site Issues
Dan Sfera
/@dansfera
Jan 6, 2023
This video explores critical operational aspects of clinical research sites, featuring Savannah Erickson, a consultant at Veeva Systems, who shares her journey from a Clinical Research Coordinator (CRC) to a Site Director and her current role. The discussion highlights the complexities of managing high-volume studies, optimizing CRC workload, and navigating interactions with sponsors and CROs. A central theme is the industry's ongoing transition from paper-based systems to electronic regulatory platforms, with a specific focus on Veeva Site Vault. Savannah emphasizes the importance of sites maintaining robust internal processes and confidently pushing back against mandates that could lead to inefficiencies, while also touching upon the challenges of CRC burnout and talent retention within the industry. Key Takeaways: * **Digital Transformation in Site Operations:** The clinical research industry is undergoing an accelerated shift from paper to electronic regulatory systems (e.g., Veeva Site Vault), which is becoming essential for operational efficiency, compliance, and future business development opportunities for sites. * **Site Autonomy and Pushback:** Sites, especially those with established quality processes and deep protocol knowledge, should confidently push back against sponsor/CRO mandates (e.g., specific source document templates, deviation interpretations) that may create dual work or inefficiencies, advocating for their own proven, compliant methods. * **CRC Workload and Burnout:** Managing high CRC workloads requires strategic prioritization, starting with patient safety, followed by study-specific enrollment priorities. High pressure and workload contribute significantly to CRC burnout, influencing experienced professionals to seek roles in tech or sponsor organizations. * **Robust Internal Systems for Compliance:** Efficient site operations rely on strong internal quality assurance and regulatory departments, proactive monitor visit preparation, and daily operational meetings to ensure continuous inspection readiness and seamless management of multiple studies. * **Leveraging Academic Talent:** The clinical research sector offers valuable career paths for advanced degree holders (e.g., psychology masters) in specialized roles such as psychometric raters at CNS sites, providing an alternative to traditional academic careers and addressing specific industry needs.
Episode 6: Data Managers: Driving the Future of Clinical Research
Veeva Systems Inc
/@VeevaSystems
Dec 2, 2022
This video directly addresses the evolving landscape of clinical data management within the pharmaceutical industry, the strategic importance of data, and the increasing role of advanced technologies like AI/ML. This video explores the transformative journey of clinical data management, highlighting its shift from a back-office function to a strategic imperative driving the future of clinical research. Richard Young and Mayank Anand discuss how data professionals' roles are evolving in an era of decentralized data, emphasizing the critical need for data to optimize trial protocols, operations, and patient access to treatments. The conversation delves into GSK's innovative approach to data strategy and management, which integrates various data functions and prioritizes an enterprise mindset, stakeholder collaboration, and patient-centricity. A key theme is the operationalization of AI/ML in clinical research, moving beyond buzzwords to real-world applications, while also considering ethical implications and the need for continuous professional evolution. Key Takeaways: * **Strategic Elevation of Data Management:** Clinical data management is no longer a secondary function but is now "front and center" in optimizing clinical trials, requiring professionals to drive the future of research rather than just support it. * **AI/ML as an Operational Reality:** AI and Machine Learning are no longer just buzzwords but are becoming integral to clinical data management, offering significant opportunities for efficiency and transformation, necessitating discussions around ethical AI and regulatory alignment. * **Integrated Data Strategy for End-to-End Oversight:** Leading pharmaceutical companies like GSK are adopting a holistic "Data Strategy and Management" approach, consolidating functions such as data acquisition, medical coding, core data management, centralized monitoring, and data analytics to ensure comprehensive and strategic data oversight. * **Enterprise Mindset and Collaborative Innovation:** Successful data transformation requires an "enterprise mindset" that considers all stakeholders (clinical operations, biostats, pharmacovigilance, etc.) and fosters collective ownership, utilizing agile methodologies to accelerate delivery and manage complex interdependencies. * **"Total Experience" for Adoption and Impact:** Designing new technologies and processes with "Total Experience" (TX) in mind—encompassing change management, communication, and the impact on all end-users, including patients and investigators—is crucial for successful adoption and achieving desired outcomes. * **Evolving Role of Data Professionals:** The traditional "data manager" role is transforming into future-oriented positions like "data scientist" or "data engineer," emphasizing continuous learning and adaptation to new technologies, rather than fearing job displacement by AI. * **Challenges in Infrastructure and Data Democratization:** Significant industry challenges persist in modernizing legacy infrastructure and achieving broader data democratization, highlighting areas for future innovation and collaborative efforts to unlock the full potential of clinical data.
Deviations in Pharmaceutical industry l Interview Questions
PharmGrow
/@PharmGrow
Nov 15, 2022
This video provides a comprehensive overview of deviations within the pharmaceutical industry, framed as a series of interview questions and answers. It covers the fundamental definition, classification, and regulatory importance of deviations, alongside detailed discussions on their investigation, impact assessment, and management within a Quality Management System (QMS). The speaker emphasizes the structured approach required for handling deviations, from initial identification and reporting to root cause analysis, corrective and preventive actions (CAPA), and closure, highlighting the critical role deviations play in ensuring product quality and regulatory compliance. Key Takeaways: * **Foundational Role in QMS & Compliance:** Deviations are defined as departures from established procedures and are a core component of pharmaceutical QMS, directly impacting regulatory compliance (e.g., ICH Q10, GxP). Proper handling is a regulatory expectation. * **Structured Investigation & Impact Assessment:** The process involves classifying deviations (minor, major, critical), forming cross-functional teams (CFTs) for investigation, utilizing various tools (e.g., 5 Why, Fishbone, FMEA), and performing comprehensive impact assessments on existing, previous, and future batches. * **Timeliness and Root Cause Focus:** Prompt reporting (within 24 hours) and adherence to defined closure timelines are crucial for effective deviation management. The primary goal is to identify the root cause (or most probable cause) to prevent recurrence, with human error being a frequently cited factor. * **QMS Software Integration:** The video explicitly mentions specialized software like TrackWise as commonly used for deviation handling, indicating the industry's reliance on dedicated systems for managing these critical processes. This highlights an opportunity for AI-powered enhancements or custom integrations. * **Procedural Rigor and Data Integrity:** The discussion underscores the need for clear procedures for various scenarios, such as distinguishing deviations from incidents, avoiding "planned deviations" in favor of change controls, and the importance of not covering multiple discrepancies in a single deviation. The deviation count serves as an indicator of the overall health and control of a facility's QMS.
Important Elements From An Investigative Site File Regulatory Binder For A Clinical Research Monitor
Dan Sfera
/@dansfera
Nov 7, 2022
This video provides a detailed overview of the essential elements within an Investigator Site File (ISF), also known as a regulatory binder, from the perspective of a clinical research monitor. The speaker outlines critical documents and logs that monitors scrutinize during site visits to ensure regulatory compliance and proper study conduct within clinical trials. Key areas of focus include protocol adherence, staff training and delegation, informed consent management, investigational product (IP) accountability, protocol deviation tracking, and oversight by Institutional Review Boards (IRBs) and for Serious Adverse Events (SAEs). The discussion emphasizes the practical, pragmatic approach monitors take to ensure sites maintain comprehensive and up-to-date documentation, highlighting the continuous nature of compliance checks. Key Takeaways: * **Criticality of Investigator Site File (ISF) Management:** The ISF (regulatory binder) is central to clinical trial compliance, requiring meticulous management of documents such as protocols, delegation logs, staff training records, informed consents, and investigational product (IP) accountability logs. * **Monitor's Role in Ensuring Regulatory Adherence:** Clinical Research Monitors (CRAs) focus on verifying key elements like PI signatures on protocol amendments, current staff training and delegation, proper IP storage and dispensing (including temperature logs), and timely IRB continuing reviews to ensure ongoing compliance. * **Proactive and Continuous Monitoring:** The video emphasizes that critical aspects like IP accountability and informed consent amendments require continuous, proactive monitoring throughout the study lifecycle, rather than being deferred to closeout, to maintain data integrity and patient safety. * **Interconnectedness of Compliance Documentation:** Many regulatory documents are interdependent; for example, protocol deviations necessitate documented training, highlighting the complexity of maintaining a fully compliant and auditable ISF. * **Implications for AI and Data Solutions:** The detailed, log-intensive, and highly structured nature of ISF management and monitoring, as described, presents a clear opportunity for AI-powered solutions to enhance compliance tracking, automate audit trails, and streamline data integrity checks
Veeva Vault 22R2 Release Questions and Answers || Veeva 22R2 New Release Features || Veeva Vault Que
The Corporate Guys
/@TheCorporateGuys
Nov 5, 2022
This video provides an in-depth overview of the new features introduced in the Veeva Vault 22R2 release, primarily aimed at administrators and users preparing for the associated certification exam. The speaker, Vaibhav Agrawal, details three significant enhancements: improved configuration migration with "Outbound Package View and Add Dependencies," streamlined content discovery through "Add Documents to Expanded Search" (Search Collections), and advanced reporting capabilities by supporting "Document Roles as a Reporting Object." The discussion also covers the exam structure, passing criteria, and important considerations for each new feature. Key Takeaways: * **Enhanced Configuration Migration:** The "Outbound Package View and Add Dependencies" feature allows administrators to proactively identify and include missing dependent components (e.g., picklist values, document fields) when migrating configurations between Veeva Vault environments (e.g., sandbox to production). This significantly reduces deployment errors by ensuring all necessary components are moved together, with a maximum display of 2000 dependent components. * **Consolidated Content Search:** "Search Collections" enable users to group up to 15 objects and a single document type into a unified collection, facilitating a single-point search for related records and documents. This eliminates the need to navigate multiple tabs, improving efficiency in content discovery, provided the "Allow Expanded Search" option is enabled during collection creation. * **Advanced Document Role Reporting:** The introduction of "Document Role" and "Document with Document Role" as new report types empowers administrators to generate detailed reports on user roles and group assignments across documents. This allows for analysis of active/inactive users with specific document permissions (e.g., owners, reviewers), and when "Document" is the primary object, "Users and Groups" can also be selected as related reporting objects. * **Veeva 22R2 Exam Preparation:** The video outlines the critical aspects of the Veeva Vault 22R2 certification exam, including a deadline of December 16th, a passing score of 80% (8 out of 10 questions), and specific policies for retakes based on initial performance. * **Practical Implementation Details:** For each feature, the speaker provides practical details such as navigation paths (e.g., Admin > Settings > Search Collections), specific checkboxes to enable functionality, and limitations (e.g., only one document type per search collection, maximum three related objects for relationships).
2022 RDCA-DAP Workshop: Case Study 3, Duchenne Regulatory Science Consortia (D-RSC)
Critical Path Institute
/@CriticalPathInstitute
Oct 5, 2022
This video presents a case study from the Duchenne Regulatory Science Consortia (D-RSC) by the Critical Path Institute, focusing on efforts to accelerate therapeutic development for Duchenne Muscular Dystrophy (DMD). Speaker Terina Martinez highlights the significant challenges in DMD drug development, including high clinical trial failure rates, disease complexity, and difficulties in patient selection and endpoint measurement. To address these issues, D-RSC has developed a Clinical Trial Simulation (CTS) tool. This tool leverages a rich, integrated database of patient-level data from numerous clinical trials and natural history studies to train and validate quantitative disease progression models. The goal is to enable in silico evaluation and refinement of clinical trial designs, optimizing parameters like sample size and duration, and simulating drug effects. The tool is undergoing regulatory qualification with both the EMA and FDA, emphasizing its rigor and potential to improve trial efficiency, reduce participant burden, and stimulate further data sharing within the rare disease community. Key Takeaways: * **Data-Driven Clinical Trial Optimization:** The D-RSC's Clinical Trial Simulation (CTS) tool exemplifies how aggregating and analyzing extensive patient-level data from clinical trials and natural history studies can be leveraged to create quantitative disease progression models. This enables in silico evaluation and optimization of trial designs for rare diseases like DMDai. * **Regulatory Qualification of Novel Methodologies:** The active pursuit of regulatory qualification for the CTS tool through both EMA's Qualification of Novel Methodologies and FDA's Fit for Purpose Initiative highlights the growing importance of formally validating advanced computational tools for use in drug development and decision-making. This directly * **Impact on Trial Efficiency and Data Sharing:** Such simulation tools are crucial for improving clinical trial efficiency by optimizing sample size, trial duration, and patient selection, thereby reducing the burden on rare disease patient populations. Regulatory approval also acts as a strong catalyst for increased data sharing among stakeholders, underscoring the value of robust data integration and management. * **Addressing Rare Disease Challenges with Technology:** The initiative directly tackles the unique complexities of rare disease drug development, including high failure rates, heterogeneity in disease progression, and the need for better clinical endpoints, by providing a data-driven approach to de-risk and accelerate therapeutic advancement.
How to use the TMF Reference Model with Document Samples.
Power of Work
/@powerofwork6914
Oct 4, 2022
This video provides a comprehensive guide to navigating the TMF (Trial Master File) Reference Model, a standardized filing structure widely adopted in clinical trials, primarily based on the DIA reference model (version 3.2). The speaker systematically walks through the ten "zones" of the TMF, detailing the types of documents expected in each, such as trial management plans, central trial documents (e.g., protocols, investigator brochures, informed consent forms), regulatory submissions, IRB documents, site management records (e.g., 1572 forms, protocol signature pages), investigational product (IP) documentation, safety reports, central lab certifications (CLIA, CAPA), third-party vendor agreements, and data management rules. The video emphasizes the critical role of the TMF in ensuring regulatory compliance, particularly for FDA audits and inspections, and highlights the importance of sponsor oversight and meticulous document management. It also explicitly mentions Veeva as a primary eTMF system that adheres to this filing structure. Key Takeaways: * **TMF Reference Model as Industry Standard:** The DIA TMF Reference Model (version 3.2) serves as the de facto standardized filing structure for clinical trial documentation, crucial for consistency and regulatory adherence across the pharmaceutical and life sciences industries. * **Regulatory Compliance and Audit Readiness:** The TMF is paramount for demonstrating sponsor oversight and ensuring compliance with regulatory bodies like the FDA. Meticulous document management, including version control (e.g., ICF updates) and capturing critical communications (e.g., safety-relevant emails), is essential for successful audits and inspections. * **Veeva's Role in eTMF:** Veeva is explicitly identified as a main eTMF system that largely adopts the TMF Reference Model's filing structure. * **Complexity and Volume of Clinical Documentation:** The video illustrates the immense volume and complexity of TMF documents (e.g., 300+ page CSRs, hundreds of shipping logs per study), highlighting the challenges in accurate classification, quality control, and ensuring completeness. * **Critical Document Types and Their Significance:** Specific documents like the Informed Consent Form (ICF), FDA Form 1572, Clinical Study Report (CSR), and lab certifications (CLIA, CAPA) are highlighted for their regulatory importance and the need for precise handling and review. Understanding these specific document types is crucial for developing targeted AI solutions for document processing and compliance.
MEDIDATA RAVE Training – MEDIDATA RAVE Online Training – (Certification Tips)– MEDIDATA RAVE Course
MaxMunus Training
/@maxmunustraining
Aug 30, 2022
This video provides an overview of Medidata Rave training offered by MaxMunus, detailing the platform's role as a cloud-based Electronic Data Capture (EDC) system critical for managing clinical trial data in the life sciences sector. The speaker explains Medidata Rave's functionality in digitally capturing, handling, and reporting clinical testing data, emphasizing its importance for documenting patient information and accelerating the development of life-enhancing treatments. The training covers fundamental to advanced concepts, features like real-time data entry checks and single sign-on, and the benefits of Medidata Rave certification. The video also highlights the significant global job market for Medidata Rave professionals, with numerous opportunities at leading pharmaceutical, biotech, and CRO companies. Key Takeaways: * **Medidata Rave as a Core Clinical Data Platform:** Medidata Rave is a leading cloud-based EDC system essential for digital data capture, management, and reporting in clinical trials, directly impacting patient information documentation and the efficiency of bringing treatments to market within the life sciences industry. * **High Industry Demand for Expertise:** There is a substantial global demand for professionals skilled in Medidata Rave, with major players in pharma, biotech, and CROs (including companies like Veeva Systems, LabCorp, IQVIA) actively recruiting.ai to integrate its data engineering and AI/LLM solutions. This could involve building robust data pipelines from Rave, developing AI agents to analyze or automate processes related to Rave-managed data, or enhancing compliance tracking for data within such systems.ai can position its AI and data services to augment existing Medidata Rave implementations.
What is a Clinical Trial Manager (CTM) | Salary, Degree Requirements & More
kyyah abdul
/@kyyahabdul
Aug 30, 2022
This video provides a comprehensive overview of the Clinical Trial Manager (CTM) role, detailing their responsibilities, necessary educational background, and salary expectations. The speaker emphasizes that CTMs are crucial for establishing productive vendor relationships, ensuring strict clinical trial compliance with federal and global regulations, and improving the overall efficiency and quality of clinical trial activities. Key duties include overseeing Contract Research Organizations (CROs), managing investigational product sites, participating in study startup, reviewing critical study documents, resolving operational issues, and meticulously preparing and adhering to budgets and timelines. The CTM role is described as a blend of business acumen and scientific understanding, often requiring prior experience as a Clinical Research Associate (CRA). Key Takeaways: * **Central Role in Clinical Operations:** The CTM is a pivotal figure in pharmaceutical and biotech companies, directly responsible for the oversight and successful execution of clinical studies, bridging scientific objectives with operational realities. * **Critical for Regulatory Compliance:** A primary responsibility of the CTM is to ensure clinical trial compliance with federal and global regulations, highlighting the high-stakes environment where regulatory adherence is paramount. * **Complex Vendor Management:** CTMs are deeply involved in managing relationships with various vendors, particularly CROs, requiring strong negotiation, oversight, and problem-solving skills to maintain study timelines and budgets. * **Operational Efficiency and Problem Solving:** The role demands proactive identification and swift resolution of operational challenges to enhance the efficiency, effectiveness, and quality of clinical trial activities, directly impacting study success. * **Data-Driven Decision Making:** The CTM's need to manage study progress, budgets, and timelines implies a reliance on robust data and analytics for informed decision-making and issue resolution.
A Complete Submission Publishing Solution for Life Sciences 2022 Demo
Phlexglobal - a Cencora PharmaLex company
/@Phlexglobal
Aug 17, 2022
This video explores PhlexSubmission, a comprehensive solution for electronic regulatory submissions (eCTD, NeeS, VNeeS) in the life sciences. The speaker demonstrates how the platform streamlines the entire submission lifecycle, from document management and compilation to publishing and validation. Key themes include automation for efficiency, ensuring regulatory compliance, global reach, and user guidance. Throughout the video, the presenter highlights features such as automated eCTD tree creation, intelligent document auto-compilation based on metadata, an integrated 21 CFR Part 11 compliant document management system (Flex DMS), and built-in compliance checks for hyperlinks and PDF properties, often with automatic resolution. The system supports incremental test publishing with integrated FDA eCTD validation (Lorenz validator) and productive publishing, ensuring regulatory adherence. PhlexSubmission also offers capabilities for managing document versions, reusing submissions across different regions, and is delivered as a private SaaS solution, emphasizing global accessibility and unlimited publishing. The "Vera" virtual assistant guides users through complex processes, enhancing user experience and efficiency. Key Takeaways: * **End-to-End Regulatory Submission Management:** PhlexSubmission provides a complete solution covering document management (21 CFR Part 11 compliant), eCTD compilation, publishing, and validation, which is crucial for pharmaceutical and life sciences companies navigating complex regulatory landscapes. * **Automation for Efficiency and Compliance:** The platform leverages automation for eCTD tree creation, metadata-driven document auto-compilation, and automatic detection/replacement of document versions, significantly reducing manual effort and potential errors in regulatory submissions. * **Global Scalability and Reusability:** The system supports managing submissions for multiple health authorities worldwide and allows for easy copying and adaptation of submissions across different regions, enhancing global regulatory strategy and operational efficiency for multi-national life sciences clients. * **User-Centric Design with AI-Assistance:** Features like the personalized user dashboard and "Vera," a virtual electronic regulatory assistant, guide users through complex tasks, making the submission process more accessible and reducing the learning curve, demonstrating a practical application of intelligent assistance in a regulated environment. * **SaaS Model for Accessibility and Flexibility:** Delivered as a private SaaS solution, PhlexSubmission offers web-browser accessibility from anywhere, unlimited test and productive publishing, and readiness for eCTD version 4, providing a flexible and future-proof solution that resonates with modern software development practices.
Is this Stock Better Than Salesforces Inc? | Veeva Systems Inc (NYSE:VEEV)
Learn With Stanley
/@learnwithstanley
Aug 11, 2022
This video provides an investment analysis of Veeva Systems Inc., detailing its origins, core offerings, market dominance, and growth trajectory within the life sciences industry. The speaker explains how Veeva was founded to address the specific cloud-based CRM needs of life sciences companies, which were not adequately met by general platforms like Salesforce. The discussion highlights Veeva's two main ecosystems: the Commercial Cloud, providing CRM and analytical services, and Veeva Vault, a suite of applications for managing clinical trials, industrial regulations, and other critical data points. The video underscores Veeva's position as the de facto cloud service provider for the global life sciences sector, enabling drug companies to develop products, enhance sales and marketing, and ensure regulatory compliance. It also covers Veeva's impressive customer growth, high revenue retention rates, and future revenue projections, attributing its success to a first-mover advantage and the continuous demand for specialized solutions in a highly competitive market. Key Takeaways: * **Specialized Industry Focus:** Veeva Systems' success stems from its targeted approach to the life sciences industry, demonstrating the critical need for specialized cloud-based CRM and data management solutions beyond generic enterprise platforms. * **Comprehensive Platform for Life Sciences:** Veeva offers two key ecosystems: the Commercial Cloud for CRM and analytics, and Veeva Vault for managing clinical trials, regulatory compliance, and other crucial data, covering a broad spectrum of pharmaceutical operations. * **Market Dominance and Entrenchment:** Veeva is identified as the "de facto cloud service provider" for the global life sciences industry, indicating a strong first-mover advantage and significant market share in a highly regulated and specialized sector. * **Addressing Core Industry Needs:** Veeva's solutions directly support drug companies in three vital areas: effective product development and market entry, efficient marketing and sales to healthcare professionals, and maintaining strict compliance with industry and government regulations. * **High Customer Retention and Growth Drivers:** The company's impressive customer growth (over 1,000 customers including major pharma giants) and high revenue retention rates (around 120%) reflect the ongoing demand for its services, driven by intense competition and regulatory requirements within life sciences.
Veeva: Company Details, Growth, & Culture
VentureFizz
/@Venturefizz
Aug 9, 2022
This video explores Veeva Systems' role as the "operating system for Life Sciences," detailing its company structure, growth, and culture through an interview with Steve Harper, SVP Product Management. Veeva, founded in 2007 and serving 47 of the top 50 pharmaceutical companies, offers a combination of software, implementation services, and data services. The discussion highlights Veeva's dual focus on the commercial side of pharma and extensive work in research and development, including drug development, quality processes, clinical trials, and regulatory compliance. A key cultural aspect is their "two in the box" model, pairing technology experts with industry experts to build highly specific and effective products. The video also delves into Veeva's "Digital Trials Platform," aiming to make clinical trials 25% faster and cheaper by 2025 through digitization, and showcases Boehringer Ingelheim as a customer leveraging Veeva's integrated platform across their development process for significant savings and reduced complexity. Veeva's substantial growth, flexible work environment, and recent transition to a Public Benefit Corporation (PBC) status, emphasizing mission-driven work beyond profit, are also discussed as factors attracting talent and customers. Key Takeaways: * **Veeva as the Life Sciences Operating System:** Veeva positions itself as the foundational software platform for the life sciences industry, serving nearly all major pharmaceutical companies with a comprehensive suite of software, services, and data solutions across both commercial and R&D operations. * **Strategic "Two in the Box" Model:** Veeva's core product development and cultural strategy involves pairing technology experts with industry experts. * **Focus on Clinical Trial Digitization:** A major initiative is the "Digital Trials Platform," designed to significantly enhance the efficiency and cost-effectiveness of clinical trials by removing paper-based processes and improving data flow between all participants, aiming for a 25% improvement in speed and cost by 2025. * **Integrated Platform Adoption:** Customers like Boehringer Ingelheim are adopting an "all-in" strategy with Veeva, using its integrated products across their entire development process (clinical, regulatory, quality). This demonstrates the value of a unified platform for reducing complexity and automating data flowai to assist clients with integration and optimization. * **Stability and Mission-Driven Growth:** Veeva exhibits strong growth and stability within the life sciences sector, contrasting with broader tech industry slowdowns. Its conversion to a Public Benefit Corporation (PBC) underscores a commitment to employees, customers, and the community, aligning with a growing industry demand for ethical and impactful technology solutions.
Top 5 Stocks to BUY NOW Part 2 (High Growth Stocks)!
YT Finance
/@ytfinance
Jul 28, 2022
This video, part of a series on top growth stocks, provides an investment analysis of Palantir Technologies, Upstart, and Veeva Systems. While Palantir and Upstart are discussed for their general AI and data analytics capabilities in government/commercial and financial lending sectors respectively, a significant portion of the video is dedicated to Veeva Systems. The speaker highlights Veeva's crucial role as a cloud-based software provider for the pharmaceutical and life sciences industries, emphasizing its use by 18 out of the top 20 pharmaceutical companies. The video positions Veeva as a "defensive" and "recession-proof" stock due to the indispensable nature of its software, which optimizes clinical data management, various operations, regulatory compliance, and customer data analytics within the life sciences sector. Key Takeaways: * **Veeva's Pervasive and Critical Role in Pharma:** The video strongly affirms Veeva Systems as an essential technology partner for the pharmaceutical industry, with its software being "imperative and critical" for daily operations and used by nearly all top pharma companies. * **Stability and Growth in Life Sciences Tech:** The characterization of Veeva as a "recession-proof" company with sustainable demand underscores the inherent stability and growth potential within the life sciences technology sector, particularly for solutions that support critical business functions.