Interview with Pinar Bérénice Bénet, Veeva

This video provides an in-depth exploration of the challenges and solutions facing clinical trial sponsors under the new ICH E6(R3) guidelines, focusing on transforming clinical oversight from retrospective reviews to continuous, predictive, and data-driven accountability. Pinar Bénet, Senior Director of GTM Strategy and Clinical Lead at Veeva Systems, discusses how the industry must adapt to R3's definition of essential records, which now includes operational data, communications, and metadata, not just static documents. The central theme revolves around ensuring sponsors have timely, meaningful oversight evidence, particularly in highly outsourced environments where distinguishing between data noise and actionable insights is critical.

A major focus of the discussion is addressing the data transfer and ownership challenges inherent in sponsor-CRO relationships. Veeva addresses this by equipping CROs with a "CTMS Transfer" bridge, which facilitates the daily delivery of operational oversight data directly to the sponsor’s CTMS environment. Bénet also notes a growing market trend where sponsors, while remaining heavily outsourced for execution, are choosing to "in-house" their data management systems (like EDC) to maintain control over data standards and quality. This shift is enabled by modern, modular, and user-friendly applications like Veeva’s, which significantly reduce the learning curve compared to legacy solutions, allowing sponsors who are new to owning their EDC to gain control quickly.

The interview delves into the organizational and cultural biases that hinder the shift toward proactive quality by design (QbD). Bénet argues that the biggest obstacle is the industry’s legacy reliance on "waterfall" methodologies—linear, rigid processes often embedded in legacy software. This approach stifles agility, collaboration across departments, and the rapid implementation of study amendments. To truly embrace R3, sponsors must adopt agile ways of working, which necessitates agile systems that facilitate collaboration and allow for rapid changes without requiring costly and complex database migrations, a common issue given the average clinical trial involves ten to fifteen amendments.

Finally, the discussion covers balancing regulatory defensibility with R3’s intent for proportional quality management. Bénet emphasizes that proportionality means evaluating each study individually to create a personalized, risk-based plan, rather than applying a standardized, over-engineered set of compliance steps to every trial. This forces sponsors off "autopilot" and requires active decision-making about where to invest resources. Furthermore, to enable cross-functional accountability—a core tenet of R3—digital platforms must be connected and unified, allowing relevant functions (with appropriate security) to access processes, data, and documents immediately to collaborate, thereby improving overall quality through shared visibility and teamwork.

Key Takeaways:

• Shift to Continuous Oversight: R3 mandates a transformation from retrospective quality assurance to continuous, predictive, data-driven accountability, requiring sponsors to treat operational data, comms, and metadata as essential records.
• Timely Data is Paramount: Sponsors cannot act on risks without timely data. Veeva addresses this in outsourced models using the CTMS Transfer bridge, which ensures operational oversight data is delivered daily from the CRO’s CTMS to the sponsor’s environment.
• Insourcing Data Management: A growing number of sponsors are bringing their data management systems (like EDC) in-house while still outsourcing execution to CROs, allowing them to control data standards and gain greater oversight control.
• Agile Systems for QbD: The biggest organizational hurdle is the legacy mindset and systems built on "waterfall" logic. Proactive quality by design (QbD) requires agile systems that support collaboration, rapid amendments, and quick deployment of changes to sites.
• Proportionality in Compliance: Sponsors must move away from over-engineering compliance. R3 requires them to evaluate each study individually to develop a personalized, risk-based plan, investing resources where risks are highest rather than repeating standardized actions across all studies.
• Data Lineage and Transparency: In the complex ecosystem involving sponsors and CROs, sponsors need the ability to trace data lineage across all systems the data travels through, whether those systems are owned by the sponsor or the CRO.
• Risk of Disconnect in Outsourcing: Fully outsourced sponsors face the greatest inspection risk under R3, often misunderstanding how to execute continuous oversight. A major missing element is a standardized, industry-wide approach for codifying and replicating oversight execution.
• Quality as a Function of Accountability: Achieving a culture of quality (as emphasized by ICH R2/R3) is enabled by digital platforms that foster cross-functional accountability. Unified platforms allow teams to collaborate on the same processes, data, and documents, improving quality through shared visibility.

Tools/Resources Mentioned:

• Veeva Systems: The platform provider discussed throughout the interview.
• Veeva Clinical Platform: The overarching suite of connected applications.
• Veeva CTMS Transfer: A specific bridge enabling operational data transfer from CRO to sponsor CTMS.
• Veeva CTMS (Clinical Trial Management System)
• Veeva eTMF (electronic Trial Master File)
• Veeva EDC (Electronic Data Capture)
• Veeva CDB (Clinical Data Base)
• Veeva RTSM (Randomization and Trial Supply Management)
• Veeva eCOA (electronic Clinical Outcome Assessment)

Key Concepts:

• R3 (ICH E6(R3)): The latest revision of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use guideline, emphasizing quality by design, risk-based quality management, and continuous oversight.
• Continuous Oversight: The practice of monitoring clinical trial performance and data quality in real-time or near real-time, moving away from periodic, retrospective reviews.
• Waterfall vs. Agile: Waterfall refers to a linear, sequential development process (common in legacy pharma software), while Agile refers to flexible, collaborative, and iterative processes necessary for rapid adaptation and quality by design.
• Proportional Quality Management: The principle under R3 that requires sponsors to tailor their quality management efforts and investments based on the specific risks entailed by an individual clinical research study.