Technologies that improve site, sponsor and CRO execution of studies by Veeva Systems

This presentation, delivered by Veeva Systems representatives, explores the critical role of technology and philosophical shifts in optimizing the execution of clinical trials for sites, sponsors, and CROs, with a strong emphasis on adapting to increasing trial complexity and the accelerated virtualization driven by the COVID-19 pandemic. The core message is that technology must evolve from being a limiting factor to providing flexible, future-proof foundations that support adaptive trials and decentralized models. The speakers highlight that the average database build time (nearly 70 working days) and the resulting delays in data entry and database lock are unacceptable, especially given that studies not ready before First Patient First Visit (FPFV) experience significantly worse outcomes.

To address these inefficiencies, Veeva advocates for five principles of agile design: standards and reuse, fusing design and specification, configuration over custom programming, collaborative User Acceptance Testing (UAT), and simplified amendments. The goal is to reduce database build times to four to six weeks, or even days for urgent needs like COVID-19 trials. The methodology involves moving away from traditional waterfall processes, where specifications are written offline and then programmed, toward a visual, self-documenting build environment (Veeva Studio). This allows study teams to build and review the system iteratively, eliminating the lengthy "ping-pong" cycle of testing and fixing, and enabling real-time, collaborative UAT.

The presentation provides concrete examples of simplification, such as using reusable event groups and a powerful, configurable rules engine to manage complex protocols. For instance, an oncology trial with 32 cycles was reduced to two reusable groups by using dynamics to conditionally add forms and events based on patient criteria, minimizing programming effort. Furthermore, the speakers discuss the importance of the "Diff Report," a tool that compares study versions or standards, enabling teams to adopt a risk-based approach to UAT by focusing testing efforts only on the elements that have changed. This focus on architectural flexibility also allowed Veeva to rapidly deploy configurable objects, such as a "COVID-19 reason" field, across existing studies to document missed procedures without requiring system downtime or custom code migration.

Key Takeaways:

• Prioritize Database Readiness for FPFV: Studies where the database is not ready before FPFV experience significantly longer data entry times (doubling) and database lock times (increasing by 60%), underscoring the necessity of reducing average build times from 70 days to four to six weeks.
• Adopt Configuration for Complexity: Utilize a robust rules engine to handle complex study logic (e.g., dynamic form display, conditional event addition) through configuration rather than custom programming (C# or Java), which introduces rigidity, delays, and risk during subsequent protocol amendments.
• Simplify Protocol Amendments: Technology must support simplified amendments that do not require full database migrations or system downtime. Changes should be applied prospectively (for new patients) or retrospectively (for existing patients) by simply appending the new design version to the existing data structure, eliminating data loss risk.
• Implement Risk-Based UAT: Leverage automated differential reporting tools to compare study designs against standards or prior versions. This allows UAT efforts to be focused solely on the components that have changed, drastically accelerating the testing and approval cycle.
• Leverage Standards for Speed: Aggressively utilize reusable components (forms, items, event groups) and industry-standard templates (e.g., those based on FDA guidance for COVID-19) to accelerate study builds, enabling rapid deployment in days rather than weeks.
• Foundational Architecture Enables Agility: Ensure the underlying technology architecture is flexible and extendable, allowing for the swift introduction of new features (like COVID-19 data fields or decentralized trial capabilities) as configurable objects without requiring extensive custom development or system downtime.
• Empower Sites with Dedicated Technology: Provide sites with free, purpose-built tools, such as an e-reg binder (SiteVault), to improve site engagement, standardize document management, and facilitate remote Source Data Verification (SDV), a critical need during decentralized operations.
• Fuse Design and Specification: Move the specification process into the visual build environment (Studio) so that documentation is self-generated as the system is built. This eliminates the lengthy, sequential waterfall process of writing, programming, and then testing specifications.
• Ensure Data and Document Connectivity: The foundational architecture must support seamless Clinical Data Exchange, ensuring real-time visibility and sharing of both data (EDC) and documents (eTMF, e-reg binder) across sponsors, CROs, and sites.

Tools/Resources Mentioned

• Veeva Vault EDC/CDMS: The core clinical data management system.
• Veeva Vault Studio: The visual, self-documenting build environment for EDC design.
• Veeva Vault SiteVault: A free e-reg binder and document management solution for clinical sites.
• Diff Report (Differences Report): A tool used to compare study versions or standards to identify changes for focused UAT.

Key Concepts

• Agile Design Principles: A methodology for EDC build emphasizing iterative development, collaboration, configuration, and continuous review.
• Self-Documenting Specification: The process where building the study design in the system automatically generates the necessary specification documentation.
• Clinical Data Exchange: An architectural concept promoting seamless sharing of data and documents across all stakeholders in a clinical trial.