Understanding TSDV vs RBQM: Evolving Toward Dynamic, Risk-Based Monitoring
The industry’s transition from Traditional Source Data Verification (TSDV) to true Risk-Based Quality Management (RBQM) represents a strategic transformation in how quality, safety, and efficiency are achieved in clinical trials.
In this expert panel discussion, leaders from Astellas Pharma, Bayer, and Syneos Health explore what this evolution looks like in practice. They share real-world experiences moving away from 100% SDV toward targeted SDV (TSDV), targeted SDR, and dynamic site monitoring strategies that leverage centralized data, automation, and quality tolerance limits.
You’ll learn how:
- Astellas successfully eliminated full SDV in favor of adaptive SDR sampling strategies, integrating CluePoints technology to automate site quality assessments.
- Bayer developed a unified visualization environment to identify and address site risks in real time.
- Syneos Health applies holistic monitoring approaches to drive proactive, data-informed site engagement across studies.
The discussion extends beyond the definitions of TSDV vs. RBQM, offering practical insights into stakeholder buy-in, regulatory alignment, technology integration, and measurable efficiency gains. Discover how leading organizations are redefining monitoring models to reduce redundancy, focus on what truly matters, and build a more resilient, risk-based future for clinical operations.
