An Analysis of Success Metrics from a Risk-Based Quality Management (RBQM) Approach to Clinical Trial Management

Since the FDA and EMA released guidance on risk-based monitoring in 2013, implementation of the laid-out principles has matured into a RBQM approach. Widespread adoption of RBQM has been slow due to the persistent belief that trial quality can only be achieved with a high degree of source data verification (SDV) and recurring on-site monitoring visits. Other barriers include lack of a standard definition for RBQM across the industry and scarcity of benchmarks demonstrating RBQM benefits. This white paper explores best practices for developing a comprehensive quality management approach that supports RBQM methodologies and reports practical quality measures used to evaluate the overall benefit and impact of such an approach.