Transforming Clinical Trials with Risk-based Quality Management (RBQM)

Clinical trials are becoming more complex due to the adoption of decentralized models, increasing data volumes, and greater regulatory scrutiny. Conventional approaches centered on 100% Source Data Verification (SDV) and uniform on-site monitoring are inefficient, costly, and slow at detecting emerging risks.

RBQM addresses these limitations through a comprehensive, risk-focused framework. Anchored in principles such as Quality by Design (QbD), centralized monitoring, and continuous risk assessment, RBQM empowers sponsors to identify, prioritize, and mitigate critical risks across all trial phases. The approach enhances trial quality, accelerates timelines, and ensures compliance with global regulatory standards, including FDA, EMA, and ICH E6 (R3).

This report outlines the evolution from Risk-based Monitoring (RBM) to RBQM, presents the core principles and key components of RBQM, and offers guidance on how enterprises can derive success from their RBQM initiatives. It is intended for sponsors and Contract Research Organizations (CROs) seeking to modernize trial oversight and improve operational performance through data-driven quality management.