Key Considerations in the Transition to Risk-Based Monitoring

Area of Science:

• Clinical Trials
• Pharmaceutical Science
• Regulatory Affairs

Background:

• The European Medicines Agency and US Food and Drug Administration have issued guidance on risk-based quality management and monitoring.
• Risk-based monitoring (RBM) methodologies, products, and services have rapidly evolved and diversified.
• The biopharmaceutical industry faces numerous choices for RBM approaches and practices.

Purpose of the Study:

• To provide a framework for biopharmaceutical companies to select and implement risk-based monitoring (RBM).
• To assist companies in choosing appropriate RBM service providers.
• To guide the strategic adoption of RBM in clinical trials.

Main Methods:

• The framework discusses various approaches to source data verification (SDV).
• It addresses critical dimensions of RBM beyond SDV.
• Key elements include study-specific monitoring, real-time quality management, and error prevention.

Main Results:

• The article outlines a structured approach to RBM selection and implementation.
• It emphasizes the importance of tailoring RBM to individual study needs.
• The framework integrates error detection, correction, prediction, and prevention strategies.

Conclusions:

• A systematic framework is essential for effective RBM adoption.
• Companies can optimize clinical trial quality and efficiency through strategic RBM implementation.
• Selecting the right RBM approach and provider is crucial for successful clinical investigations.