What's Needed: An Alternative Approach To Clinical Trial Management
Risk-Based Monitoring. Risk-Based Execution. Risk-Based Quality Management. The monitoring and management of clinical trials are called many things—yet, they are, in fact, different. FDA Director of the Office of Scientific Investigations, David Burrow, notes that “Risk-based quality management is not just risk-based monitoring.” RBQM is a more substantial undertaking, requiring quality, reliability, and interpretability. It is achieved through a combination of risk assessment, appropriate protocols, and risk-based monitoring. And to be successfully implemented, it demands planning, based on proper assessments, with mitigation, escalation, and remediation strategies. Regulators want to see clinical trials implementing this approach. Yet, sponsors and contract research organizations (CROs) are finding it challenging. It doesn’t have to be.
Get unlimited access to:
Enter your credentials below to log in. Not yet a member of Clinical Leader? Subscribe today.