Efficient Positioning of QTL and Secondary Limit Thresholds in a Clinical Trial Risk-Based Monitoring.

In the high-stakes world of clinical trials, where a company's multimillion-dollar drug development investment is at risk, the increasing complexity of these trials only compounds the challenges. Therefore, the development of a robust risk mitigation strategy, as a crucial component of comprehensive risk planning, is not just important but essential for effective drug development, particularly in the RBQM (Risk-Based Quality Management) ecosystem and its component-RBM (Risk-Based Monitoring). This emphasis on the urgency and significance of risk mitigation strategy can help the audience understand the gravity of the topic.

Efficient Risk Mitigation Planning for a Clinical Trial.

Each clinical trial faces numerous risks. Neglecting or reacting spontaneously at each materialized risk may delay trial completion, affect trial objectives and even derail the clinical trial. At the same time, pre-allocating excessive contingency resources to eliminate all potential risks, even with a low probability of occurrence and impact, may not be necessary.