Developing, executing, and overseeing clinical trials is a complex process. Gaining reliable evidence from clinical trials is essential for appropriate decision-making activities regarding trial participants’ safety and the reliability of trial results. As clinical trials have become more complex, the clinical trial process has faced significant operational challenges. As a result, sponsors must identify proactive ways to design quality into the study design rather than taking the reactionary approach of monitoring quality into clinical trials.
Risk-Based Quality Management (RBQM) rooted in Quality by Design (QbD) principles while applying Risk-Based Monitoring (RBM) control mechanisms offers such a solution. This systems-wide approach encourages cross-functional engagement in a holistic and risk-based approach to clinical trial management and oversight. Ultimately it will be that framework that supports key decisions that will manage clinical trial complexity.