By ACRO’s CRO Forum’s RBQM Working Group
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) principals 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 which supports key decisions that will manage clinical trial complexity.