Regulatory changes, including the launch of ICH E6(R3) and Good Clinical Practice (GCP) updates, have highlighted the value of, and need for, risk-based quality management (RBQM) approaches. With benefits including higher quality in clinical trial implementation and lower monitoring costs, the average proportion of clinical trial implementing RBQM is expected to increase to around 80% by 2027.1
So, how has RBQM evolved, what benefits does it offer and what does the future hold?
