Risk-based monitoring (RBM) is transforming how clinical studies are being executed and managed.
Clinical development is at a crossroads - it costs too much and takes too long to develop and bring new therapies to market. With support from the Food and Drug Administration, other global regulatory bodies and industry consortia, risk-based monitoring (RBM) is transforming how clinical studies are being executed and managed. RBM can produce faster, more efficient trials and reduces risks associated with clinical trials by identifying and focusing on the higher risk areas of a study, at both the scientific and operational levels, and utilizes resources accordingly to mitigate those risks. Risk assessment and mitigation drives the strategic and operational plans for the life of the study.