Risk-Based Monitoring (RBM) Implementation: Challenges and Potential Solutions.

Risk-based monitoring (RBM) has disrupted the clinical trial industry, challenging conventional monitoring norms, business processes, and organizational structures. Endorsed by regulators and leading industry forums, and further driven by escalating drug development costs and enabling technology shifts making data available real time, the industry is moving from a mode of recalcitrance to acceptance. The effective implementation of RBM requires delicately interweaving changes in technology, processes, people, and perspectives. This article deliberates upon the multiple challenges that exist and proposes potential solutions.