Speeding the Switch to Risk-Based Monitoring


Since the U.S. Food and Drug Administration (FDA) published its industry guidance "Oversight of Clinical Investigations - A Risk-Based Approach to Monitoring" 1 in August 2013, the topic has taken the industry limelight, as companies strive to develop the best approaches and overcome challenges. The intent of risk-based monitoring (RBM), a paradigm shift in the way clinical trials are monitored, is to enhance patient safety, improve the quality of clinical data, and drive efficiencies.

The adoption of RBM is increasing as companies provide greater management support, staff training and more sophisticated technology systems. Technology platforms that enable continuous monitoring with near real-time intuitive visualizations, analytic dashboards and applications will allow issues to be identified and addressed early, improving study safety and efficiency.

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