Risk-Based Monitoring: A Cognizant Approach

Conducting clinical trials in today’s environment of evidence-based data requirements combined with reduced funding and day-to-day budget constraints is forcing Sponsors and CROs to take a more efficient approach to implementing and managing their clinical studies. This, in combination with FDA’s guidance document on risk-based monitoring and the European Medication Agency’s (EMA) reflection paper on risk-based quality management in clinical trials, has lent momentum to a movement that addresses one of the most expensive budget line items—clinical trial monitoring—in creative ways, including risk-based monitoring.

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