August 2015

Author:
NAMSA Risk-Based Monitoring Working Group:
Therese Everson, MBA
Sharon Herbert, PhD, MBA
Jennifer Mischke, MPH
Tyson Rogers, MS
Katie Schaaf, MS
Jill Visor, MS

Abstract:

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.