A risk-based approach to clinical monitoring has been supported by the Food and Drug Administration (FDA), European Medicines Agency (EMA) and others as a new way to facilitate more efficient trial delivery without compromising data quality or patient safety.

Quintiles has created Data-driven Trial Execution, a delivery model based on risk-based monitoring principles and processes that helps sponsors better mitigate a trial’s highest potential risks. By harnessing the power of integrated, holistic data, we’re able to respond to signals and trends that could affect patient safety and operational performance and help make smarter decisions about which sites to select and how to deploy monitoring resources. Combining risk-based thinking, data analytics and years of process refinement has enabled this evolution of to deliver greater efficiencies and more predictable trial outcomes.