An Integrated Risk-­Based Monitoring Solution

By Comprehend Systems

Effective monitoring of clinical trials is critical to conducting high-­‐quality studies that ensure the integrity of study processes and data and the safety of subjects. To help trial sponsors achieve this requirement, the U.S. Food and Drug Administration (FDA) issued final guidance on clinical trial monitoring and European Medicines Agency (EMA) issued updated guidance in 2013 encouraging sponsors to take a more proactive approach to clinical development to ensure compliance and mitigate risks. The guidance promotes a risk-­‐based approach to trial monitoring, strongly supporting the use of advanced technology for centralized trial management.