James Riddle, MCSE, CIP, CPIA, CRQM

In a complex clinical trial, data monitoring committees oversee interim data to ensure adequate safety monitoring.

Trial designs incorporating multiple endpoints to support efficacy are receiving increased focus from the FDA, including a recently published guidance.

Endpoint adjudication committees must keep up with rapidly developing requirements as they receive potentially identifiable research data.

Ethical oversight committees continue to innovate to keep pace with the rapid changes and evolution of research conduct.

This blog outlines the key elements of a DMC/EAC charter document, explaining its importance in conducting safe and compliant research.

This blog outlines critical events where EACs are used to look at more than just “endpoints” in clinical research.

Take a closer look at how and why we leverage proprietary, custom, and intelligent technology in our EAC program

This blog outlines when a device clinical trial sponsor should engage an EAC or CEC to provide specific medical expertise & safety oversight.

This blog outlines the requirements for each committee, what it does, and the critical roles each plays in keeping research participants safe.