James Riddle, MCSE, CIP, CPIA, CRQM

Find out how the EU AI Act will likely impact clinical research software and systems, and what EU and non-EU entities should do to prepare for compliance.

Using a single Data Safety Monitoring Board for an entire therapeutic program ensures continuity and offers cost savings and efficiency gains.

Find out about the FDA current views regarding DMCs and the 2024 draft guidance’s implications for clinical trial sponsors.

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.