Pfizer and Bristol-Myers Squibb (BMS) recently raised questions with and sought further clarity from the US Food and Drug Administration (FDA) on a draft guidance related to the risk-based monitoring ...

This post is sponsored by IMARC Research, Inc. Since the August 2011 release of the draft guidance document by the FDA on a risk-based approach to monitoring, there has been a lot of buzz in the ...

The US Food and Drug Administration (FDA) on Tuesday issued final guidance meant to assist drug and medical device makers in developing risk-based monitoring strategies for clinical investigations ...

In today's ACT Brief, we examine the technical and operational challenges of implementing risk-based monitoring across global trials, how AI must address social determinants of health and site burden, ...

Bethesda, MD (Oct. 17, 2025) — The American Gastroenterological Association (AGA) today released a new clinical practice guideline on the surveillance of Barrett's esophagus, the only known precursor ...

Organizations are integrating previously disparate services to better align their offerings with the shift from fee-for-service to risk-based care through visionary, member-centric solutions. For ...