This post is sponsored by IMARC Research, Inc. Since the August 2011 release of the draft guidance document by the FDA on a risk-based approach to monitoring, there has been a lot of buzz in the ...

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(BMS) recently raised questions with and sought further clarity from the US Food and Drug Administration (FDA) on a draft guidance related to the risk-based monitoring ...

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 this free webinar, gain insight into the key elements to reduce risk for clinical trials. Attendees will learn how Independent Review and Data Analytics in eCOA strengthen endpoint integrity and ...

Clinical trials can often take between six and seven years to complete, but that timeline isn’t always practical for the problems pharmaceutical companies are trying to solve. Additionally, six years ...

The U.S. Food and Drug Administration (FDA) recently finalized its guidance, “A Risk-Based Approach to Monitoring of Clinical Investigations” (the “2023 RBM Guidance”) which follows up on the Agency’s ...

WASHINGTON--(BUSINESS WIRE)--This week, the Association of Clinical Research Organizations (ACRO)’s RBQM Working Group published a paper in DIA’s Therapeutic Innovation & Regulatory Science journal ...