Risk‑Based Monitoring (RBM) represents a proactive and systematic approach to clinical trial oversight, shifting away from ...

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(BMS) recently raised questions with and sought further clarity from the US Food and Drug Administration (FDA) on a draft guidance related to the risk-based monitoring ...

This post is sponsored by IMARC Research, Inc. Since the August 2011 release of the draft guidance document by the FDA on a risk-based approach to monitoring, there has been a lot of buzz in the ...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

New offering improves the quality and predictability of clinical development while reducing overall trial costs by up to 25 percent RESEARCH TRIANGLE PARK, NC – Quintiles today announced the launch of ...

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 ...

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 ...

If most midsize companies have a formal risk management process, why did so many fail even in pre-pandemic years? The problem is that risk heat maps — many companies’ primary tool for assessing risk — ...