Occupational and environmental health and safety (OEHS) training has long been a central element of regulatory compliance and organizational risk management. Globally, employers invest substantial ...

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 ...

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(BMS) recently raised questions with and sought further clarity from the US Food and Drug Administration (FDA) on a draft guidance related to the risk-based monitoring ...

This post is sponsored by IMARC Research, Inc. Since the August 2011 release of the draft guidance document by the FDA on a risk-based approach to monitoring, there has been a lot of buzz in the ...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

David Benigson is CEO of Signal AI, a company using AI and media data to help executives cut through noise and drive actionable insights. Risk is no longer a four-letter word—it's a critical factor ...

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 ...

If you’re running a quality building — strong staffing ratios, engaged leadership, residents thriving — you know the frustration. One abuse scandal three states away, and suddenly your census takes a ...