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 ...

The American Gastroenterology Association (AGA) Institute issued new clinical practice guidelines, providing evidence-based recommendations for managing hepatitis B reactivation (HBVr) in at-risk ...

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(BMS) recently raised questions with and sought further clarity from the US Food and Drug Administration (FDA) on a draft guidance related to the risk-based monitoring ...

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 ...

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 ...