As the curtain closed on 2024, FDA issued a new draft guidance to assist clinical trial sponsors, investigators, and institutional review boards (“IRBs”) with defining, identifying, and reporting ...
The U.S. Food and Drug Administration (FDA) published the draft guidance “Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices,” which provides advice for ...
The integration of real-world data (RWD) into protocol feasibility and site selection has emerged as a clinical trial game-changer in recent years. Traditionally relying heavily on data from carefully ...
The evolution of clinical research has been dependent on the conversion of Healthcare Organizations (HCOs) to clinical research sites, along with the conversion of Healthcare Providers (HCPs) to ...
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