List of terms commonly used in clinical trial research. Glossary of Medical Terms in Lay Language Helpful list of medical terms described in lay language. Sample Study Startup Checklist Use this ...
As the curtain closed on 2024, FDA issued a new draft guidance to assist clinical trial sponsors, investigators, and institutional review boards (“IRBs”) with defining, identifying, and reporting ...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 newly introduced AI-powered study build engine marks the first phase of ClinCapture's broader intelligent trial roadmap. By automating protocol translation, Captivate establishes a foundation for ...
Most protocol deviations start as human problems, not operational ones, but risk-based monitoring typically relies on lagging ...
The U.S. Food and Drug Administration (FDA) published the draft guidance “Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices,” which provides advice for ...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 ...
In the second of a two-part article, Gabrielle Faure-André and Stéphanie Garçon at Santarelli unpick EPO, UPC and French case law to assess the importance of clinical development timelines in ...
In the first of a two-parter, lawyers at Santarelli analyse the patentability of therapeutic inventions where publication of clinical trial protocols occurs before the application's filing date The ...
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