Aardvark Therapeutics, Inc. (Aardvark) (Nasdaq: AARD), a clinical-stage biopharmaceutical company focused on developing novel, small-molecule therapeutics to activate innate homeostatic pathways for ...
As the curtain closed on 2024, FDA issued a new draft guidance to assist clinical trial sponsors, investigators, and institutional review boards (“IRBs”) with defining, identifying, and reporting ...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 clinical trial process is broken for a variety of reasons, ranging from the difficulty of designing trial protocols to the cost of running them. But one critical (and solvable) issue is finding, ...
Artificial intelligence (AI) offers a new path forward for clinical trial sponsors, contract research organizations (CROs), and research sites collaborating on trials. By replacing reactive protocols ...
The U.S. Food and Drug Administration (FDA) published the draft guidance “Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices,” which provides advice for ...
Dyne Therapeutics has announced a revised protocol for its ACHIEVE trial, elevating video hand opening time (vHOT) to the primary endpoint for U.S. Accelerated Approval of DYNE-101, a treatment for ...
The Annual Outsourcing in Clinical Trials & Clinical Trial Supply Nordics 2025 conference will gather experts to discuss ...