Mergers and acquisitions continue in the CRO industry as companies aim to provide comprehensive trial support services alongside expansive participant recruitment networks. Bioclinica has acquired Compass Research, marking the company’s first foray into the U.S. investigational site network. Financial details of the acquisition were not released.
EMA proposes changes to first-in-human trials spurred by January’s Bial trial deaths
Are the risks faced by phase I clinical trial participants too great? The European Medicines Agency (EMA), the European Commission and the Member States of the European Union (EU) believe so. Together, they’re proposing changes to current guidance on first-in-human clinical trials that would, if successful, improve strategies for identifying and mitigating risks to study subjects. “The purpose of the EMA’s review is to take stock of the evolution of practices in the conduct of first-in-human studies since the guideline that describes first-in-human clinical trials was first published in 2007,” EMA spokesperson Sophie Labbé told CenterWatch.
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