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Biotrial Says It 'Rigorously Complied' With Standards In French Phase I Study

This article was originally published in SRA

Executive Summary

Biotrial, the French CRO that conducted the Phase I study of Bial's FAAH inhibitor BIA 10-2474, has taken issue with a government inspection report that questioned its decision to continue dosing of the drug after one of the volunteers was taken to hospital, saying that it applied the precautionary principle and "rigorously complied" with international clinical trial standards1,2.

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