BIOTRIAL BIOANALYTICAL SERVICES: THIRD SUCCESSFUL FDA AUDIT IN A ROW
June 17th, 2016 – Laval, Quebec, Canada
Biotrial Bioanalytical Services (BBS) received a surprise visit by the FDA at the beginning of June and is pleased to announce that it is the third audit in a row where no form 483 has been issued at the end of the review. The audit involved thorough review of SOPs, study-related documents, security of the data, software validation as well as general facility documents. The auditor focused on documents relating to clinical studies.
Once again, the interactions with the FDA inspectors were important as they provide us with precious feedback on our work performed. BBS is extremely pleased to have had the excellent quality of our work confirmed by the FDA for the third time in three years.
BBS offers high-quality bioanalytical services from discovery through all phases of early and late clinical development. Our experts are available to assist sponsors in developing even the most challenging assays, for both large and small molecules using LC-MS-MS and Ligand Binding and through all stages of development.
Founded in 1989 and specializing in Early Development, Biotrial provides solutions from in-vivo pharmacology through early clinical development to proof of concept, bringing a wealth of expertise to the study design process. With locations in Rennes, Mulhouse (Basel area), London, Montreal and New Jersey, Biotrial’s service lines include Non-Clinical Pharmacology, Phase I, Patient Studies, Bioanalysis, ECG & Imaging Core Lab (QT/QTc Trials, Psychometric Testing, Imaging, EEG/PSG Assessment), Oncology, Data Management, Biostatistics, Medical Writing, Quality Assurance & Regulatory Affairs.
For more information, visit www.biotrial.com