SUCCESSFUL THIRD-PARTY AUDIT OF BIOTRIAL’S US CLINICAL PHARMACOLOGY UNIT
July 5th, 2016 – New Jersey, USA
Biotrial is pleased to share the results of a successful thorough audit of our Clinical Pharmacology Unit (CPU) in Newark, New Jersey. Following a recent third-party audit, the systems, operations and staff at our facilities were found to be in compliance with applicable FDA regulatory requirements, procedural documents and industry standards.
The audit was conducted over a two-day period and included an overview of the organization and personnel as well as a tour of the facilities. The scope of the audit encompassed a review of quality management systems, equipment maintenance, calibration and use, facility records, medical monitoring and computer systems. The auditors also covered project management, subject recruitment, screening and consent, clinical operations, drug receipt, storage, dispensing and accountability, data recording, document management and investigator responsibilities.
Biotrial’s COO, Nicolas Fauchoux, commented: “Since setting up the unit earlier this year, we’ve had numerous sponsors come and audit our organization. These audits allowed us to confirm that our setup is in line with current regulations, guidelines and business practices. However, the outcomes of these audits are confidential.” Following the independent audit and report, Biotrial now has “A professional, detailed and independent audit report that we can share with our clients who request it”.
The 110-bed Phase I unit was designed for all types of Early Development studies, including but not limited to: First-in-Human Trials, Pharmacodynamic Studies, Food Interaction Trials, Drug-Drug Interaction Studies, Bioequivalence and Bioavailability Trials. The facilities house a state-of-the-art EEG and Sleep Study ward as well as specialized spaces for cognitive testing.
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