Dive Brief:
- Biotrial of France has opened its North American headquarters in New Jersey, a 110-bed Phase 1 unit designed for early development studies at the University Heights Science & Technology Park in Newark, NJ.
- The company also announced a successful third party audit of the clinical pharmacology unit in which the facility and staff were found to be in compliance with applicable FDA regulatory requirements.
- Biotrial is trying to move on from a tragic Phase 1 study in France that left 6 volunteers hospitalized with severe neurological side effects, and one death. The safety drug trial is still under investigation.
Dive Insight:
Biotrial’s new facility in Newark is a key component of its early development focus. The building is slated for such studies, including first-in-human trials, pharmacodynamics studies, food interaction trials, drug-drug interaction studies, bioequivalence and bioavailability trials. The facilities also will house EEG and sleep study ward, and specialized spaces for cognitive testing.
The Newark Clinical Pharmacology Unit also received word of a successful third-party audit, the company said. The company said its systems, operations and staff at their facilities were found to be in compliance with Food and Drug Administration requirements, procedural documents and industry standards. The audit lasted two days and also included a tour of the facilities.
Biotrial Chief Operations Officer Nicolas Fauchoux said the "audits allowed us to confirm that our setup is in line with current regulations and business practices."