The company – most recently in the headlines after one volunteer died and five others were hospitalized during a Phase I clinical trial conducted by the CRO – opened the new 60,000sq.ft. facility in Newark, New Jersey’s University Heights Science & Technology Park (UHSTP).
The park includes five universities and other biomedical organizations, including the New Jersey Institute of Technology’s Enterprise Development Center and its 90 incubator companies.
The 110-bed Phase I unit was designed for various early development studies, including first-in-human (FIH) trials, pharmacodynamic studies, food interaction trials, drug-drug interaction studies, and bioequivalence and bioavailability trials.
The facilities feature an EEG and sleep study ward in addition to areas for cognitive testing.
The company announced a successful third-party audit of the Clinical Pharmacoogy Unit in July, during which the facility and its staff were found to be in compliance with applicable FDA regulatory requirements.
According to the company, 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.
Biotrial’s COO, Nicolas Fauchoux, commented in the company’s release: “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.”
As listed on the company’s website, Biotrial is currently hiring for several positions at the location, including a director of business development, clinical research pharmacy manager, core lab EEG technician, and clinical project manager.
Biotrial did not respond to a request for comment.