The Department of Clinical Trials executes Phase I, II, and III human clinical trials to the highest ethical and safety standards– fully compliant with GCP,
FDA, and DoD regulations. The department operates with maximum efficiency, multitasking functional areas among job descriptions, new metrics for recruiting efficiencies,
and FDA part 11 CRF compliant electronic databases. Dedicated staffing includes licensed nurses who are also certified clinical coordinators, data managers,
a phlebotomy team and administrative personnel to assist investigators in all trial related activities.
The Pilot Bioproduction Facility (PBF) manufactures clinical grade material for clients. The PBF is a multi-use facility designed and operated for production of
vaccines in compliance with current Good Manufacturing Practices (GMP) regulations. Compliance with cGMP ensures that products prepared in this facility will be safe, potent, and producible.
The PBF follows all federal regulations that apply to biological products and has expertise in the development and production of vaccines for the prevention of a variety of infectious diseases.
Additional capabilities include viral diagnostics and GLP testing.
The Department of Regulatory Affairs provides regulatory guidance and promotes compliance for all product development activities.
Professional regulatory services ensure that submissions are suitable and effective in order to accelerate the development process.
The regulatory affairs team includes medical writers, database managers, regulatory affairs scientists, archivists and biostatisticians.
This team prepares, reviews and maintains regulatory documentation (IND applications, Investigator’s Brochures) to ensure efficient review and approval.