Firm will offer clinical, regulatory, and operational support for all domestic and overseas projects.
CRO Technical Resources International (TRI) has won an initial $8,989,333 Regulatory Support Center (RSC) contract from NIH under which it will continue to provide its services to the agency’s National Institute of Allergy and Infectious Diseases. The contract has a potential overall value of up to $75.3 million over seven years.
Under terms of the agreement TRI’s DAIDS Regulatory Support Center will provide a full spectrum of clinical, regulatory, and operational support for all domestic and overseas clinical research programs supported by NIAID’s division of acquired immunodeficiency syndrome. This spectrum of services will include reviewing protocol documents, preparing and filing IND applications and IND amendments, reviewing informed consents, and processing all essential documents for protocol registration. The firm will in addition collect, process, and prepare adverse events reports for transmission to FDA.
“Part of TRI’s corporate philosophy is to continually strive to improve our clients’ deliverables, something we have achieved and will continue to perform under this contract,” remarks Nora Lee, TRI’s president and CEO.
Founded in 1979, TRI provides a full range of support services to private industry, government agencies, and associations. The group’s health services business includes biopharmaceutical development support, health information services, and health/environmental assessment. The biopharmaceutical development group is focused on providing resources to expedite the development and commercialization of new drugs. Areas of expertise include clinical research support, regulatory affairs, quality assurance, and safety and pharmacovigilance.
In June TRI and its subcontractor Icon Clinical Research were awarded an initial $19 million clinical research operations and management support (CROMS) contract by the NIAID. The overall deal has a potential total value of up to $171million over seven years. Under terms of the CROMS contract, TRI and Icon will provide NIAID’s division of microbiology and infectious diseases with support for protocol development, clinical site monitoring, training, pharmacovigilance, the CROMS information data system, and quality management.