Having inked the contract Technical Resources International (TRI) will provide a range of services to support research into HIV. For the services TRI has received an initial $9.0m (€7.0m). Over the next seven years the contract has a potential total value of $75.3m.
In exchange TRI will review protocol documents and prepare and file investigational new drug (IND) applications. TRI will also review existing INDs in compliance with regulatory procedures, assess informed consents and process essential documents for protocol registration.
Other tasks covered by the contract include the collection, processing and preparation of adverse event reports for the US Food and Drug Administration (FDA).
The contract was awarded by the US National Institute of Allergy and Infectious Diseases (NIAID). More specifically, TRI will provide services to clinical research programmes supported by the Division of Acquired Immunodeficiency Syndrome (DAIDS), a unit of the NIAID.
DAIDS is working to advance research into the pathogenesis and transmission of HIV. This entails sponsoring Phase I to IV clinical trials to assess the safety and efficacy of therapeutics, vaccines and other preventive measures.
The contract expands on the existing relationship between TRI and the NIAID. In June, TRI, along with its subcontractor Icon, signed a contract with the NIAID which could be worth $171m over the next seven years.
Under the terms of the earlier contract TRI and Icon provide services to the Division of Microbiology and Infectious Diseases (DMID), which supports research into “virtually all human infectious agents except HIV”.
Nora Lee, CEO of TRI, said: "TRI is ready and eager to continue the mission-critical support services we currently provide to NIAID.”