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TRI to Provide Regulatory Support Services to the National Institute of Allergy and Infectious Diseases

Tuesday, August 17, 2010 Medico Legal News J E 4
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BETHESDA, Md., Aug. 17 Technical Resources International, Inc. (TRI) is pleased to announce that TRI has been awarded the Regulatory Support Center (RSC) contract by the U.S. National Institute of Allergy and Infectious Diseases (NIAID) of the U.S. National Institutes of Health (NIH), Department of Health and Human Services (DHHS). An initial award of $8,989,333 million was received; the contract has a potential total value of up to $75,304,348 over 7 years.

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Under the RSC contract, TRI will continue to provide the full range of clinical, regulatory, and operational support for all domestic and international clinical research programs supported by NIAID's Division of Acquired Immunodeficiency Syndrome (DAIDS). TRI will review protocol documents and prepare and file new Investigational New Drug (IND) applications and amendments to existing INDs in compliance with regulatory procedures; review informed consents and process all essential documents for protocol registration; collect, process, and prepare adverse events reports for transmittal to the FDA, if required.

In addition to its responsibilities as sponsor of INDs, NIAID arranges for the provision of investigational drug and vaccine products for clinical trials that are sponsored by pharmaceutical and biotechnology companies.

NIAID supports research connected to the basic comprehension of microbiology and immunology leading to the development of vaccines, therapeutics, and medical diagnostics for the prevention, treatment, and diagnosis of infectious and immune-mediated diseases.

NIAID is working to end the HIV/AIDS epidemic by advancing basic knowledge of the pathogenesis and transmission of HIV, supporting the improvement of therapies for HIV infection and its complications, and supporting the development of HIV/AIDS vaccines and other prevention measures. NIAID sponsors Phase I, II, III and IV clinical trials to assess the safety and efficacy of therapeutics, vaccines, and other preventive modalities. Currently, NIAID funds more than 300 HIV/AIDS clinical trials in more than 50 countries at more than 1,000 domestic and international clinical research sites.

Commenting on the contract award, Nora Lee, TRI's President and CEO expressed, "TRI is ready and eager to continue the mission-critical support services we currently provide to NIAID. 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."

About TRI: Technical Resources International, Inc. is a full-service contract research organization. TRI's areas of expertise include regulatory affairs, clinical trials management, medical writing, safety & pharmacovigilance, quality assurance, information technology, and communications. For over 30 years, TRI has provided support to government agencies, the private sector, and non-profit organizations. Further information is available at www.tech-res.com.

SOURCE Technical Resources International, Inc.
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