A Medical Device Daily
Science Applications International (SAI; San Diego) reported it has been awarded a contract from the Department of Health & Human Services, National Institutes of Health (NIH), to provide regulatory affairs support to the National Institute of Allergy and Infections Diseases, Division of Microbiology and Infectious Diseases (DMID; Bethesda, Maryland). The contract has a seven year period of performance and a total value of more than $19 million. Work will be performed primarily at SAIC offices in Frederick, Md.
DMID supports research to treat and prevent diseases caused by virtually all human infectious agents. It manages a wide variety of projects including the development and clinical evaluation of new drugs, vaccines, and diagnostics.
Under this contract, SAIC will provide regulatory expertise, and technical and administrative support for clinical research programs. Additional services will include the review, preparation and submission of regulatory documents; education and training; expertise for study report review; compliance audits; and document tracking, maintenance, and archival.
"We look forward to applying our expertise in biomedical and regulatory affairs to a program that improves national and global health through clinical research and development of new drugs, biologics and devices to treat or prevent infectious diseases," said Robert McCord, SAIC senior vice president and business unit general manager.
SAIC is a scientific, engineering, and technology applications company.