This Government Contract opportunity was posted on December 16, 2011. The submission period has ended. Browse the details below for market research, or find similar active opportunities.
NIAID Division of Allergy, Immunology and Transplantation: Clinical Site Monitoring Center
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The NIAID Division of Allergy, Immunology and Transplantation is establishing a Clinical Site Monitoring Center to provide comprehensive monitoring services for clinical research studies. The primary objective is to ensure strict compliance with regulatory standards, including Title 21 CFR Part 312, Title 45 CFR Part 46 regarding Human Subjects Protection, and ICH/GCP guidelines. These services support the Immune Tolerance Network and other DAIT-funded programs, including investigator-initiated studies conducted under grants. The scope of work covers Phase I through IV trials, as well as epidemiological, mechanistic, and natural history or observational studies. The contract encompasses a wide range of immune-mediated diseases, such as autoimmune disorders, asthma, allergic diseases, and organ transplantation rejection. Monitoring will be conducted across single- and multicenter sites located within the United States and internationally, specifically in Australia, the United Kingdom, Western Europe, and the Americas.
General Info
Agency
Contract Value
$27,036,076.33Place of Performance
NC, USASet-Aside
Awardee
PPD DEVELOPMENT LPAward Issued Date
Documents
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Timeline
Submission Closed
Organization & Contact Information
Full Description
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