NIAID CLINICAL DATA AND SAFETY MANAGEMENT CENTER (CDSMC)

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Through the contract award, the Division of Allergy, Immunology, and Transplantation intends to provide a Clinical Data and Safety Management Center (CDSMC) to support a wide range of clinical research data management, safety and pharmacovigilance management for NIAID-funded clinical trials and clinical studies of immune-mediated diseases. The Contractor will establish a CDSMC that will provide Data Management and Reporting, Clinical Safety and Pharmacovigilance, and a Specimen Tracking processes for NIAID supported clinical trials and studies (including mechanistic) for both domestic and/or international research. Primary scientific areas of support include allergic diseases and asthma; autoimmune disorders; immune-mediated rejection in solid organ, tissue and cell transplantation; primary immune deficiency disorders; and other immune system disorders and treatments to enhance immune functions but may expand to other NIAID sponsored areas