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Statistical & Data Coordinating Center

Solicitation Number: NIH-NIAID-DAIT-08-10
Agency: Department of Health and Human Services
Office: National Institutes of Health
Location: National Institute of Allergy and Infectious Diseases
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NIH-NIAID-DAIT-08-10
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Award Notice
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June 16, 2008
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HHSN272200800029C
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$38,900,760
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Rho Federal Systems Division, Inc.
:
6330 Quadrangle Drive, Suite 500

Chapel Hill, North Carolina 27517
United States
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Added: Jun 16, 2008 4:06 pm
The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), of the Department of Health and Human Services (DHHS) supports research related to the basic understanding 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. The NIAID, Division of Allergy, Immunology, and Transplantation (DAIT) has a requirement for capabilities and facilities to establish and manage a Statistical and Data Coordinating Center (SDCC) to support NIAID sponsored clinical research programs in allergy/asthma, autoimmune, and transplant-related diseases.

Description

The Division of Allergy, Immunology, and Transplantation (DAIT) of the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (DHHS), intends to recompete a requirement for capabilities and facilities to establish and manage a Statistical and Data Coordinating Center (SDCC) to support NIAID sponsored clinical research programs in allergy/asthma, autoimmune, and transplant-related diseases.



The Immune Tolerance Network (ITN) was established in 1999 and is currently under a contract to the University of California, San Francisco. The overall goal of the ITN is to accelerate the evaluation of promising approaches for the induction and maintenance of immune tolerance in four clinical areas: solid organ transplantation, islet cell transplantation, autoimmune diseases, and asthma and allergic diseases.



The Contractor shall serve as the SDCC for clinical and non-clinical research activities carried out by the ITN with the responsibility for a broad range of support functions, including: statistical design and analysis; clinical data collection, storage, management, quality control, reporting and associated training for clinical site personnel; safety oversight; preparation of study-related materials; and clinical study website development and maintenance.



(Note: Although the ITN generates both clinical and mechanistic data from each trial, the scope of SDCC statistical functions is limited only to clinical data as specified in each protocol. Statistical design and analysis of mechanistic data and combined data from both clinical trials and mechanistic studies will be performed collaboratively by the ITN Clinical Trials Group and the ITN Bioinformatics Group).



The contract will be funded for a base period of six (6) years to provide SDCC support for the research activities of the ITN. In addition, the Government reserves the right to exercise two (2) options: Option 1 provides for an extension of the contract for one (1) additional year to continue the SDCC support services. Option 2 provides SDCC support for other DAIT-sponsored research programs and projects involving clinical research on immune-mediated diseases, including asthma and allergic diseases, solid organ, tissue and cell transplantation, and autoimmune disorders. These other programs and projects that may be supported under Option 2 include new individual clinical trial grants and existing and future clinical research programs/networks and projects awarded by DAIT.

:
Office of Acquisitions
6700 B Rockledge Room 3214 MSC7612
Bethesda, Maryland 20892-7612
:
Donald E Collie,
Contracting Officer
Phone: 301-496-0992
Fax: 301-480-4675