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This Government Contract opportunity was posted on June 16, 2008. The submission period has ended. Browse the details below for market research, or find similar active opportunities.

Statistical & Data Coordinating Center

Awarded
NIH-NIAID-DAIT-08-10Federal

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The National Institute of Allergy and Infectious Diseases, through the Division of Allergy, Immunology, and Transplantation, is seeking a contractor to establish and manage a Statistical and Data Coordinating Center to support the Immune Tolerance Network. The primary objective is to accelerate the evaluation of methods for inducing and maintaining immune tolerance across four key clinical areas: solid organ transplantation, islet cell transplantation, autoimmune diseases, and asthma and allergic diseases. The contractor will be responsible for a wide array of support functions, including statistical design and analysis of clinical data, data collection and storage, quality control, safety oversight, and the development of study-related materials and websites. The contract is structured with a base period of six years, with the government retaining the option to extend the term by one additional year. Furthermore, a second option allows the center to provide support for other research programs and projects sponsored by the Division of Allergy, Immunology, and Transplantation involving immune-mediated diseases. While the center handles clinical data, the analysis of mechanistic and combined data remains a collaborative effort between the Immune Tolerance Network Clinical Trials Group and the Bioinformatics Group.

General Info

Agency

N/A

Contract Value

$46,292,142.39

NAICS

541711 - Research and Development in Biotechnology

Place of Performance

NC, USA

Set-Aside

NONE

Award Issued Date

Documents

0

No documents available

Documents will appear here when they are available.

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Timeline

PhaseAwarded
Posted

Award Notice

Awarded

Contract was awarded

Submission Closed

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Organization & Contact Information

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AgencyN/A
Contacts1 person available
OfficeN/A
Organization / Agency
N/A
Office AddressN/A
Contacts
Donald E CollieContracting Officer

Full Description

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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.

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