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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

Awarded
RFP-NIAID-DAIT-NIHAI2010032Federal

Contract Overview

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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

N/A

Contract Value

$27,036,076.33

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

2 updates
PhaseAwarded
Posted

Presolicitation

Notice updated

The notice description changed.

Notice updated

Notice details unchanged. Attachments may have changed.

Type Changed

Presolicitation → Solicitation

Awarded

Contract was awarded

Submission Closed

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Organization & Contact Information

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AgencyN/A
Contacts2 people available
OfficeN/A
Organization / Agency
N/A
Office AddressN/A
Contacts
MyLinh PhamContract Specialist
David T. LisleContracting Officer

Full Description

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This initiative will provide DAIT with comprehensive clinical site monitoring services to fulfill its responsibilities as the funder and/or sponsor of clinical research studies conducted by the immune tolerance network(ITN) by ensuring compliance with applicable regulations, including Title 21 Code of Federal Regulations (CFR) Part 312, Human Subjects Protection Title 45 CFR Part 46, and E6 International Conference on Harmonization good Clinical Practices (ICH/GCP). In addition, Clinical Site monitoring services will include DAIT-supported, investigator-initiated clinical research studies conducted under grants, as well as other DAIT-funded clinical research programs on a limited, as-needed basis. These services will be provided for single-and multicenter sites in the U.S. and international sites, including sites in the Americas, the United Kingdom, Western Europe, and Australia. Types of studies: Phase I - IV; epidemiological; mechanistic; natural history/observational. Diseases under evaluation: immune mediated, diverse and complex (asthma and allergic diseases; autoimmune disorders; and immune-mediated rejection in solid organ, tissue and cell transplantation).

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