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FBO DAILY ISSUE OF NOVEMBER 22, 2003 FBO #0725
SOLICITATION NOTICE

A -- Clinical Site Monitoring Group - DAIT

Notice Date
11/20/2003
 
Notice Type
Solicitation Notice
 
Contracting Office
Department of Health and Human Services, National Institutes of Health, National Institutes of Allergy and Infectious Diseases, Contract Management Branch 6700 B Rockledge Room 2230 MSC7612, Bethesda, MD, 20892-7605
 
ZIP Code
20892-7605
 
Solicitation Number
RFP-NIH-NIAID-DAIT-04-46
 
Response Due
2/24/2004
 
Archive Date
2/25/2004
 
Point of Contact
Barbara Shadrick, Senior Contracting Officer, Phone 301-496-7288, Fax 301-480-5253,
 
E-Mail Address
bs92y@nih.gov
 
Description
The Division of Allergy, Immunology and Transplantation (DAIT), of the National Institute of Allergy and Infectious Diseases (NIAID), of the National Institutes of Health (NIH), intends to compete a requirement currently being performed under a subcontract to The EMMES Corporation (N01-AI-95382). This solicitation is being issued as a full and open competition. The applicable NAICS Code is 541710. DAIT plans, sponsors and directs national and international extramural research programs in basic immunology, asthma and allergic and immunologic diseases. Through these programs, DAIT-supported investigators conduct basic, pre-clinical and clinical investigations into the causes, diagnosis, prevention and treatment of a broad range of immune-mediated disorders. DAIT intends to solicit proposals from organizations capable of performing clinical site monitoring services in support of DAIT?s Immune Tolerance Network (ITN). Under this contract, the contractor will establish a Clinical Site Monitoring Group (CSMG) to assess the quality and enhance performance of sites participating in the Immune Tolerance Network (ITN). In FY 1999, the NIAID established the Immune Tolerance Network (see http://www.immunetolerance.org) an international consortium of over 70 basic scientists and clinical investigators, to test promising tolerogenic treatment regimens in four clinical areas: islet transplantation; kidney transplantation; autoimmune diseases; and asthma and allergic diseases. In FY 2000, the ITN began accepting proposals for clinical trials of tolerance induction and has completed 14 full review cycles by July 2002. A total of 155 concept proposals have been submitted and 46 were accepted for submission as full proposals; non-ITN members submitted approximately 75% of these. To date, 21 clinical trials have been approved for implementation in all four clinical areas. This contract will be managed by the DAIT Office of Clinical Applications, who is responsible for site monitoring and regulatory activities associated with clinical trials in organ and islet transplantation, autoimmune diseases, and asthma and allergic diseases. Work to be performed will include: monitoring of clinical research studies conducted by the ITN; initiating and monitoring of sites and pharmacies conducting DAIT-supported ITN studies in the United States and abroad; and monitoring of laboratory facilities and procedures for obtaining testing and storing clinical research specimens, when requested as a special assignment; training site personnel on good clinical practice and on the policies and procedures established by DAIT, the Food and Drug Administration (FDA), the Office of Human Research Protections (OHRP) and the ITN; recruiting and training site monitors; providing reports on monitoring findings and training activities; collaborating with DAIT and the ITN; and facilitating an orderly transition to a subsequent contractor. Offeror?s proposals should demonstrate related ability and experience for monitoring clinical sites and their pharmacies and laboratories; training site staff in policy, procedures and good clinical practices; monitoring domestic and international clinical sites; ability to recruit a full monitoring staff within four months of contract award with minimum Bachelor?s Degree or equivalent in nursing, pharmacy, biology or other biomedical sciences; sufficient number of monitors possessing special international site monitoring qualifications; adequacy and availability of professional staff other than monitors; and documented evidence of successful organizational experience in providing monitoring services for multi-site clinical trials. It is anticipated that a single cost reimbursement, completion type contract will be awarded for a 7-year period of performance beginning on or about September 30, 2004, and require an estimated 9 to 10 FTEs with expertise consistent with the operations of a project of this size and complexity. RFP-NIH-NIAID-DAIT-04-46 will be available electronically on or about December 3, 2003, may be accessed through the NIAID Contract Management Program (CMP) Home Page at http://www.niaid.nih.gov/contract and will be posted on FedBizOpps. Any responsible offeror may submit a proposal that will be considered by the Government. This notice does not commit the Government to award of a contract. No collect calls will be accepted. No facsimile transmissions will be accepted. See Government-Wide Numbered Note 26.
 
Record
SN00473427-W 20031122/031120211957 (fbodaily.com)
 
Source
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)

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