SOURCES SOUGHT
A -- Phase I Clinical Trial Unit for Therapeutics Against Infectious Diseases
- Notice Date
- 12/13/2006
- Notice Type
- Sources Sought
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Office of Acquisitions 6700 B Rockledge Room 3214 MSC7612, Bethesda, MD, 20892-7612, UNITED STATES
- ZIP Code
- 00000
- Solicitation Number
- RFP-NIH-NIAID-DMID-08-06
- Response Due
- 12/28/2006
- Archive Date
- 1/12/2007
- Description
- THIS NOTICE IS FOR INFORMATION AND PLANNING PURPOSES ONLY. THIS IS NOT A REQUEST FOR PROPOSALS AND DOES NOT COMMIT THE GOVERNMENT TO AWARD A CONTRACT NOW OR IN THE FUTURE. NO SOLICITATION IS AVAILABLE AT THIS TIME. BASED ON CAPABILITY STATEMENTS RECEIVED FROM THIS SOURCES SOUGHT NOTICE, THIS ACQUISITION MAY BE SOLICITED AS A 100% SMALL BUSINESS SET-ASIDE OR AS FULL AND OPEN. ALL SMALL BUSINESS ORGANIZATIONS (SB, SDB, WOSB, HUBZone, VOSB, and SDVOSB) ARE ENCOURAGED TO RESPOND TO THIS NOTICE. SMALL BUSINESS ORGANIZATIONS MUST HAVE THEIR SIZE STATUS CERTIFIED BY THE SMALL BUSINESS ADMINISTRATION. THE NAICS CODE IS 541710 WITH A SIZE STANDARD OF 500 EMPLOYEES. Research supported and conducted by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (DHHS), strives to understand, treat and ultimately prevent the myriad infectious, immunologic, and allergic diseases that threaten millions of human lives. The NIAID Division of Microbiology and Infectious Diseases (DMID) supports extramural research to control and prevent diseases caused by virtually all infectious agents other than HIV. This includes basic and applied research to develop and evaluate therapeutics, vaccines, and diagnostics that is funded through a variety of research grants and contracts. The Division also supports substantial preclinical research efforts to develop new therapeutics. It is anticipated that these efforts will produce many promising investigational products that will require initial testing in humans in Phase I clinical trials. In order to ensure the capacity to evaluate the growing pipeline of investigational products as they become available, it is critical for DMID to establish the dedicated resources necessary to undertake Phase 1 clinical trials for a broad range of infectious diseases. The NIAID is seeking capability statements from sources that are capable of the providing and managing of a Phase I Clinical Trial Unit for Therapeutics Against Infectious Diseases to fill this need. This phase I unit will operate under Good Clinical Practices (GCP) and will provide and support electronic data capture system. NIAID anticipates that minimum of four (4) protocols will be implemented in each year of the contract. Each protocol will include pK/pD and safety evaluation of investigational therapies. It is estimated that 150 healthy adults (18 ? 45 of age) will be recruited each year, and at least 45% of those will be from minority groups. The clinical protocols and all additional clinical documents needed (such as CRFs, MOP, etc) will be developed by the potential source. The potential source will also provide independent monitoring abilities, electronic data capturing ability and data management capacity. Potential sources must demonstrate and document the following in their capability statements: 1. relevant experience in conducting pK/pD and safety first in human trials of novel therapeutics under Good Clinical Practices (GCP); 2. ability to recruit the needed patient populations; 3. ability to provide independent monitoring; 4. ability to provide and maintain electronic data capturing system; 5. capacity and facilities to perform inpatient trials; 6. relevant experience in development clinical protocols and associated clinical documents; 7. relevant experience and expertise of personnel and adequacy of relevant training. Interested organizations should submit two (2) copies of their capability statement addressing each of the areas cited above. Interested organizations presenting a capability statement in response to this sources sought announcement must identify their size status. Written capability statements should be received by the NIAID Contracting Officer by December 28, 2006. Please reference the solicitation number on all related correspondence. No collect calls will be accepted. Facsimile and e-mail transmissions will be accepted. Any proprietary information should be so marked. See Government-wide numbered note 25.
- Record
- SN01195618-W 20061215/061213220332 (fbodaily.com)
- Source
-
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