SOURCES SOUGHT
A -- Clinical Trial Management Support
- Notice Date
- 9/27/2002
- Notice Type
- Sources Sought
- 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
- Reference-Number-SS-NIH-NIAID-DMID-03-33
- Point of Contact
- Joshua LaVine, Contract Specialist, Phone 301496-2509, Fax 301-402-0972, - Jacqueline Holden, Senior Contracting Officer, Phone 301-496-7119, Fax 301-402-0972,
- E-Mail Address
-
jl276z@nih.gov, jh55b@nih.gov
- Description
- The Division of Microbiology and Infectious Diseases (DMID), of the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), is seeking capability statements from organizations with clinical and technical expertise and facilities to provide clinical trial management support to DMID?s clinical research program. The Contractor will assist DMID in the management of its clinical research program by providing the following clinical trial support: (a) Clinical site assessment; (b) Clinical site preparation and clinical trail operational assistance, including the establishment of appropriate internal Quality Control/Quality Assurance (QC/QA) procedures and systems; (c) External Quality Assurance monitoring; (d) Pharmacovigilance/Safety Monitoring; General logistical support and administrative coordination for DMID?s clinical research program; and (f) Implementation and maintenance of information management systems. In order to maintain unbiased and objective evaluations of clinical trial conduct, the external QA program and staff responsible for monitoring a clinical site must be independent and separate from the clinical trial site?s internal QC/QA program and staff. This is a new effort; there is no incumbent. Offerors will be evaluated on: technical approach; ability to provide clinical site preparation support services and clinical trial operational assistance to DMID clinical trial sites involved in the conduct of Phase I-IV trials in domestic and international settings; providing general and protocol-specific clinical research management of a global portfolio of DMID Phase I-IV clinical trials in domestic and international settings; staff and expertise; organizational experience, facilities and resources. It is anticipated that the period of performance for this contract will be a total of five years with an estimated level-of-effort of 110,240 labor hours per year. Interested Small Business organizations should submit two (2) copies of their capability statement addressing each of the areas cited above. See Numbered Note 22. No collect calls will be accepted. No facsimile transmissions will be accepted. 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, THIS ACQUISITION MAY BE SOLICITED AS A 100% SMALL BUSINESS SET-ASIDE, NAICS CODE 541710, WITH A SIZE STANDARD OF 500 EMPLOYEES.
- Record
- SN00177484-W 20020929/020927213325 (fbodaily.com)
- Source
-
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