SOURCES SOUGHT
R -- VRC Data Management Support for Vaccine Clinical Trials
- Notice Date
- 12/6/2007
- Notice Type
- Sources Sought
- NAICS
- 541511
— Custom Computer Programming Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Allergy & Infectious Diseases/AMOB, 10401 Fernwood Drive, Suite 2NE70, MSC 4811, Bethesda, MD, 20817, UNITED STATES
- ZIP Code
- 00000
- Solicitation Number
- NIHAO2008009
- Response Due
- 12/20/2007
- Point of Contact
- LaDonna Stewart, Contracting Specialist, Phone 301-451-8117, Fax 301-480-0689, - Terrie Nestor, Contracting Officer, Phone 301-402-6790, Fax 301-480-0689
- E-Mail Address
-
lstewart@niaid.nih.gov, tnestor@niaid.nih.gov
- Description
- The National Institute of Allergy and Infectious Diseases (NIAID), Acquisitions Management Operations Branch (AMOB) is currently seeking small business sources that can provide data management support to the Vaccine Research Center (VRC). The Contractor will be required to provide a data management system utilizing a web-based platform for data entry that can be accessed from multiple sites (domestic and international) to allow protocol and study participant data to be collected directly in electronic form. The goals of this solicitation are to: 1. enable the VRC to rapidly and efficiently analyze selected basic research and clinical study results; 2. permit frequent reviews of interim safety and accrual data, and immunogenicity data during conduct of clinical studies; 3. meet Code of Federal Regulations (21CFR312) requirements, for the proper conduct of the general investigational plan and protocols contained in the Investigational New Drug applications for new vaccine products; and 4. create, manage, and maintain a secure data warehouse to serve as the repository for current and historical VRC laboratory, clinical, statistical, and other research data. Data collection requirements will include patient enrollment, clinical evaluations, treatment records, adverse events data, subject status, immune response results, and other study-specific clinical evaluations as required for reporting to the Food and Drug Administration (FDA) and the other regulatory agencies that oversee human clinical trials. Therefore, the Contractor must use, or be able to provide, a validated and auditable software system using secure socket layer, or an alternate mechanism, for protection of clinical data and system information. The Contractor's software and data management platforms should also require minimal system customizations as necessary to meet current rules and regulations of Good Clinical Practice (GCP) as established by the FDA and Code of Federal Regulations (21CFR312). To the extent possible, the Contractor will use existing data management platforms and develop resources, as needed, for custom programming for the VRC to provide study-specific programming of the web-accessible data entry system in a limited time-frame. The Contractor will also be required to provide qualified, professional data managers, programmers and statistical support personnel to provide data security, maintenance, archiving, report generation and related data management services throughout the conduct of each clinical trial to ensure that clinical data and reports meet regulatory standards and are consistent with current GCP. The NIAID intends to award a cost-reimbursement contract for a one-year period of performance on or about 04/01/08. The contract will also contain the provisions at FAR 52-217.8 for the consideration of two additional option years of performance. This announcement is specifically for small businesses. No large businesses should respond to this announcement. Interested small businesses including Hub-zone, veteran-owned small business, service-disabled veteran-owned small business, small disadvantaged business, and women-owned small business concerns should respond with a capability statement in writing by mail to LaDonna Stewart, or by e-mail at lstewart@niaid.nih.gov by 11:00am EDT, December 20, 2007 (Teaming arrangements are encouraged). Capability statements must specify the offeror's business size and type, and demonstrate similar work that has been performed in the past and the dollar value of that work. Capability statements should also clearly demonstrate the offeror's ability to fully meet the technical and personnel requirements specified above. This is not a request for proposals. The intention of this announcement is to survey the market for potential offerors. Questions regarding this requirement must be submitted in writing and directed to LaDonna Stewart at lstewart@niaid.nih.gov before the closing date of this announcement.
- Place of Performance
- Address: Contractor's location
- Zip Code: 00000-0000
- Country: UNITED STATES
- Zip Code: 00000-0000
- Record
- SN01464935-W 20071208/071206223607 (fbodaily.com)
- Source
-
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