SOLICITATION NOTICE
R -- VRC Data Management Support of Vaccine Clinical Trials
- Notice Date
- 7/13/2007
- Notice Type
- Solicitation Notice
- 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
- NIHAO2007002
- Response Due
- 8/27/2007
- Archive Date
- 9/30/2007
- Description
- The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), of the Department of Health and Human Services (DHHS) has a sole source requirement for programming personnel and resources to manage the Vaccine Research Center's (VRC) long-term comprehensive data management plan for its Clinical Trials Core. The goals of the data management plan are: 1. to enable the VRC to rapidly and efficiently analyze the results of vaccine clinical trials following study completion; 2. permit frequent reviews of interim safety and accrual data during conduct of a clinical trial; and 3. to 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. On, or about 10/1/2007, the NIAID Acquisitions Management Operations Branch (AMOB) intends to award a sole source contract, in accordance with FAR 6.302-1, for data management support to the EMMES Corporation of Rockville, MD. This contract award will be for a one-year period of performance, and will also contain the provision at FAR 52-217.8 for the consideration of four additional option years of performance. The EMMES Corporation using its proprietary data collection software has performed as the sole compiler of and processor of all VRC Clinical Trials repository data. This data includes patient enrollment, clinical evaluations, treatment records, adverse events data, subject status, 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. Current Phase I/II domestic and international clinical trials that have been initiated using the EMMES data collection platforms must be completed using the same protocols to preserve the integrity of data and the trials' utility for ultimate licensure of prospective candidate vaccines. It is not possible to transfer these trials' data management functions to another contractor without re-starting the clinical trials from their inception - a step that would severely harm the Government's investment in time, resources, and funds in the development processes to achieve an effective vaccine treatment for a number of emerging infectious diseases including HIV/AIDs. To the extent possible, EMMES will continue to use validated software and existing data management platforms established for the VRC Clinical Trials Core to facilitate the VRCs on-going programmatic needs - making minimal system customizations as necessary to meet current rules and regulations of Good Clinical Practice as established by the FDA and Code of Federal Regulations (21CFR312). Please refer any questions in writing to LaDonna Stewart at lstewart@niaid.nih.gov by 2:00 pm EDT, August 27, 2007. See numbered note 22.
- Place of Performance
- Address: Bethesda/Rockville, MD
- Zip Code: 20892
- Country: UNITED STATES
- Zip Code: 20892
- Record
- SN01341732-W 20070715/070713220655 (fbodaily.com)
- Source
-
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