SOLICITATION NOTICE
R -- VRC DATA MANAGEMENT SUPPORT FOR VACCINE CLINICAL TRIALS
- Notice Date
- 11/21/2013
- Notice Type
- Presolicitation
- 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, Maryland, 20817
- ZIP Code
- 20817
- Solicitation Number
- NIHAO2014001
- Archive Date
- 5/5/2014
- Point of Contact
- Sharee Richardson, Phone: 3014026615
- E-Mail Address
-
sharee.richardson@nih.gov
(sharee.richardson@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- The National Institute of Allergy and Infectious Diseases (NIAID), Acquisitions Management Operations Branch (AMOB) has a requirement for a contractor to provide data management support to the Vaccine Research Center (VRC). The goals of this solicitation are: 1. To 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. To create, manage, and maintain a secure data repository for current and historical VRC laboratory, clinical, statistical, and other research data. The Contractor will be required to provide a Clinical Data Management System (CDMS) utilizing an internet-based, windows compatible platform for data entry that can be accessed from multiple sites (domestic and international) which will allow protocol and study participant data to be collected directly in electronic form. **Note: This is not a request for the development of a de novo, custom-built, enterprise software system. The Contractor must have prior experience with implementation of an existing CDMS that is web-accessible for direct data entry at clinical trial sites. Demonstrated experience with successful deployment for data management of vaccine clinical trials is a preferred characteristic. The data management system must be capable of secure transfer and upload of coded clinical laboratory data, as well as the ability to be customized for study-specific programming in a limited time-frame, and meet current rules and regulations of Good Clinical Practice (GCP) as established by the Food and Drug Administration (FDA) and Code of Federal Regulations (21CFR312). Data collection requirements will include, but are not limited to, 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 FDA and the other regulatory agencies that oversee human clinical trials; therefore, the Contractors data management systems must be validated, auditable, and utilize secure socket layer (or an alternate mechanism) protection for the collected data and system information. 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; creating training and testing modules; and other related data management services throughout the conduct of each specified clinical trial to ensure that all data and reports meet regulatory standards and are consistent with current GCP. On or about April 14, 2014 the NIH/NIAID intends to award a cost type contract with a base performance period of one-year. The solicitation/contract will also contain the provisions at FAR 52.217-9 for the consideration of four (4) additional option years of performance. The solicitation will be available for download on or about December 16, 2013. No hardcopies will be distributed. Any questions concerning this requirement must be submitted in writing, by email only, to Sharee Richardson at sharee.richardson@nih.gov.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/AMOB/NIHAO2014001/listing.html)
- Place of Performance
- Address: All performance related to this requirement will be conducted at the Contractor's facilities, United States
- Record
- SN03238622-W 20131123/131121234005-59824f05e1544fb8c6edad49871860cb (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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