Data Management Support for Vaccine Clinical Trials

The National Institutes of Health, National Institute of Allergy and Infectious Diseases (NIAID), Office of Acquisitions, Acquisitions Management and 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. to permit frequent reviews of interim safety and accrual data, and immunogenicity data during conduct of clinical studies; 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 and; 4. to manage and maintain a secure data warehouse which will serve as the repository for current and historical VRC laboratory, clinical, statistical, and other research data. The Contractor will be required to provide a data management system 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 an electronic format. ***Note: This is not a requirement for the development of a de novo, custom-built, enterprise software system. The Contractor must have existing experience with clinical trials data collection and management and possess a web-accessible software application which has demonstrated capability in data collection and management of vaccine clinical trials. In addition to the clinical trials data management system, the contractor must also be able to provide a secure archive of clinical trials data as a repository for current and historical laboratory, clinical, statistical, and other clinical trials data that may be needed to support regulatory reporting and ongoing user needs. The Contractor's system must meet current rules and regulations of Good Clinical Practice (GCP) as established by the FDA and Code of Federal Regulations (21CFR312); be capable of secure transfer and upload of coded clinical laboratory data; and provide for the ability for customizations necessary for study-specific programming within a limited time-frame. 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 Food and Drug Administration (FDA) and the other regulatory agencies that oversee human clinical trials; therefore, the Contractor's data management software systems must be secure, validated, and auditable for the collected data.  The Contractor will be required to provide qualified, professional data managers, programmers and statistical support personnel to provide data collection, security, maintenance, archiving, and report generation; create training and testing modules; and facilitate 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 Good Clinical Practice.  On or about October 15, 2008, the NIH/NIAID intends to award a cost type contract for a base performance period of one-year.  The solicitation/contract will also contain the provisions at FAR 52-217.8 for the consideration of four (4) additional option years of performance.  The solicitation will be available for download on or about May 30, 2008. No hardcopies will be distributed. Any questions concerning this requirement must be submitted in writing, by e-mail only, to LaDonna Stewart at lstewart@niaid.nih.gov.