R -- Data Management Support for Clinical Trials

The National Institute of Allergy and Infectious Diseases (NIAID), Acquisitions Management and Operations Branch (AMOB) intends to award a sole source contract for data management support to The EMMES Corporation of Rockville, MD. NIAID intends to award a one year contract with the option for two additional years beginning on or before September 30, 2004. The resulting contract will also contain the provision at FAR 52.217-8. The contractor will be responsible for providing data management support for the VRC Clinical Trials Core. EMMES has performed as the sole compiler and processor of all comprehensive clinical data collected for all currently ongoing Phase I clinical trials carried out by the VRC Clinical Trials Core. This data management function is essential to ensure that the results of clinical trials of novel vaccine strategies can be rapidly and efficiently analyzed at study completion, and to permit frequent review of interim safety and accrual data during conduct of a clinical trial. This comprehensive data management is essential for accomplishment of VRC clinical research goals and 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. The current Phase I clinical trials have been initiated using EMMES Internet Data Entry System (IDES), and must be completed using the same protocols to preserve these trials' utility for ultimate licensure of candidate vaccines. It is not possible to transfer these trial data management functions to another contractor without restarting clinical trials from their inception, a step that would impose a loss of several years time in the development process to achieving an effective HIV/AIDS vaccine. Please refer any questions in writing to Terrie Nestor at contact@example.gov by August 27, 2004 at 2:00 pm EDT. See numbered note 22.