A -- Clinical and Statistical Coordinating Center for Cooperative Clinical Trials

The Division of Allergy, Immunology and Transplantation (DAIT), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (DHHS), intends to negotiate with The EMMES Corporation for a modification of its contract No. N01-AI-15423, that was awarded as a 100% small business set-aside, under SIC 8731; NAICS 541710; size standard of 500 employees. This contract supports NIAID's research program to develop and evaluate novel therapeutic regimens for prolonging graft and patient survival, while minimizing unwanted side effects of immunosuppression, in pediatric renal transplantation. Clinical trials are supported by separate Cooperative Agreement awards and are developed by the Cooperative Clinical Trial in Pediatric Transplantation (CCTPT) Steering Committee in collaboration with NIAID. The contractor provides statistical, clinical, technical, regulatory, and administrative expertise to NIAID, its investigators, and an independent data and safety monitoring board (DSMB). The planned negotiated modification will permit increased effort for the remaining period of performance in order to expand the scope of work: (1) provide statistical and clinical trial design expertise for new clinical trials in pediatric and adult renal transplantation, including the development of mechanistic studies on the immunomodulatory approaches conducted by the CCTPT; (2) establish and administer systems for the collection, storage, management, quality assurance, and reporting of study data; (3) conduct clinical trial site monitoring and training for all clinical trial sites; (4) provide support for regulatory functions associated with Investigational New Drug (IND) applications, including the preparation of interim and annual reports required by regulatory agencies; (5) establish and manage a system for the distribution and quality control of study products and supplies, and; (6) provide statistical, administrative, technical, and logistical support for the CCTPT steering committee and the independent DSMB. This will be for immediate use by CCTPT investigators and DSMB members. These activities will require expansion of all aspects of the contractor's infrastructure, already in place, to meet the increased needs of the NIAID-supported clinical trials. Authority: 41 USC 253(c)(1), as set for in FAR 6.302-1(a)(2)(ii). If there are responsible sources who feel that they are able to perform this expansion, they must respond by submitting three (3) copies of the information required by Numbered Note 22 on/before the closing date noted in this announcement. Organizations that submit capability statements in response to this announcement must demonstrate their ability to assume the work without unnecessary delay and duplication of cost and effort. You are directed to Government-Wide Numbered Notes 22 and 26. No collect calls will be accepted.