A -- Islet/Beta Cell Transplant Registry

The contract with The EMMES Corporation, under Contract No. N01-DK-1-2472, is being expanded to enhance support for the National Institute of Diabetes and Digestive and Kidney Diseases' (NIDDK) efforts related to islet transplantation. The scope includes coordinating and delivering statistical, technical, logistical, and administrative services for the NIDDK Islet Transplantation Data and Safety Monitoring Board (DSMB). Additionally, the contract encompasses managing all administrative and coordination tasks tied to the NIDDK’s clinical investigation of islet transplantation in Medicare beneficiaries, as required by the Medicare Reform Bill of 2003. A further element of the contract involves developing a database conversion program for Centers that are part of the Collaborative Islet Transplant Registry (CITR). This contract extension is authorized under federal procurement regulations specified in 41 U.S.C. 253 (c)(1), reflecting a justification for non-competitive procedures. The overall objective supports NIDDK’s mandate to oversee and advance clinical research and safety monitoring in islet transplantation, facilitating regulated Medicare involvement and improving data management across contributing transplant centers. This ensures ongoing compliance and coordinated progress in this specialized area of medical research and patient care.