Clinical Research Support and Collaboration for NHGRI Protocols

The contractor shall provide services under four task areas: (1) Protocol Monitoring and Data Management Support Services, including managing the NHGRI Clinical Director's intramural monitoring and quality assurance program, conducting on-site source document verification, managing clinical trials assurance schedules, and providing data management support; (2) Regulatory Support for IND and IDE Submissions, including preparing and submitting new and existing IND applications and associated amendments, reports, and transfers in eCTD format, and conducting IND gap analyses; (3) Data Safety and Monitoring Board (DSMB) Support, including arranging DSMB meetings, recording minutes, and serving as Executive Secretary; and (4) Statistical Expertise, including providing senior-level statisticians for study design consultation, power analyses, and statistical analysis. Work is primarily performed at the contractor's site with some travel to NHGRI in Bethesda, MD. The contract is an IDIQ with a three-year ordering period (January 1, 2027 – December 31, 2029) and a single award. Task orders will be time and materials or firm fixed-price. The Government currently anticipates issuing Task Order 1 for Proteus Syndrome Support (January 1, 2027 – December 31, 2027).