Data Coordinating Center for BPCA

The National Institute of Child Health and Human Development (NICHD), part of the Department of Health and Human Services National Institutes of Health, is seeking a Data Coordinating Center (DCC) to provide clinical data management, statistical analysis, regulatory support, and data quality oversight for pediatric clinical trials conducted under the Best Pharmaceuticals for Children Act (BPCA) program. The primary objective is to support FDA regulatory submissions and advance pediatric drug development research. Qualified offerors must demonstrate extensive experience managing concurrent pediatric trials domestically and internationally, providing regulatory support for Phase 2 and Phase 3 drug development studies, and maintaining IT systems compliant with NIH FISMA security requirements. Capability statements will be evaluated based on demonstrated experience with pediatric trial management, regulatory expertise for IND/NDA submissions, statistical leadership capabilities, and ability to establish Data Safety Monitoring Boards while ensuring compliance with good clinical practices. The response deadline has been extended to April 6, 2026 at 4:00 PM EDT, with capability statements submitted to Theresa.Ranjit@nih.gov and Noor.Shakeel@nih.gov, limited to 15 pages single-spaced in 11-point font or greater.

This is a Sources Sought announcement for market research purposes with no set-aside designation, though the government is specifically seeking information about small business availability and capability, including those with HUBZone, service-disabled veteran, 8(a), veteran, woman-owned, or disadvantaged business status. No contract will be awarded from this notice; responses are intended to inform the government's acquisition strategy and potential for a future small business set-aside. The DCC will be responsible for supporting approximately 15 concurrent pediatric clinical trials with up to 3 additional new trials annually, each involving approximately 20 clinical study sites. Qualified small businesses must have 1,000 employees or fewer and fall under NAICS code 541715 (Research and Development in the Physical, Engineering, and Life Sciences). No specific budget range or award value is disclosed in this pre-solicitation notice, as this announcement is designed to assess market capability rather than to solicit formal proposals or establish contract terms.