Best Pharmaceuticals for Children Act DCC

The National Institute of Child Health and Human Development intends to solicit a single Indefinite-Delivery, Indefinite-Quantity cost-reimbursement contract for a Data Coordinating Center to provide clinical data management, statistical analysis, regulatory support, and data quality oversight for pediatric clinical trials under the Best Pharmaceuticals for Children Act, with RFP release anticipated on or about August 14, 2026, and proposals due on or about September 28, 2026.

The contract carries a ten-year ordering period under NAICS 541715. The DCC will manage data from approximately 40 closed studies, 10 ongoing clinical trials, and up to 20 new trials. Responsibilities include establishing data capture and quality oversight systems, leading FDA regulatory activities (IND and NDA submissions), managing the Data Safety Monitoring Board, conducting clinical site monitoring and training for approximately 50 sites annually, providing statistical analysis leadership, coordinating consortium activities among multiple contractors, and developing de-identified public-use datasets. The scope encompasses domestic and international clinical sites.

Offerors must demonstrate expertise in pediatric clinical trial data coordination, biostatistics, regulatory affairs, clinical trial monitoring, information technology, and administrative functions. Technical qualifications include experience managing multiple clinical sites, performing pediatric drug development regulatory requirements, working within contractor consortiums, developing public-use datasets, establishing secure data systems compliant with NIH and FISMA requirements, managing pharmacy and specimen tracking programs, and establishing Data Safety Monitoring Board operations.

All solicitation materials will be available through SAM.gov. Offerors must be registered in the System for Award Management prior to award. Questions: Theresa Ranjit (Primary) at Theresa.Ranjit@nih.gov or Noor Shakeel (Secondary) at Noor.Shakeel@nih.gov.