Data Coordinating Center (DCC) for the Best Pharmaceuticals for Children Act (B

The National Institute of Child Health and Human Development (NICHD) is seeking a Data Coordinating Center (DCC) to support the Best Pharmaceuticals for Children Act (BPCA) program. The contractor will be responsible for comprehensive data management, analysis, and regulatory reporting for pediatric clinical trials, including managing approximately 30 ongoing trials and 10 new trials annually across 15 clinical sites. Key contract requirements include developing transition plans for archived trials, establishing electronic data collection systems compliant with federal policies, managing FDA regulatory submissions, implementing data safety monitoring, and providing quality assurance for over 120 clinical sites with more than 1,000 participant enrollments per year. Responses to the sources sought notice are due by January 28, 2025, and must be limited to 15 pages excluding resumes. The solicitation targets small businesses with demonstrated capabilities in information technology, regulatory compliance, clinical trial management, and statistical expertise.

The procurement falls under NAICS category 541715 with a small business size standard of 1,000 employees or less, and is open to various small business designations including 8(a), HUBZone, service-disabled veteran-owned, woman-owned, and small disadvantaged businesses. While specific award values are not detailed in the pre-solicitation notice, the contract will involve managing a complex clinical research coordination effort with significant data management and regulatory reporting responsibilities. The project scope encompasses supporting approximately 40 clinical trials annually, with extensive statistical analysis and regulatory compliance requirements. The contract will likely involve multiple years of service, supporting critical pediatric pharmaceutical research across various clinical sites. Interested contractors must demonstrate robust capabilities in managing complex, multi-site clinical research data and navigating intricate regulatory environments specific to pediatric pharmaceutical research.