A--Data Coordinating Center for BPCA
Overview
Buyer
Place of Performance
NAICS
PSC
Set Aside
Original Source
Timeline
Qualification Details
Fit reasons
- NAICS alignment with historical contract wins in similar service areas.
- Scope strongly matches core technical capabilities and delivery model.
Risks
- Past performance thresholds may require one additional teaming partner.
- Potential clarification needed on staffing minimums before bid/no-bid.
Next steps
Validate eligibility requirements, assign capture owner, and schedule partner outreach to confirm teaming strategy before submission planning.
Quick Summary
The National Institutes of Health (NIH), specifically the National Institute of Child Health and Human Development (NICHD), is conducting market research through a Sources Sought notice for a Data Coordinating Center (DCC) to support the Best Pharmaceuticals for Children Act (BPCA) Clinical Program. This is not a solicitation but aims to identify qualified small business sources capable of providing clinical data management, statistical analysis, and regulatory support for pediatric clinical trials. Responses are due by March 31, 2026, at 4:00 PM EDT.
Scope of Work
The government is seeking capabilities related to operating a BPCA DCC, including:
- Providing personnel, facilities, and services for regulatory-rigorous clinical data management, statistical analysis, and FDA regulatory expertise.
- Supporting approximately 15 concurrent pediatric clinical trials and up to 3 new trials annually, potentially involving domestic and international sites.
- Ensuring state-of-the-art data capture, innovative data collection, data integrity, and quality assurance.
- Supporting regulatory activities for FDA-regulated clinical research, including IND/NDA submissions and coordinating regulatory documentation.
- Developing de-identified public use datasets.
- Establishing and managing electronic data collection, analysis, and storage systems compliant with federal requirements.
- Providing regulatory support for IND and NDA activities, and Clinical Study Report revisions.
- Developing and maintaining Data Safety Monitoring Plans and supporting Data Safety Monitoring Boards.
- Providing data quality assurance auditing and supporting monitoring/training compliance for high-risk clinical trials.
- Offering statistical leadership for analyses and FDA submissions.
- Supporting the BPCA Consortium Steering and Executive Committees.
- Providing expertise in protocol development for pediatric clinical trials.
- Demonstrating Information Technology and Security capabilities for data collection, management, quality assurance, reporting, and electronic communication.
Contract & Timeline
- Type: Sources Sought / Request for Information (AN12 - Health R&D Services; Health Care Services; Applied Research)
- Duration: Not applicable, as this is market research.
- Response Due: March 31, 2026, 4:00 PM EDT
- Published: March 16, 2026
Eligibility / Set-Aside
This notice is specifically seeking information from small businesses under NAICS code 541715 (Research and Development in the Physical, Engineering, and Life Sciences, except Nanotechnology and Biotechnology), with a size standard of 1,000 employees or less. Organizations not meeting this small business criterion should not submit a response.
Submission & Evaluation
Interested small businesses should submit a capability statement addressing the outlined technical areas of experience and expertise. Responses must include organization name, address, point of contact, business size, socioeconomic status, and UEI number. Teaming arrangements may be described. Responses will be used to determine the appropriate acquisition strategy, including potential small business set-asides. This notice does not guarantee a future solicitation.
Contact Information
- Primary Contact: RANJIT, THERESA A (theresa.ranjit@nih.gov)
- Submission Email: Theresa.Ranjit@nih.gov and Noor.Shakeel@nih.gov