Statistical and Data Coordinating Center (SDCC) for Clinical Research in Infectious Diseases

The U.S. Government seeks small‑business sources to establish and manage a Statistical and Data Coordinating Center (SDCC) that will support NIAID’s extramural infectious‑disease clinical research portfolio. The SDCC must provide a 21 CFR Part 11‑compliant data management system, statistical design and analysis for Phase 0‑4 trials, specimen tracking, secure data storage, training, and AI‑enabled tools under human oversight. The effort is expected to require about 60 full‑time equivalents per year for up to seven years, with optional expansion up to an additional 90 FTEs. Respondents must submit a capability statement (≤5 pages) by September 30, 2026. • 21 CFR Part 11‑compliant clinical data capture, storage, and reporting • Statistical design, analysis, and reporting for therapeutic, vaccine, and device trials • Development/maintenance of study websites, specimen tracking, and secure data repositories • Training of clinical site personnel and support for site data‑management assessments • Integration of AI tools with mandatory human review and privacy safeguards • Estimated effort: 60 FTEs/year (potentially up to 150 FTEs with options) for up to 7 years • Small‑business eligibility required (including HUBZone, SDVOSB, 8(a), WOSB, etc.) • Capability statement due 3 PM ET, September 30, 2026; submissions via email to the contracting officer.