Statistical and Data Coordinating Center (SDCC) for Clinical Research in Infectious Diseases
NIAID’s Division of Microbiology and Infectious Diseases seeks small business capability information for a Statistical and Data Coordinating Center (SDCC) to support extramural clinical research programs. The SDCC would provide 21 CFR Part 11-compliant clinical data management, statistical design and analysis for Phase 0–4 trials, study materials and websites, training, specimen tracking, secure data storage, and project/site management, with permitted AI use subject to human review and quality-control safeguards. The Government anticipates one contract award for a maximum seven-year period of performance, estimated at 60 full-time equivalents per year, with options for up to an additional 90 FTEs. Interested sources must demonstrate relevant expertise, personnel, facilities, past performance, and the ability to address all technical requirements, including at least three similar projects. This is a Small Business Sources Sought notice for planning and possible set-aside determination, not a solicitation for proposals.