DataFit Operation and Maintenance

The Food and Drug Administration's Center for Drug Evaluation and Research seeks contractor support to install, update, support, and develop enhancements to DataFit, its data standards validation platform for clinical trial and non-clinical data analysis, with quotations due August 25, 2026 and questions due August 17, 2026.

Place of performance is the contractor's site, with required meetings conducted at FDA's Washington, D.C. Metro-area offices. The NAICS code is 541519, Other Computer Related Services; PSC code is DA10. This is a combination Firm-Fixed Price and Labor Hour purchase order under FAR Part 12 for commercial items, issued as an RFQ with no set-aside. The base period runs September 28, 2026 through September 27, 2027, with two optional 12-month extension periods and a government option to extend for up to an additional six months under FAR 52.217-8.

DataFit is built on Pinnacle 21 Enterprise, a CDISC clinical trial data standards compliance software, with FDA-specific business rules, tools, and system integrations. Required key personnel are Bioinformatics Analyst III (6+ years applied bioinformatics experience, 4+ years medical or public health informatics), Project Manager (7+ years), Software Developer II, IT Technical Lead Expert (3+ years), Technical Writer (2+ years), and Trainer/Facilitator. All contractor personnel must comply with extensive security requirements including Tier 2 background investigations, PIV card issuance, Section 508 accessibility standards, NIST standards, encryption protocols, continuous monitoring, and one-hour incident response procedures.

Award goes to the responsible quoter representing best value using lowest price technically acceptable methodology, weighted as Prior Experience (Factor 1) and Technical Approach including Management Approach (Factor 2) more heavily than Price (Factor 3). Technical quotations may not exceed 15 pages plus three-page resumes per proposed personnel. Quotations are valid for 60 days. Payment terms are Net 30 days after government acceptance via the Invoice Processing Platform.