Pilot
Verixa
The system of record for statistical-programming validation. A 21 CFR Part 11 audit trail with independent double-programming and resource planning, across whatever computing environment you already use.
Clinical-data tooling that takes statistical programming from spec to a submission-ready Clinical Study Report, audit-trailed throughout. Explore each module below and book a pilot.
Five tools that work together, each available for a pilot today.
The system of record for statistical-programming validation. A 21 CFR Part 11 audit trail with independent double-programming and resource planning, across whatever computing environment you already use.
Submission-ready CDISC SDTM in days, not weeks. One canonical mapping spec, dual R and SAS output, and define.xml, with 21 CFR Part 11 audit by construction.
CDISC ADaM analysis datasets derived from frozen SDTM, with propose-only AI agents, human approval at every gate, deterministic fallbacks, and matching R and SAS output.
Tables, Listings, and Figures from one analysis spec, with cell-level provenance and identical Python, R, and SAS output, while patient data never leaves your boundary.
Assemble the ICH E3 Clinical Study Report from your TLFs, with AI-drafted section narratives from metadata only, a medical-writer review loop, and cited provenance to every supporting table.