Every module here is shipped.
No roadmap slides. These are the capabilities running in the product today — each one demonstrable live, and each one built for how IVD performance studies actually run.
Design, capture, clean
From protocol to clean data.
AI study designProtocol PDF in, reviewed eCRF draft out — forms, visit schedule and consent bindings. A human approves every change; AI never touches captured data.AI
eCRF designerNo-code forms with edit checks, computed fields and unlimited log forms. Published versions never change — every capture stays bound to its exact version.Versioned
Bedside captureiPad-first entry, online or offline, with repeat-measurement rules and device traceability — born from a real PT/INR self-testing study.Offline-ready
Queries & SDVOnly the raiser closes a query, and no one approves their own correction. Source data verification is tracked field by field — and editing a verified value voids its SDV.Data quality
Integrity
What makes it defensible.
E-signaturesFreeze → sign → lock: the investigator signs frozen data with password re-authentication, the signature binds a content hash, and a database trigger blocks further change. Withdrawal keeps the signature in history — audited, never deleted.Part 11-style
Audit trailA database trigger writes an append-only, hash-chained row for every insert, update and delete — and attaches itself to new tables, so coverage can't drift.Append-only
Access & tenancyRow-level security isolates every tenant inside the database; roles are configurable per study and per site, with enforced separation of duties.RLS
Operations & analysis
Run the study. Analyze in place.
RandomizationBuilt-in IRT assigns subjects to arms at enrollment — allocation stays inside the audited system instead of a spreadsheet.IRT
Specimen custodyChain of custody for samples from collection to result — designed for ISO 20916 performance studies where the specimen is the study.ISO 20916
Method comparisonBland–Altman, robust regression, PPA/NPA agreement and a readiness score — IVD statistics computed where the data lives, not after a hand-off.Statistics
ExportsCDISC SDTM domains, ODM 1.3 XML, real Excel workbooks, CSV and PDF casebooks — with explicit missing-value reasons ("not done" vs "not entered").Analysis-ready
Show, don't tell
Pick any module. We'll demo it live.
Every row above exists in the running product — from the AI draft review screen to the signature hash check.