Inspection-ready every day.
With the team you already have.
SmartTMF is the AI trial master file that files, checks and scores your documents as the trial happens — clinical trial software built for small CROs, sites and biotech sponsors.
readiness
Trial capacity quietly disappears into document admin
Across 524 sponsors and CROs, misfiled and missing documents were one of the most-cited operational pain points. The TMF is where they pile up.
Source: Veeva Unified Clinical Operations Survey, 2020 ↗In the EMA's 2024 GCP inspection findings, incomplete or poorly maintained trial master files topped every sub-category. Gaps show up in front of an inspector.
Source: EMA GCP IWG Annual Report, 2024 ↗Documentation gaps are a common cause of the delay that pushes out database lock. Contemporaneous filing is cheaper than the pre-audit scramble.
Source: Tufts CSDD, Cost of a Day of Delay, 2024 ↗One platform. Three products. Zero scramble.
Three steps to a TMF that files itself
Email, upload or connect your systems. Site packs, ethics letters, delegation logs — as they arrive.
SmartTMF classifies to the TMF Reference Model, spots duplicates and gaps, and queues each decision for one-click human confirmation.
A live readiness score per study, country and site — with missing-doc chase lists your team can act on today.
Every AI decision is suggested, human-confirmed, and audit-trailed — ALCOA++ by design.
New vendor, serious controls — here's what you can verify before you book a call
We're early, and honest about it. Instead of a wall of logos we can't yet claim, here's the substance a compliance-first team can check today.
Compliance is the architecture, not an add-on
21 CFR Part 11, GDPR, HIPAA, ICH-GCP E6(R3) and ALCOA++ data integrity are built into the core — audit trails, e-signatures and access controls on every clinical record.
See the Trust Center →AI you can defend to an inspector
Every AI classification is advisory: it carries a confidence score, a named person confirms it, and the decision is written to an immutable audit trail. Consistent with GDPR Article 22 — no automated decisions on your data.
A founding cohort, not a logo wall
We're onboarding a small group of CROs, sites and sponsors for 2026. You work directly with the team building the product and help shape the roadmap — no call-centre, no SDR scripts.
UK-built and security-first
DataTreasure Ltd, registered in the United Kingdom. Field-level AES-256 encryption, TLS 1.3 in transit, and SOC 2 and ISO 27001 certification programmes in progress.
Questions CROs ask us
SmartTMF is AI trial master file software. It classifies incoming trial documents against the TMF Reference Model, detects missing or duplicate documents, and maintains a live inspection-readiness score — with every AI suggestion confirmed by your team and captured in a full audit trail.
Yes. Electronic signatures, tamper-evident audit trails, access controls and validated workflows are built in — alongside GDPR, HIPAA and ICH-GCP E6(R3) alignment. Documentation is available in the Trust Center.
That's exactly who it's for. Onboarding takes days, and the AI does the work that would otherwise need a dedicated TMF team.
No. The AI suggests classification and flags issues; a named human confirms every action. You get the speed of automation with the accountability GCP requires.
A pilot study can be live within a week. Book a 20-minute call and we'll scope it on one of your real studies.
See it on one of your own studies
Pick a slot — the calendar is live. We'll walk through SmartTMF on a real study structure, not slides.