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SDTM · in beta

The Clinical Trial Intelligence Platform

SDTM that arrives with its own proof.

The same proof, engineered for every stage of the study.

Every deliverable is built twice by independent teams, compared programmatically, and frozen by dual sign-off — with the evidence attached to the exact content that was approved. One connected study, one method, from clinical intent through submission delivery.

Limited beta. Technical walkthrough with the team building it.

EDC intake ⟶Study pipeline
  1. 01Building
    Protocol · SAP
  2. 02In beta
    SDTMDEVQC
  3. 03Next
    ADaMDEVQC
  4. 04Building
    TFLs
  5. 05Building
    Submission

Built in pipeline order. SDTM first because everything downstream inherits it.

The method

The most expensive work to double-program is the work we automate — and prove.

  1. 01

    Two independent builds, compared automatically.

    Every deliverable is built twice by separated teams and the outputs are compared programmatically. Agreement is recorded as reviewable evidence — not a pass/fail you have to take on faith.

  2. 02

    Independence that’s actually enforced.

    Development and QC can’t see each other’s work. That’s what makes the second answer worth having.

  3. 03

    Dual sign-off freezes the deliverable.

    When a deliverable is signed by both sides, it’s frozen — with the signature record attached to the exact content that was approved.

Designed for regulated work.

Electronic signature records capture signer identity, the exact content hash signed, and a timestamp — append-only, enforced by the database, so the record of who approved what cannot be rewritten after the fact. Signature gates sit at protocol approval and the SDTM freeze, on a signing primitive designed to extend to further document workflows.

Sponsor, study, and workspace boundaries are enforced by database row-level security that fails closed — not by UI filtering. Development and QC are read-walled server-side, so the second answer is genuinely independent.

Beta access

One method, applied down the whole pipeline.

Independent, compared, signed — the same discipline at every stage, wherever the study is in flight.

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