Protocol StudioClinical Development

The protocol and the synopsis say different things.

Protocol Studio writes the protocol family from one source. Change an endpoint and every document that quoted it is flagged.

Data secure in your cloud21 CFR Part 11-awareSOC 2 Type II (in progress)ISO 27001 (in progress)Your data never trains foundation modelsTrust and security →

What it does.

  • The protocol and its whole family.

    Protocol, synopsis, amendments and informed consent, authored from one source of truth and to your template.

  • One change, every affected document.

    Change an endpoint and every document that quoted it is flagged, with the passage that needs to follow.

  • Statistical analysis plans and development plans.

    Drafted against the protocol they belong to, so the two cannot drift apart in review.

  • Investigator brochures and per-site packages.

    The brochure carries the current safety picture rather than last year's, and site and country documents are assembled per requirement, consent included.

Start where it hurts.

We'll run it live on a section of your own work.

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Your data stays in your environment. Customer data never trains foundation models.