Roll them out together or one at a time. Either way, the data model is shared, the audit trail is unified, and the regulator sees one system — not four.
Built around the DIA TMF Reference Model v3.3.1 with quality checks at upload, not at lock. The workflows match how clinical-ops teams actually work: drag-drop, draft-and-finalise, redact, version, sign.
Replace the activation tracker, the SharePoint folder, and the email thread with a single workspace where every team — sponsor, CRO, vendor, site — sees what's next and who owns it.
Define the protocol's critical-to-quality factors once. Monitor them across every site, with triggers that fire on drift — not after the fact. Visit reports, action items, and source documents share the same workspace.
Document organisation that mirrors how regulators expect the dossier. Electronic signatures with long-term validation. Health-authority correspondence linked to the artefacts it references.
Designed and validated to support GxP-regulated clinical trials worldwide:
Validation packages, IQ/OQ/PQ documentation, and our Quality Manual are available under NDA to qualified prospects and customers. Infrastructure runs in AWS regions you choose: us-east-1, eu-west-1, or eu-central-1.
Per study, per module, with portfolio discounts for sponsors and CROs running multiple programs. We don't publish a price list because no two clinical programs look the same. Talk to us about your protocol and we'll quote in writing within a week.
Most customers go live in 4–8 weeks for a single study. Larger CRO rollouts typically take 12–16 weeks including SOP alignment and validation. Every implementation includes a named clinical-operations consultant from our team — not a project manager.