Protocols, written with regulatory intelligence.
A structured clinical-trial protocol authoring system. Replaces Word-template chaos with a field-level editor where every entry carries its citation, every change propagates, and the Word output renders live.
Every field knows which regulation it answers to.
When a writer fills in the primary endpoint, a statistical analysis population, or an exclusion criterion, Authoring surfaces the specific regulation or guidance section that requires it — and why the value they entered satisfies it.
- ICH E6, E8, E9, M11 citations linked at the field level
- FDA, EMA, and PMDA guidance references maintained by our regulatory team
- Audit trail captures rationale with every save
Assign every section an owner and a deadline.
With the regulatory scope set, hand each protocol section to a named owner and a due date. Trelice keeps every assignment in one pending-tasks queue — showing who holds each section, what’s in review, and flagging overdue work in red so nothing quietly slips.
- Section- and step-level ownership by named role
- Due dates with automatic overdue flagging
- One pending-tasks queue across the whole protocol
Change an endpoint. Watch every dependent section update itself.
Trelice’s protocols are structured, not just typed. When you revise a primary endpoint, the platform propagates the change to eligibility, statistical analysis, informed consent, screening forms, and IRB narratives — and flags every reviewer who needs to re-approve.
- Bidirectional links between all structured fields
- Change-impact preview before you commit
- Approval chain automatically re-routes
The output document updates as you type.
Most authoring tools make you export, open Word, and hope the formatting survived. Trelice renders a fully-formatted, regulatory-compliant Word document in real time — beside your editor, never out of sync.
- Faithful Word rendering with your organisation’s template
- Track changes, comments, and redlines preserved on export
- One-click submission-ready PDF with bookmarked sections
Synopsis to IND-ready, without the three-week sync cycle.
Import synopsis
Paste your synopsis or upload a Word draft. Trelice extracts endpoints, eligibility, and design parameters into structured fields.
Author with rationale
Fill each section in the structured editor. Citations surface inline. Reviewers see exactly what regulation every choice answers to.
Propagate changes
Edit a primary endpoint once. Eligibility, SAP, ICF, and screening forms update automatically, with change-impact preview.
Export to regulator
Render the Word document with your TransCelerate template. Submission-ready PDF with one click.
Fits into your existing stack.
Veeva Vault
Export approved protocols to your Vault of record.
SharePoint
Sync final documents to your sponsor’s repository.
Okta / Azure AD
SSO with the identity provider you already run.
DocuSign
21 CFR Part 11–compliant e-signatures on approval.
See it on your protocol.
Bring a synopsis. We'll walk you through Authoring in 30 minutes.
Book a demo