--- title: "Authoring | Trelice" description: "Trelice is an ICH M11-native platform for sponsors, CROs, and research sites to author clinical trial protocols and generate aligned downstream documents." canonical_url: "https://www.trelice.com/products/authoring" --- Product / 01 # 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. [Book a demo](/contact) [See pricing](/pricing) app.trelice.com / studies / RSV-2025-037 / protocol ![Trelice authoring app showing the Clinical Study Protocol title page](/images/TreliceScreenshotMain.png) 01 / Per-field regulatory rationale ## 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 ![Trelice regulatory references for the IND Number field: 21 CFR 312 marked required for the FDA, EU CTR Annex I for the EMA, and the PMD Act for the PMDA](/images/app/06-regulatory-references.png) 02 / Roles, dates & accountability ## 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 and what’s in review, and flags 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 ![Trelice pending tasks: authoring and review tasks per protocol section with assignee, due date, overdue flags in red, and a reminder bell](/images/app/03-pending-tasks.png) 03 / Update once, update everywhere ## Change an endpoint. *Watch every relevant section update itself.* Trelice’s protocol modules are intelligently linked together. When you revise a field that appears in multiple protocol sections (a primary endpoint, say), the platform propagates the change to every other relevant section (synopsis, eligibility, objectives, statistical analysis), so nothing falls out of sync. - Repeating data tagged by the system - Bidirectional links between all related fields - Change-impact preview before you commit ![Trelice: one field linked across multiple protocol sections so editing any one updates all](/images/TreliceScreenshotGoldenThreads.png) 04 / Review and approve in one place ## Assign reviewers, and *watch the approvals roll in.* No more frantically chasing down team members via email to make sure they reviewed the protocol. Simply assign reviewers in Trelice and watch the approvals roll in. Export the review and approval audit trail with the click of a button to demonstrate regulatory compliance. - Assign named reviewers and approvers per section - One-click export of the full review & approval audit trail - Electronic signatures on every sign-off, architected for 21 CFR Part 11 ![Trelice review process for a protocol section: three review levels, each reviewer’s approval status, due dates, and the assigned writer](/images/app/07-review-process.png) 05 / Automated QC and formatting ## Submission-ready formatting, *checked automatically.* Once you’ve finished writing, Trelice automatically QCs your protocol for consistency, adds bookmarks and in-document linking, and puts all formatting in submission shape. What used to take medical writers weeks is now done automatically in minutes. - Automated consistency and terminology checks - Bookmarks and in-document cross-links added for you - Submission-ready formatting applied in minutes, not weeks Automated QC report Consistency & terminology Passed Cross-references & links Resolved Bookmarks & navigation Added Submission formatting Normalized 06 / Live document preview ## See your protocol in Word or PDF, *live as you type.* Prefer to see your protocol in Word or PDF as you go? The live document preview updates as you type. Export at any time to get the fully-formatted, regulatory-compliant Word or PDF document in real time. - Faithful Word and PDF rendering with your organization’s template - Track changes, comments, and redlines preserved on export - One-click submission-ready PDF with bookmarked sections ![Trelice protocol editor beside the live PDF preview, with page thumbnails and the rendered synopsis](/images/app/09-live-preview.png) Workflow ## Synopsis to IND-ready, *without the three-week sync cycle.* 01 ### Import synopsis Paste your synopsis or upload a Word draft. Trelice extracts endpoints, eligibility, and design parameters into structured fields. 02 ### Author with rationale Fill each section in the structured editor. Citations surface inline. Reviewers see exactly what regulation every choice answers to. 03 ### Propagate changes Edit a primary endpoint once. Eligibility, SAP, ICF, and screening forms update automatically, with change-impact preview. 04 ### Export to regulator Render the Word document with your TransCelerate template. Submission-ready PDF with one click. Integrations ## Fits into your existing stack. VE ### Veeva Vault Export approved protocols to your Vault of record. SH ### SharePoint Sync final documents to your sponsor’s repository. OK ### Okta / Azure AD SSO with the identity provider you already run. DO ### DocuSign E-signatures on approval, architected to support 21 CFR Part 11 requirements. ## Where are you with ICH M11 today? Six questions about how a protocol moves through your organisation now. You will see where you stand before you give us anything. 1. Are your protocol section headings and order already aligned to ICH M11? 2. Is there one place where the current, approved version of a protocol always lives? 3. Does each section have a named writer and a named reviewer before drafting starts? 4. When a protocol changes, do the informed consent form and site documents get regenerated from it rather than edited separately? 5. Can you show an auditor who changed which section, when, and who approved it, without assembling it by hand? 6. Do you know today which protocols are waiting on which reviewer? ## See it on *your* protocol. Bring a synopsis. We'll walk you through Authoring in 30 minutes. [Book a demo](/contact)