Faster protocols,
fewer
amendments.
A purpose-built authoring platform for clinical protocols, where every field carries its regulatory rationale, every update ripples through the entire protocol, and downstream documents are effortlessly generated.
ICFs, redactions, screening forms and more — instantly ready, always up to date.
The protocol is only the start. Every document a trial derives from it is generated straight from your approved protocol — and the moment the protocol changes, each one flags for regeneration. No more rebuilding the same content by hand across five files and hoping they still agree.
Informed consent forms
Master, country, site, and population-specific ICFs generated directly from the protocol — IRB-ready, plain-language, and auto-regenerating.
Redacted protocols
Public-disclosure and transparency redactions applied automatically and consistently, ready for submission without a manual markup pass.
Screening & eligibility forms
Inclusion and exclusion criteria flow from the protocol into screening forms that stay in lockstep every time the criteria move.
Looking for more?
Need another document type generated from your protocol? Reach us and we'll add it to the pipeline.
Request a document typeThe protocol authoring platform clinical trials deserve.
Clinical trials teams stitch together Word templates, chase down regulatory citations, and re-sync every downstream document by hand. Every edit is an opportunity to drift out of compliance, incur additional cost, and delay study timelines.
Keeping up with regulations, so you don’t have to.
Tell Trelice where your trial will run, and the protocol reshapes itself to every country or region you select — adding the fields each jurisdiction requires and citing the exact regulation behind every one, so you can feel confident your protocol won’t be rejected due to compliance issues.
Built for regulators, not retrofitted for them.
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 — such as a primary endpoint — the platform propagates the change to every other relevant section: synopsis, eligibility, objectives, statistical analysis.
What used to take a medical writer three weeks takes three minutes. Drift is no longer a risk; it's structurally impossible.
- Repeating data tagged by the system
- Bidirectional links between all related fields
- Change impact preview before you commit
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.
Nothing reaches a regulator without the right eyes on it — every decision is captured with a 21 CFR Part 11 e-signature and a full audit trail.
- Assign named reviewers and approvers per section
- One-click export of the full review & approval audit trail
- 21 CFR Part 11 e-signatures on every sign-off
Submission-ready formatting, checked automatically.
Once you've finished writing, Trelice automatically QCs your protocol for consistency, adds bookmarks and in-document linking, and ensures all formatting is in tip-top shape for submission.
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
See your protocol in Word or PDF, live as you type.
Prefer to see what your protocol looks like in Word or PDF? No problem — Trelice features a live document preview that 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
You write the protocol, we generate the ICF.
The informed consent form has always been the hardest downstream document — plain language, legally binding, jurisdictionally varied, and rewritten every time the protocol shifts. Trelice automates it.
Authoring
The structured protocol authoring system. Regulatory rationale per field, intelligent linking, native approval flow, live document preview.
Explore AuthoringICF
Create master, country, site, and population-specific consent forms with the click of a button directly from the approved protocol. IRB-ready, auto-regenerating, and AI-driven to ensure the language is appropriate for patients.
Explore ICFFor teams who want faster time to first patient enrolled — with mitigated risk of operational errors and regulatory rejection.
Biotech / Pharma Sponsors
Running 1–15 concurrent trials. Lean development teams. Need to move from synopsis to IND-ready protocol in weeks, not months — without hiring an army.
CROs
Therapeutically specialized contract research organizations. Use Trelice to author full protocols where you offer that — or just to generate the ICF: import the sponsor's protocol and produce consent forms without standing up a million ops and country teams. Adapted to your client's needs, whether that's full protocol authoring, an amendment, or just derived document generation (i.e. ICF).
See a protocol draft itself in thirty minutes.
Bring a synopsis. We’ll walk through Authoring together — regulatory rationale, intelligent linking, native approval flow, live document preview, and downstream ICF — on your actual study.
Book a demo