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.
The 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.
Keeping up with regulations, so you don’t have to.
Tell Trelice where your trial will run, and the protocol reshapes itself to every regulator you select — adding the fields each jurisdiction requires and citing the exact regulation behind every one, so you can read the source yourself.
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.
What used to take a medical writer three weeks takes three minutes. Drift is no longer a risk; it's structurally impossible.
- Bidirectional links between all structured fields
- Change impact preview before you commit
- Approval chain automatically re-routes
The final protocol 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.
What you approve is exactly what goes to the regulator. No surprises, no post-export clean-up.
- Faithful Word rendering with your organisation'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, golden-thread consistency, live Word preview.
Explore AuthoringICF
Generates site-, jurisdiction-, and population-specific consent forms directly from the approved protocol. IRB-ready, auto-regenerating.
Explore ICFBuilt for regulators, not retrofitted for them.
For the teams who can’t afford to wait for a nine-module suite to add one more feature.
Small & mid-cap biotechs
Running 1–15 concurrent trials. Lean medical writing teams. Need to move from synopsis to IND-ready protocol in weeks, not months — without hiring a regulatory affairs army.
Focused CROs
Therapeutically specialised contract research organisations. Need a specialist tool they can standardise across sponsors — not a suite that forces a rip-and-replace.
See a protocol draft itself in thirty minutes.
Bring a synopsis. We’ll walk through Authoring together — regulatory rationale, golden thread, live Word preview, and downstream ICF — on your actual study.
Book a demo