Trelice Information

Trelice is where clinical trial protocols get written — and where everything that depends on them stays consistent. Authoring comes first. Instead of starting from a blank document, you write in a structure that's regulatory-led by design, aligned with the ICH M11 structured protocol standard, so the framework guides what belongs where rather than leaving it to memory and past templates. And because a protocol's parts are deeply interdependent — objectives and endpoints, the schedule of activities, eligibility criteria referenced in a dozen places — Trelice keeps them consistent as you write and revise. Change something once and it stays aligned everywhere it appears, instead of drifting from section to section. The protocol comes together faster and holds together better. From there, that same consistency extends outward. The approved protocol becomes the single source for the documents that follow — informed consent forms, IRB/EC Q&A, visit worksheets, redacted registry versions — which generate from it and stay in sync when it's amended. No more tracking down and reconciling a dozen files by hand every time the protocol changes. It's built for regulated work from the ground up, with 21 CFR Part 11 audit trails, so it fits the standards your quality and regulatory teams already hold. And it was shaped in close collaboration with clinical trial practitioners, which is why it solves the specific daily problems of protocol authoring rather than generic ones. Trelice is live and in active testing with early clinical teams. If you author protocols or run trials, we'd like to show you what it does.