A protocol is read by ethics committees, regulators, sites and statisticians, and each finds something different wrong with it. Drafting to a structured template and testing it against reality first is where amendments are avoided.
AI clinical trial protocol drafting turns a sponsor’s synopsis, prior protocols and the published evidence into a first draft structured to the ICH M11 clinical electronic structured harmonised protocol (CeSHarP) template, with each section linked to its sources. The medical lead, statistician and regulatory lead edit and approve every section. The system writes the first version, not the final one.
Structure matters beyond tidiness. A protocol held as structured content can be checked against itself: the schedule of activities against the endpoints, the eligibility criteria against the population the objectives describe. It also feeds downstream documents, such as the informed consent form and the CTIS submission, without retyping.
objectives, design, population
prior protocols, registries, literature
structured sections with links
consistency and eligibility realism
medical, statistical, regulatory sign-off
design choices returned, not guessed
It can write a solid first draft from a synopsis and your prior protocols, and check it for consistency, which removes much of the assembly. It cannot own the scientific design or the ethics of the study. The sponsor’s medical, statistical and regulatory leads decide the content and sign the protocol, and the draft is built to make their review fast.
ICH M11 is the harmonised guideline for a clinical electronic structured harmonised protocol, known as CeSHarP. It defines a common template and a technical specification so protocol content can be exchanged and reused as structured data. Drafting to it from the start makes downstream reuse, such as registry entries and consent forms, much easier.
It can reduce the avoidable ones: internal inconsistencies, schedules that do not support the endpoints, and eligibility criteria far stricter than comparable trials. It cannot prevent amendments driven by new safety information or changed strategy. We measure the effect against your own amendment history rather than quoting a general figure.
What we built, what stage it is at, and a link to the live thing wherever there is one.
yourOS is an operating system with an AI at its heart. You talk to it like a person, out loud or typed. It makes your calls, plans your days and works on your projects with a crew of agents, on your own private server. Our own product, built from the first commit; the waitlist is open.
Website, backend and app assets for Sonora, a free AI sound-therapy app on iOS and Android published by Cognitive AI.
Brand, website, prototype, apps on five platforms, the AI backend and the algorithm-intelligence pipeline for Podswap, a social growth engine that runs without a human in the loop.
In closed beta: Roxy, a private AI assistant with permanent memory running on infrastructure the user owns. Brand, site, product, backend and conversational design.
Live at coherence.com: brand identity generated with AI agents we directed, the motion system and website for the group behind Sonora, AboutAI, WakeUp and MudShadows. Agent work remains in build.
Live at domainbooth.com for DomainBooth, a premium domain brokerage: a new animated mark, every page redesigned and rebuilt with designed mobile layouts, and a custom CMS for its sales record, featured names, press and enquiries.
Bring a synopsis and two prior protocols. We will show what a structured first draft looks like.
30-minute technical call · no deck