AI Medical Writing Built for Medical Writers

Clinical study reports built to ICH E3 structure, clinical study protocols, statistical analysis plans, patient safety narratives, informed consent forms, and plain language summaries — of results, publications, and protocols. Each type is drafted from source files you already have. For the CSR clinical trial teams file at study end, that means the protocol, SAP, and tables/listings/figures; narratives draw on case data. The list is not a fixed menu. If a document type is not on it, your template and prompt set make it one — sections, numbering and house style are configurable, so clinical, regulatory, technical and plain-language documents all run through the same drafting and source-referencing workflow. See medical writing for how teams sequence them.

Yes, natively. LINK AI is a Microsoft Word add-in, so drafting and refinement happen inside the same document your team already reviews and signs off in — track changes, comments, your styles and your numbering all intact. That matters beyond convenience: version history stays in one place for QC and regulatory reviewers, and nobody has to reformat a draft after moving it between tools. There is no second application for writers to learn, and finished drafts land in the repositories you already use, including OpenText.

With regulatory document drafting AI, a human writer — not the model — is accountable for what ships. Drafted statements are referenced to the source material they came from, so review is verification against a citation rather than a judgment call. Every edit is logged and attributable, which gives you a change history you can show an auditor or inspector. A qualified writer verifies, refines and signs off before anything is released — “AI Enabled. Human Driven.™” is the operating rule, not a slogan. Clinical study report automation accelerates assembly; the model never holds sign-off authority.

No. LINK AI runs in a secured, closed architecture hosted on Azure: your documents and source data are used to draft your documents and nothing else. Client data is not used to train public models and is never shared between customers, and content is encrypted in transit and at rest. TrialAssure is ISO/IEC 27001:2022 certified by Intertek under UKAS accreditation and ISO 9001:2015 certified, GDPR-aligned with an EU contracting entity in Eindhoven, and a data processing agreement is available. Full detail sits in the Trust Center.

Then use ours. TrialAssure offers regulatory writing services on the same platform, so you can license LINK AI for your own writers, co-write with ours under your oversight and sign-off, or hand us the document list and receive verified drafts. Daiichi Sankyo runs plain language summaries that way — up to 80% faster delivery at ~50% lower cost per document, with the partnership renewed. Your team keeps approval authority in every model; what changes is only how much of the assembly work sits with us. See services or the case study.

Yes. AIMWC — TrialAssure’s AI-for-Medical-Writing Certification — is four live sessions that certify your writers on AI-assisted drafting, provided free of charge. It is cohort-based, and it teaches how to prompt, refine and critically review AI-drafted clinical and plain-language content, including where a writer has to intervene, so the certificate is about editorial judgment rather than tool clicks. It is open to your team whether or not you license LINK AI — the frameworks transfer to any AI writing stack. Configuration on your own templates and document types is handled separately, when we set LINK AI up with you. See AIMWC certification.

30+ countries now require every clinical investigation to include a lay summary of trial methods and results — and the list keeps growing. In the EU, the Clinical Trials Regulation makes a plain language summary part of the results a sponsor posts to CTIS, not an optional courtesy, and it is owed in the local languages of the countries where the trial ran. So a single study can generate a set of summaries rather than one document, on a clock that runs independently of the CSR. See plain language summaries.

Yes. Refinement is part of drafting rather than a separate step: a writer selects a section, prompts it in plain language — tighten this, use a different source table, make this readable for a patient audience — and reviews the revision before it enters the document. Because each section is generated against your template and its own source files, one section can be reworked without disturbing the rest of the draft. Nothing is applied silently: the writer chooses what to insert, and track changes records it like any other edit.

Every generated section carries references: drill down and LINK AI shows which source document — and which passage in it — was used to write that section, including which table a figure was pulled from. If it used the wrong table, point it at the right one and regenerate. That per-section traceability is what generic AI tools can’t give you without a chain of “where did you get this?” prompts.

No — LINK AI ships as a Microsoft Word add-in. Writers open the drafted document in Word, see the prompt and response behind each section in a side panel, refine in a chat-style exchange (“shorten this,” “use the week-12 table”), and insert the result. Track changes, your templates, your styles — nothing leaves the writer’s normal environment.

Yours. Upload your company templates — sections, numbering, house style — and LINK AI populates them from your source files (protocol, SAP, tables/listings/figures). The template defines the shape of the document and the prompts define what each section has to say, so a draft arrives in your format instead of a generic one a writer then rebuilds. New document types need a new template and prompt set, not new software; the platform is not hard-coded to any one format. Templates and settings are configured with you during implementation.

LINK AI integrates with OpenText, and drafting happens natively in Microsoft Word — so drafts live in the tools and repositories your writers already use. A document pulled from your system into Word stays an ordinary Word file; the add-in adds drafting and source references rather than a parallel place to store documents. We name only the integration we have, OpenText. If you run something else, the practical question is how your writers get documents into and out of Word, and that is worth scoping against your environment during the demo.