Medical writing expertise, amplified with AI.

No. TrialAssure LINK® AI supports writers rather than replacing them — it produces the first draft, your writers make the judgment calls and sign off, and the audit trail records who did what. It gives writers back the hours that mechanical drafting used to consume, so their capacity moves to the interpretation and argument only they can do.

Fully. LINK AI builds from industry templates like TransCelerate and CDISC or from your own document specifications — section order, numbering, terminology, table conventions, and styling. The specification is supplied once and applied across the whole document family, so a CSR, its patient safety narratives, and its plain language summary stay consistent instead of drifting between authors. Drafts arrive in your house style rather than a generic shape you would have to rebuild. Where a house convention is undocumented or ambiguous, your writers settle it in review — the template governs structure and format, never scientific judgment.

Yes. LINK AI runs as an assistant inside Microsoft Word, so writers draft, review, and edit in the workspace and file formats they already use. You point it at your source content and your template, drafted statements carry their source references alongside the text, and tracked changes and comments behave exactly as your reviewers expect. There is no separate application to learn, no copy-paste between tools, and no export step that could strip formatting or break numbering. The file your writer signs off on is the file the AI drafted into.

LINK AI drafts only from the source content you give it, and links every statement back to where it came from. General-purpose chatbots invent plausible-looking citations because they are predicting text, not reading your data; LINK AI is constrained to the source documents you supply, and each drafted statement carries the reference it was built from. A reviewer can follow any claim to its source, so quality control becomes a check against source rather than a hunt for it. Judging whether a referenced statement is the right one to make stays with your writer.

No. LINK AI runs in a closed architecture: the source content you provide is used only to draft your documents, never to train public models and never shared with other customers. The platform is Azure-hosted, with encryption in transit and at rest. TrialAssure is ISO/IEC 27001:2022 certified by Intertek under UKAS accreditation, certificate 0251375, and ISO 9001:2015 certified for quality management. Handling is GDPR-aligned and HIPAA-aligned, TrialAssure B.V. in Eindhoven is available as the EU contracting entity, and a DPA is available. The full security posture and certifications are documented in the Trust Center.

The core regulatory and scientific set: clinical study reports, patient safety narratives, study protocols, plain language summaries, and informed consent forms. Each is drafted from the source content you supply and shaped by your template for that document type, so one tool covers the medical writing clinical trials require, instead of every document needing its own setup. Patient-facing documents like plain language summaries run through the same source-referenced workflow as the regulatory ones, which is what keeps a summary faithful to the report behind it. Documents with no clinical source to draft from sit outside the intended scope.

With medical writing AI in the workflow, CSR drafting hours were cut ~90% at a top-10 pharma, against the 280 hours a manual CSR assembly typically takes, and Daiichi Sankyo delivers plain language summaries up to 80% faster at ~50% lower cost per document. The exact gain depends on document type, source quality, and how much review your SOPs require. The saving comes from mechanical work: pulling numbers from tables, stitching sections, formatting to template. Review time does not disappear — writers still read, judge, and sign off — so expect a shorter drafting phase, not a uniformly shorter process. See the AI-augmented CSR case study for the workflow in detail.

Accountability stays human. AI drafts, but your writer edits, decides, and signs off, and every change is captured on a time-stamped audit trail with attributable authorship — who drafted, who edited, who approved, and when. Part 11 expects records to be attributable, traceable, and reviewable; ICH E6(R3) places responsibility for trial quality on the sponsor rather than on a tool. LINK AI is built around both: the human remains the author of record, and the evidence of that lives in the document rather than in someone’s recollection. Validation and your own SOPs remain yours to own — we supply the traceability they rely on.

A medical writing agency is capable but tied to writer availability, carries premium pricing, and takes institutional knowledge offsite. LINK AI keeps drafting — and the knowledge behind it — with your own team, adding capacity without adding headcount. You can also blend the two: license the software, co-write with our writers, or hand us the backlog.

Through AIMWC, our free AI in Medical Writing Certification. It runs four weeks, cohort-based, with four live weekly 60-minute sessions plus on-demand replays, covering human oversight, QA against source, prompting, and where a judgment call should never be delegated to a model. It is written for practicing medical writers and their managers rather than for IT, and it is deliberately not a product course — the practices transfer whatever tooling a team ends up using. Certifying the team matters because the compliance model puts the writer, not the software, in the accountable seat.

Yes. Beyond licensing the software, we offer professional medical writing services: our writers co-write alongside your team or take a backlog end to end — the same model Daiichi Sankyo runs — all on the same LINK AI platform, so templates, drafts, and audit trail stay consistent whoever is holding the pen. Sponsor sign-off remains yours in every arrangement; we never become the author of record. You can also move between the three as the pipeline shifts: license during steady state, co-write through a submission peak, hand over the backlog when volume outruns headcount. Explore the options under medical writing services.