Medical Writing
Draft protocols, informed consent forms and clinical study reports with your study sources available for review.
Explore clinical authoringPharmAssist by GenText
Your evidence.
Your expertise.
A better first draft.
PharmAssist is a Microsoft Word add-in from GenText for AI-assisted medical writing and regulatory document QC. Bring your approved sources into the draft. Keep scientific judgement and approval with your team.
Built on enterprise delivery experienceGenText has delivered pharmaceutical authoring workflows at a US-listed pharmaceutical company.
Works in Microsoft WordDraft, inspect findings and review within the document.
Start with one workflowAgree the scope, sources and acceptance criteria for a paid pilot.
See it in Word
Watch PharmAssist draft a regulated document.
One minute: a DSUR drafted in Microsoft Word from its sources, on a fictitious study and product. Recorded demos like this cover 20 of the 20 document types.
Read the transcript
A development safety update report pulls serious adverse event data from across your clinical trials, every year. PharmAssist works inside Word. Choose the document type and add your source files. It lays out the document's outline, right in Word. Pick a section, and PharmAssist drafts it from your sources. Review the draft, then insert it into your document. You can also ask questions in chat. Answers come from your own files, and show which ones they used. From your sources to a draft in Word, ready for expert review. Book a demo at gentext.ai/pharma.
Check it in Word
Check a label against its core data sheet.
Under a minute: PharmAssist checks a fictitious US label against its company core data sheet, finds one conflicting dose and suggests the change as a tracked change in Word. Your reviewer decides whether to apply it.
Read the transcript
Check a label against its core data sheet, in Word. Open the label in Word, choose the document type, and add the core data sheet as the source. Choose a check. One example: cross-document consistency. PharmAssist finds one conflict. The label gives a maximum dose of 80 milligrams. The core data sheet says 40. Go to the sentence in Word, then apply the suggested change as a tracked change. Only the number changes. You review every change in Word. Book a demo at gentext.ai/pharma.
For the people who own the document
Different responsibilities.
One place to draft and review.
Choose the workflow your team needs. We will shape the demonstration around your documents, review process and next milestone.
Clinical Operations
Keep participant information aligned with the protocol and identify what an amendment changes.
Explore informed consentRegulatory Affairs
Draft label updates from core content and review the differences across regional documents.
Explore labellingSafety & Pharmacovigilance
Bring reporting-period inputs into DSUR and PBRER drafts, with checks for missing and unsupported content.
Explore safety reportsMedical Information
Prepare responses and FAQs from approved evidence, with review and approval in your team’s hands.
Explore medical informationCMC, Statistics & Scientific Affairs
Support specialist documents with their own structures, source requirements and review checks.
Explore specialist workflowsTwenty document types in nine families
Across the pharmaceutical writing lifecycle.
Explore the document scope below. Your demonstration and pilot establish the exact templates, checks and delivery requirements for your team.
Regulatory labelling
Safety and periodic reports
Clinical trial documents
Medical information
Scientific communications
Real-world evidence
Biostatistics
Nonclinical
Regulatory CMC and quality
From source to review
A working session with your document owners.
Start with a demonstration using synthetic material. Agree how a pilot will use your approved sources, and what a successful result must show.
The underlying GenText platform has been used to deliver labelling, DSUR, REMS and informed consent workflows for a US-listed pharmaceutical company. PharmAssist’s deployment, document scope and validation requirements are established for each new customer.
Bring the evidence
Upload the sources and templates you select. Confirm the relevant versions and identify missing inputs before drafting.
Draft and inspect
Generate sections in the document’s structure. Review the source context and QC findings, including unsupported content and inconsistencies.
Keep experts in control
Review in Word, resolve findings and approve through your established process. Measure the pilot against the criteria you agreed.
Deployment that fits your requirements
Hosted or private.
Scoped with your team.
Evaluate GenText-hosted SaaS or a private deployment. Confirm identity, data handling, model services and retention with your technical owner.
Demos start with document upload. Veeva and other enterprise connections are scoped during implementation.
Begin with a paid pilot.
One workflow, agreed source material and a defined review team. Establish quality and practical value before expanding across your document estate.
Questions
AI for regulated writing, answered plainly.
What is PharmAssist?
PharmAssist is a Microsoft Word add-in from GenText for AI-assisted medical writing and regulatory document QC. It drafts regulated pharmaceutical documents section by section from the approved sources you select. The pane lists the files used for the draft and displays candidate source passages where it finds a match; review those passages against the original source. Protocols and clinical study reports go into Word with citations. It flags missing inputs and numbers that do not appear in the sources for expert review.
Which documents can PharmAssist draft?
Labelling (US Prescribing Information, EU SmPC, package leaflets, local labels), safety reports (DSUR, PBRER, PSUR, REMS), clinical documents (protocols, informed consent forms, clinical study reports, patient narratives), medical information responses, publications, plain language summaries, RWE protocols, statistical analysis plans, nonclinical overviews and CMC Module 3.
Can AI write regulatory documents?
AI can draft regulatory documents for expert review. The useful question is whether a reviewer can check the draft against its sources. PharmAssist drafts from the sources you add and lists the files each draft used. Reviewers compare the draft with the original sources before approval. It marks missing information [MISSING] for your team to supply and rates each section for the risk of unsupported content. Qualified people review, decide and approve.
How is PharmAssist different from a general AI chatbot?
It works inside Word on your document, follows the structure of the document type, uses your selected sources to draft sections for expert review, and runs checks for completeness, terminology, content the sources may not support and numbers that do not appear in the sources. Chat answers questions about your document and sources and names the files each answer came from.
Is our data used to train AI models?
Data handling, model services and retention are agreed with your technical owner during supplier qualification, for GenText-hosted SaaS or a private deployment. Ask us for the current detail in writing.
How do we start?
Watch a demo, then request a live demonstration on fictitious documents. If it fits, we agree one workflow, the sources, the review team and the acceptance criteria for a paid pilot.
Show us where the document work gets difficult.
Tell us your role and the document you want to discuss. Alex Charles will arrange a focused demonstration and help scope a paid pilot.
Prefer email? alex@gentext.ai