AI drafting and QC in Microsoft Word
Country and Site Informed Consent Forms
A local consent form adapts the master form to one country’s requirements without drifting from the protocol.
See Local consent forms drafted in Word
A short demo on a fictitious study and product. In a live demo we walk through the same workflow and answer your questions about sources, review and deployment.
Read the transcript
A local consent form adapts the master form to one country's requirements. 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.
Can AI adapt a master ICF to country requirements?
Yes. PharmAssist drafts the country or site consent form from the master ICF and the local requirements your team supplies, such as insurance, data protection and ethics committee wording. Each statement cites its source, and local requirements that are not yet covered are flagged for review.
How this document gets written today
Global studies need country and site versions of the consent form, each with local legal, insurance, data protection and ethics committee requirements.
Keeping dozens of versions aligned with the master and with each amendment is repetitive, error-prone work.
What your team can work on
Your master ICF plus the country and site requirements your team supplies.
Country ICF drafts
Draft the local version from the master ICF with local requirements added in the right sections.
Local requirement coverage
Check that each supplied local requirement appears in the draft.
Master alignment
Citations show which master section each statement comes from.
Amendment propagation
Carry a master change into each local version.
How it works for Local consent forms
Choose local ICF
Select Country or Site ICF and the country.
Add sources
Upload the master ICF and the local requirements.
Draft and check
Draft and review citations and requirement coverage.
Review
Insert into Word and route through country and ethics review.
What it drafts from
Select the approved sources for the task. Data handling follows the deployment and model-service configuration agreed with your team.
- Approved master ICF
- Country requirements and section map
- Local insurance and data protection wording
- Site-specific instructions
What stays with your team
PharmAssist supports your document workflow. Interpretation, medical and regulatory judgement, approval and submission stay exactly where they are today, with qualified people and your existing review chain.
Choose GenText-hosted SaaS or a private deployment. Confirm access, data handling, model services and retention during supplier qualification.
Security and deployment detailQuestions we are asked about this document
Where do local requirements come from?
Your team or CRO supplies them. PharmAssist drafts from them and checks coverage; it does not decide what local law requires.
Can it keep many country versions in step?
Each version is drafted from the current master, so a master change can be carried into every local version.
Does it translate?
It drafts in the language of your template and sources. Certified translation stays with your existing providers.
Who reviews and approves the Local consent forms?
Your qualified specialists do. PharmAssist drafts and checks; scientific interpretation, medical and regulatory judgement, quality review and approval stay with your team and your existing review chain. Open questions and missing inputs stay visible in the draft until a person resolves them.
Does PharmAssist work inside Microsoft Word?
Yes. PharmAssist is a Microsoft Word add-in for Windows, Mac and Word on the web. You choose the document type, add your source files, review the outline and section drafts in a side pane, and insert approved text into the document you are already working on.
Where does our data go, and do we need a Veeva connection to begin?
Choose GenText-hosted SaaS or a private deployment. Data handling, model services and retention are confirmed with your technical owner during supplier qualification. A demonstration starts with fictitious documents and upload; connections to Veeva Vault or other source systems are scoped during implementation.
Teams that start here often widen to
Clinical trial documents
Informed Consent Forms
Draft master ICFs in plain language, grounded in the protocol.
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Clinical trial documents
Clinical Trial Protocols
Draft protocol sections from the approved synopsis and design decisions.
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Regulatory labelling
Local and Country Labels
Adapt core labelling to one country’s rules and approved wording.
Read more
Talk to us about Local consent forms
Tell us your role, source material and next document milestone. We will confirm the demonstration scope and define a paid pilot with your team.
Prefer email? alex@gentext.ai