AI drafting and QC in Microsoft Word
Clinical Trial Protocols
A protocol sets out exactly how a study will run, and every later document builds on it. PharmAssist drafts sections from the decisions your team has already approved.
See Clinical protocols 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 clinical protocol sets out exactly how a study will run, and every later document builds on it. 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 write a clinical trial protocol?
AI can draft protocol sections for expert review. PharmAssist drafts objectives, endpoints, design, population and intervention sections from your approved synopsis, design decisions and investigator’s brochure, using the ICH M11 structure or your template. It cites the source for each statement and checks that sections agree with each other. The clinical team owns the design.
How this document gets written today
Protocol writing turns a synopsis and a series of design meetings into a long, tightly cross-referenced document. Objectives, endpoints, the schedule of activities, eligibility and statistics sections all have to agree.
Amendments then ripple through the protocol, the ICF and the SAP. Finding every affected sentence is a common source of findings.
What your team can work on
ICH M11 structure or your sponsor template, consistent with ICH E6(R3) and E8(R1) principles; requirements confirmed at intake.
Protocol section drafts
Draft objectives and endpoints, study design, population, interventions and assessments from the approved synopsis and design decisions.
Cross-section consistency
Check that endpoints, visits and eligibility statements agree across sections and with the schedule of activities.
Amendment support
Draft amended sections and identify related ICF and SAP updates.
Study ID and source confirmation
Clinical types confirm the study ID and sources before drafting, so the draft never mixes studies.
How it works for Clinical protocols
Choose protocol
Select Clinical Trial Protocol and confirm the study ID.
Add sources
Upload the synopsis, design decisions, IB and template.
Draft and check
Draft sections and review citations and cross-section checks.
Review in Word
Insert into Word and complete clinical and medical 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 study synopsis and design decisions
- Investigator’s brochure
- Schedule of activities
- Sponsor protocol template and amendment 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
Does it use the ICH M11 template?
It can follow the ICH M11 structure or your own protocol template. The structure is agreed at intake.
Can it draft protocol amendments?
Yes. Add the amendment instructions and current protocol; it drafts the changed sections and identifies related ICF and SAP updates.
Does it design the study?
No. It drafts from design decisions your team has made. Scientific and medical design choices stay with the study team.
Who reviews and approves the Clinical protocols?
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
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Draft master ICFs in plain language, grounded in the protocol.
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Statistical Analysis Plans
Draft SAP sections with complete estimands, before unblinding.
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Clinical Study Reports
Draft ICH E3 CSR sections where every number matches the tables.
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Talk to us about Clinical protocols
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