AI drafting and QC in Microsoft Word
Nonclinical Overviews and Study Documents
A nonclinical overview brings the animal and laboratory findings together for the regulator. PharmAssist drafts it from the study reports and cites every study.
See Nonclinical documents 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.
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A nonclinical overview brings the animal and laboratory findings together for the regulator. 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 help write a nonclinical overview?
Yes, as a sourced draft. PharmAssist drafts Module 2.4 overview and 2.6 summary sections, such as pharmacokinetics, from your nonclinical study reports, citing the study behind each finding. It flags study details that are missing, such as GLP status, species, dose or duration. Toxicologists and pharmacologists own the interpretation.
How this document gets written today
Nonclinical writers summarise pharmacology, pharmacokinetics and toxicology studies into the CTD overview and summaries, and write study protocols for new GLP studies.
Study tables need complete details for every study, and the overview must reflect the reports exactly.
What your team can work on
CTD Module 2.4 and 2.6 structure, GLP study-plan requirements and your sponsor conventions.
Overview and summary drafts
Draft Module 2.4 and 2.6 sections, such as 2.4.3 Pharmacokinetics, from study reports.
Study-level citations
Each finding cites the study it came from.
Missing study detail flags
GLP status, test system, dose, group size or duration missing from a source are flagged.
Study protocols
Draft nonclinical study protocol sections from the approved design.
How it works for Nonclinical documents
Choose nonclinical
Select the overview, summary or study protocol.
Add study reports
Upload the study reports and data.
Draft and check
Draft and review citations and missing details.
Review
Insert into Word for scientific 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.
- Nonclinical study reports
- Pharmacology, pharmacokinetic and toxicology data
- Approved study design and test-article information
- Sponsor templates
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
Which nonclinical sections can it draft?
Overview and summary sections your study reports support, and nonclinical study protocols. Scope is agreed at intake.
Does it interpret toxicology findings?
It drafts from the reports and conclusions you supply. Interpretation stays with your toxicologists.
What does it flag in study tables?
Missing GLP status, test system, dose or concentration, group size and duration for each study.
Who reviews and approves the Nonclinical documents?
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.
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Talk to us about Nonclinical documents
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