AI drafting and QC in Microsoft Word
Clinical Study Reports
A clinical study report runs to hundreds of pages, and every number has to match the tables. PharmAssist drafts sections from your approved outputs and cites each figure.
See Clinical study reports 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 study report runs to hundreds of pages, and every number has to match the tables. PharmAssist works inside Word. Choose the document type and add your source files. Open the report you are already writing. PharmAssist works with the sections already in it. 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 study report?
AI can draft CSR sections for expert review. PharmAssist drafts methods, disposition, protocol deviations, efficacy and safety sections in the ICH E3 structure from your protocol, SAP and approved TFLs, and cites the table behind every number. It flags values it cannot find, so the medical writer reviews a traceable draft. Interpretation stays with the study team.
How this document gets written today
CSR writing pulls together the protocol, SAP, tables, figures and listings, and study-conduct records into a long ICH E3 report. Writers spend most of their time transcribing and cross-checking numbers.
Quality control then checks every number against the TFLs again. Any mismatch, between the synopsis and the body or between text and table, becomes a finding.
What your team can work on
Structure follows ICH E3; body and appendix scope agreed for each engagement.
E3 section drafts
Draft sections such as 9 Investigational plan, 10.1 Disposition, 10.2 Protocol deviations, 11 Efficacy and 12 Safety evaluation from approved outputs.
Number-to-table citations
Each value cites the table, figure or listing it comes from.
Citation and gap checks
Passages without a source citation and values missing from the sources are flagged for the reviewer.
Synopsis consistency
Check that the synopsis matches the body sections it summarises.
How it works for Clinical study reports
Choose CSR
Select Clinical Study Report and confirm the study ID.
Add outputs
Upload the protocol, SAP, TFLs and conduct records; confirm the sources.
Draft and check
Draft sections and review citations and checks.
Review in Word
Insert into the CSR and complete QC 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.
- Final protocol and amendments
- Statistical Analysis Plan
- Approved tables, figures and listings
- Disposition, deviation and study-conduct records
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 follow ICH E3?
Yes. The outline follows ICH E3 and your template. Body and appendix scope are agreed for each engagement.
Can it draft patient narratives?
Yes. Narratives for deaths, serious and other significant adverse events have their own workflow. See the patient narratives page.
How does it handle numbers?
Every number is cited to a table, figure or listing. Values that cannot be found are flagged rather than filled in.
Who reviews and approves the Clinical study reports?
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
Patient Safety Narratives
Draft patient narratives where every date and dose has to be right.
Read more
Biostatistics
Statistical Analysis Plans
Draft SAP sections with complete estimands, before unblinding.
Read more
Scientific communications
Plain Language Summaries
Tell patients and the public what a study found, simply.
Read more
Talk to us about Clinical study reports
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