AI drafting and QC in Microsoft Word
Patient Safety Narratives
A patient narrative tells the story of one serious event, and every date and dose has to be right. PharmAssist drafts it from the case data and shows the source of each fact.
See Patient narratives 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 patient narrative tells the story of one serious event, and every date and dose has to be right. 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 patient safety narratives for a CSR?
Yes, as a sourced draft. PharmAssist drafts each narrative from the participant’s case data, adverse event, dosing, laboratory and concomitant medication listings, in your narrative template, and cites the source for each date and value. Missing data are flagged instead of guessed. Medical review stays with your team.
How this document gets written today
ICH E3 asks for narratives of deaths, other serious adverse events and other significant adverse events. Large studies can need hundreds of them.
Each narrative is assembled from several listings: demographics, dosing, event onset and outcome, labs, concomitant medications. Transcription errors in dates and doses are the most common QC finding.
What your team can work on
Narratives as described in ICH E3 section 12.3.2, in your sponsor template.
Template-based narratives
Draft each narrative in your template: background, event, treatment, outcome and causality as recorded.
Fact-level citations
Each date, dose and value cites the listing it came from.
Missing data flags
Gaps in the case data are listed instead of filled.
Consistent style at volume
The same structure and wording conventions across every narrative.
How it works for Patient narratives
Choose narrative
Select Patient Narrative and the participant.
Add case data
Upload the case data and listings for that participant.
Draft and check
Draft and review citations and missing data flags.
Review
Insert into Word and complete 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.
- Participant case data
- Adverse event and dosing listings
- Laboratory and concomitant medication listings
- Narrative template
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 events need narratives?
That is your team’s decision, typically deaths, other serious adverse events and other significant adverse events, as described in ICH E3.
Does it assess causality?
No. It reports the investigator’s and sponsor’s assessments as recorded in the source. Medical judgement stays with your team.
Can it draft narratives for a DSUR or PSUR?
Narratives can be drafted for any report your team needs, from the same case data, in the template for that report.
Who reviews and approves the Patient narratives?
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
Clinical Study Reports
Draft ICH E3 CSR sections where every number matches the tables.
Read more
Safety and periodic reports
Development Safety Update Report
Draft ICH E2F DSUR sections from your reporting-period safety data.
Read more
Safety and periodic reports
Periodic Safety Update Report
Draft EU PSUR sections where every count has to add up.
Read more
Talk to us about Patient narratives
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