AI drafting and QC in Microsoft Word
Periodic Safety Update Report
A PSUR summarises a marketed medicine’s safety data at set intervals, and every count has to add up. PharmAssist drafts the sections and shows where every figure came from.
See PSUR 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 PSUR summarises a marketed medicine's safety data at set intervals, and every count has to add up. 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 draft a PSUR?
Yes, as a sourced draft for expert review. PharmAssist lays out the PSUR structure in Word, drafts sections from your interval and cumulative safety data, and cites each count to its table, so totals that do not add up are easy to spot. It flags missing inputs rather than filling them. Medical review and the benefit-risk conclusion stay with your team.
How this document gets written today
EU PSURs are due on the dates set by the EURD list, and a PSUSA can bring several marketing authorisation holders’ reports together. Missing a deadline or submitting inconsistent counts creates avoidable questions.
Writers reconcile interval and cumulative case counts, exposure, literature and signal information, often under time pressure and across several products.
What your team can work on
Structure follows the PBRER format of ICH E2C(R2) as applied in EU GVP Module VII, with your template.
PSUR section drafts
Draft exposure, summary tabulations, signal and risk evaluation sections in the PBRER format used for EU PSURs.
Count reconciliation
Interval and cumulative counts are cited to their tables so totals can be checked at a glance.
Completeness checks
Required subsections are checked against the template, and missing inputs are listed.
Chat over your safety data
Ask questions of the source files and see which file each answer used.
How it works for PSUR
Choose PSUR
Select Periodic Safety Update Report and the data lock point.
Add the data
Upload interval and cumulative safety outputs, exposure and the prior PSUR.
Draft and check
Draft sections and review citations and the Checks panel.
Finalise
Insert into Word and complete review in your process.
What it drafts from
Select the approved sources for the task. Data handling follows the deployment and model-service configuration agreed with your team.
- Interval and cumulative safety outputs
- Exposure estimates
- Signal and literature summaries
- Reference safety information
- Prior PSUR
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
Is a PSUR the same as a PBRER?
For EU submissions the PSUR uses the PBRER format. The content scope and regional annexes follow GVP Module VII and your template.
Can it handle several products?
Each report is drafted from its own sources. Teams that run many PSURs reuse templates and approved wording across products.
What if counts differ between tables?
Because every count is cited, a difference between two tables or sections is visible in the draft and the Checks panel, so a reviewer can resolve it.
Who reviews and approves the PSUR?
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 PSUR
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