AI drafting and QC in Microsoft Word
Periodic Benefit-Risk Evaluation Report
Bring together everything learned about a medicine’s benefits and risks over the reporting period, with each count and date traced to the source data.
See PBRER 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 PBRER brings together everything learned about a medicine's benefits and risks over the reporting period. 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 PBRER?
Yes, for the sourced parts of the report. PharmAssist lays out the ICH E2C(R2) structure in Word and drafts sections such as exposure, summary tabulations, signal and risk evaluation summaries from your period data, with a citation for every figure. The integrated benefit-risk analysis stays a reviewer-controlled narrative that your safety physician writes or approves.
How this document gets written today
A PBRER covers a marketed product’s worldwide experience: exposure, cumulative and interval safety data, signals, risk evaluation and the benefit-risk balance. Data come from safety databases, sales estimates, clinical programmes and literature.
The report has to be internally consistent across many sections and consistent with the previous report and the reference safety information. Reconciling all of it is where the time goes.
What your team can work on
Structure follows ICH E2C(R2) and applicable regional requirements, with your sponsor template.
E2C(R2) section drafts
Draft sections such as estimated exposure and use patterns, summary tabulations, signal overview and evaluation of risks from your period data.
Source and period reconciliation
Figures are drawn from the cited tables, so differences between sections or against the data lock point stand out.
Special population coverage
Completeness checks show whether required subsections, such as special populations, are covered by the sources.
Reviewer-controlled benefit-risk
Evaluation and conclusions stay with the safety physician; drafts supply the sourced supporting text.
How it works for PBRER
Choose PBRER
Select Periodic Benefit-Risk Evaluation Report and the reporting interval.
Add sources
Upload exposure, safety outputs, benefit evaluations, the RSI and the prior report.
Draft and reconcile
Draft sections and check citations and figures across the report.
Review and finalise
Insert into Word and complete review, sign-off and submission 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.
- Exposure and patient-use estimates
- Cumulative and interval safety outputs
- Signal and risk evaluations
- Reference safety information
- Prior PBRER
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
What is the difference between a PBRER and a PSUR?
In the EU, the PSUR follows the PBRER format described in ICH E2C(R2) and GVP Module VII. PharmAssist supports both; see the PSUR page for EU-specific detail.
Can it carry content from the previous report?
Yes. Add the prior PBRER as a source and the draft can reuse unchanged content with a citation, while new period data come from the current tables.
Does it make benefit-risk conclusions?
No. It drafts sourced supporting text. Conclusions are written or approved by your safety physician.
Who reviews and approves the PBRER?
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 PBRER
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