AI drafting and QC in Microsoft Word
Real-World Evidence Protocols and Reports
A real-world evidence protocol sets out the data source, the design and the analysis before the study starts. PharmAssist drafts it from the decisions your team has made.
See RWE protocols & 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 real-world evidence protocol sets out the data source, the design and the analysis before the study starts. 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 real-world evidence study protocol?
Yes, as a sourced draft for the study team. PharmAssist drafts the RWE protocol from your approved research question, design, data-source description and analysis plan, cites the source for each statement and checks that the methods match the question. Epidemiologists and the study team own the design and interpretation.
How this document gets written today
RWE and non-interventional studies, including post-authorisation safety studies, need protocols that justify the data source, define exposures and outcomes, and pre-specify analyses.
Keeping the research question, methods and later report consistent is what regulators and reviewers look for first.
What your team can work on
Applicable non-interventional study guidance, such as GVP Module VIII for PASS, and your sponsor templates.
RWE protocol drafts
Draft research question, design, data source, variables and analysis sections.
Study report sections
Draft results sections from approved analysis outputs.
Question-to-methods consistency
Check that exposures, outcomes and analyses match the stated question.
Citations
Every statement cites the design document or output it came from.
How it works for RWE protocols & reports
Choose RWE protocol
Select Non-Interventional Study Protocol or Report.
Add sources
Upload the research question, design, data-source description and analysis plan.
Draft and check
Draft and review citations and checks.
Review
Insert into Word for study team 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.
- Approved research question and design
- Data-source description
- Analysis plan
- Approved analysis outputs
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
Can it draft PASS protocols?
Yes, in your template and with the sources you supply. Your team confirms what the applicable guidance requires.
Does it choose the data source?
No. It drafts from the data-source decisions and descriptions your team has approved.
Can it draft the final study report?
Yes. Report sections are drafted from approved analysis outputs with citations.
Who reviews and approves the RWE protocols & 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.
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Talk to us about RWE protocols & 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