AI drafting and QC in Microsoft Word
Statistical Analysis Plans
A statistical analysis plan fixes how every endpoint will be analysed, before the data are unblinded. PharmAssist drafts it from approved decisions and checks the estimands.
See Statistical Analysis Plans 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 statistical analysis plan fixes how every endpoint will be analysed, before the data are unblinded. 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 statistical analysis plan?
Yes, for the documentation work. PharmAssist drafts SAP sections from your protocol and the analysis decisions your statisticians have made, and checks that each estimand states its five ICH E9(R1) attributes. It cites the protocol or decision record behind each statement. Statisticians own every analysis choice.
How this document gets written today
SAPs translate the protocol’s objectives and endpoints into precise analysis specifications: populations, estimands, handling of intercurrent events and missing data, and multiplicity.
Inconsistencies between the SAP and the protocol, or incomplete estimands, are among the most common review comments.
What your team can work on
ICH E9 and E9(R1) principles and your sponsor SAP template.
SAP section drafts
Draft analysis populations, endpoints, estimands and methods sections from approved decisions.
Estimand completeness
Check that each estimand states treatment, population, variable, intercurrent event strategy and population-level summary.
Protocol consistency
Citations show where each statement agrees with the protocol.
Change tracking support
Redraft affected sections when the protocol is amended.
How it works for Statistical Analysis Plans
Choose SAP
Select Statistical Analysis Plan and the study.
Add sources
Upload the protocol and analysis decision records.
Draft and check
Draft and review estimand and consistency checks.
Review
Insert into Word for statistical review and sign-off.
What it drafts from
Select the approved sources for the task. Data handling follows the deployment and model-service configuration agreed with your team.
- Protocol
- Approved estimands and analysis decisions
- Analysis populations
- Missing-data and multiplicity strategies
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 choose the statistical methods?
No. It documents the methods your statisticians have chosen and checks that the documentation is complete and consistent.
What does the estimand check cover?
It checks that each estimand states the five attributes described in ICH E9(R1).
Can it draft the statistical analysis report?
Report sections can be drafted from approved outputs in the same way, with citations.
Who reviews and approves the Statistical Analysis Plans?
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 Trial Protocols
Draft protocol sections from the approved synopsis and design decisions.
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Clinical trial documents
Clinical Study Reports
Draft ICH E3 CSR sections where every number matches the tables.
Read more
Real-world evidence
Real-World Evidence Protocols and Reports
Draft non-interventional study protocols and reports.
Read more
Talk to us about Statistical Analysis Plans
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