Draft PLR-format prescribing information from your CCDS and approved sources.
PharmAssist by GenText
See PharmAssist work in Word.
One-minute narrated demos of PharmAssist drafting regulated documents in Microsoft Word, on a fictitious study and product. Each one shows the same flow: choose the document type, add your sources, review the outline, draft a section with citations, check it, insert it, and ask questions of your own files in chat. Pick the document your team owns, or request a live demo and we will walk through your workflow with you.
Read the transcript
A development safety update report pulls serious adverse event data from across your clinical trials, every year. 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.
Demos by document
Choose the document your team owns.
Each demo shows one document family. The live demo covers the same workflow with your questions, your review process and your next milestone in mind.
Regulatory labelling
EU Summary of Product Characteristics
Draft QRD-structured SmPC sections from your core data sheet.
Draft patient leaflet sections in plain language from the approved SmPC.
Adapt core labelling to one country’s rules and approved wording.
Safety and periodic reports
Development Safety Update Report
Draft ICH E2F DSUR sections from your reporting-period safety data.
Periodic Benefit-Risk Evaluation Report
Draft ICH E2C(R2) PBRER sections from cumulative and interval data.
Draft EU PSUR sections where every count has to add up.
Draft REMS documents and materials that match the label and safety data.
Clinical trial documents
Draft protocol sections from the approved synopsis and design decisions.
Draft master ICFs in plain language, grounded in the protocol.
Country and Site Informed Consent Forms
Adapt the master ICF to one country’s requirements.
Draft ICH E3 CSR sections where every number matches the tables.
Draft patient narratives where every date and dose has to be right.
Medical information
Draft standard and custom responses from approved evidence.
Scientific communications
Publications and Congress Abstracts
Draft abstracts and manuscripts from approved study outputs.
Tell patients and the public what a study found, simply.
Real-world evidence
Real-World Evidence Protocols and Reports
Draft non-interventional study protocols and reports.
Biostatistics
Draft SAP sections with complete estimands, before unblinding.
Nonclinical
Nonclinical Overviews and Study Documents
Bring animal and laboratory findings together for the regulator.
Regulatory CMC and quality
Demo coming soon
Request a live demoCMC Module 3 and Quality Overall Summary
Draft CTD Module 3 sections and the Quality Overall Summary from quality sources.
Prefer to see it live?
Tell us your role and the document you want to see. Alex Charles will reply within one business day and propose a time for a working demo.
Prefer email? alex@gentext.ai