Automated Medical & Regulatory Document Generator
AutoMedWrite automatically generates high-quality, editable clinical, preclinical, regulatory and post-market documents — aligned with regulatory templates and traceability requirements — so your medical writing team can focus on strategy, not formatting.
Automate core regulatory documents across the clinical trial process
Clinical Documents
Clinical Study Report (CSR)
Clinical Trial Narrative (CTN)
Summary Clinical Safety (SCS)
Summary Clinical Efficacy (SCE)
Investigator’s Brochure (IB)
Informed Consent Form (ICF)
Post-Market & Vigilance Documents
Post-Market Surveillance Plan
PMCF Evaluation Report
Post-Market Clinical Follow-up (PMCF) Plan
Periodic Safety Update Report (PSUR)
– Class III
Summary of Safety and Clinical Performance (SSCP)
Regulatory / Clinical Evaluation & Safety Documents
Clinical Evaluation Plan (CEP)
Clinical Evaluation Report (CER)
Risk Management File (ISO 14971)
Literature Review Protocol & Report
Equivalence Justification Document
Preclinical / Non-Clinical Documents
Pharmacokinetic (PK) Report
Device-Specific / Technical Documentation
Instructions for Use (IFU) / Labeling
Technical Documentation (Annex II & III MDR)
Key Benefits
Save time
Generate first-complete drafts in minutes, not days.
Consistent quality
Standardized voice, sponsor-specific templates, and built-in style guides.
Traceability & audit trail
Every data point linked to source tables (TFLs), with version history and reviewer comments for inspections.
Seamless integrations
import from statistical outputs, EDC/CTMS exports, Excel/CSV and document management systems.
Editable, reviewer-ready output
Export to Word, PDF, eCTD-friendly formats; preserves headings, numbering and reference integrity.
Data privacy & security
Enterprise hosting, encryption in transit & at rest, and role-based access controls.
How it works
1
Connect & Upload
Upload your study datasets (tables/listings/figures), protocol, SAPs and any sponsor templates, or connect via secure integrations.
2
Auto-Generate Drafts
Select the document type (e.g., CSR, CER, PSUR). AutoMedWrite produces a fully structured draft that includes methods, results, safety narratives, and citations — formatted to your template.
3
Review, Edit & Export
Use the collaborative editor to review, annotate and approve. Export final documents to Word/PDF or eCTD-prepared packages with traceable source links.
Built for regulatory and clinical teams
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Medical writers: produce consistent drafts faster and reduce repetitive work.
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Regulatory affairs: prepare submission-ready technical files and dossiers.
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Safety & PV: auto-draft narratives, PSURs and PMCF reports with safety-data linking.
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R&D / Clinical ops: speed reporting and reduce time-to-publication.
Compliance & quality controls
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Templates and outputs are configurable to meet ISO 14971, MDR Annex II & III guidance and typical FDA/EMA expectations.
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Inline checks for missing references, inconsistent numbers, or unsupported claims.
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Full audit logs and electronic signatures to support inspection readiness.
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Option for on-premises deployment or private cloud for regulated data governance.
Clients Include
FAQs
How accurate are the generated drafts?
Drafts are generated from your data and templates. They are designed to be reviewer-ready but must be validated by domain experts — AutoMedWrite reduces drafting time and manual formatting; it does not replace scientific or clinical review.
Can I use my company template and style guide?
Yes — templates, glossaries, and style rules are fully configurable so output matches your sponsor formatting and preferred language.
Is protected health information safe?
Yes — we offer encryption in transit and at rest, role-based access, and can deploy on-premises for maximum data control.
What export formats are supported?
Microsoft Word (.docx), PDF, and export packages compatible with common eCTD and regulatory submission workflows.