AI Document Editor for Medical Writers
Medical writers produce documents where patient safety depends on accuracy — clinical study reports, CERs, and regulatory submissions. Vespper gives medical writers AI assistance with the traceability and evidence rigor their work demands.
1. Clinical Document Standards
Medical writers must produce clinical documents conforming to international harmonized standards.
ICH Guidelines
- ICH E3 structure and content of clinical study reports (CSR)
- ICH E6(R2) Good Clinical Practice documentation requirements
- CONSORT guidelines for reporting randomized controlled trials
- PRISMA guidelines for systematic reviews and meta-analyses
- CSRs not following ICH E3 structure may be rejected by regulatory authorities during submission review
- Non-CONSORT/PRISMA compliant publications face journal rejection and credibility challenges
2. Regulatory Writing Requirements
Medical writers produce regulatory documents that must meet authority-specific structural and content requirements.
Regulatory Document Formats
- Common Technical Document (CTD) Module 2 summary writing requirements
- FDA briefing document preparation for advisory committee meetings
- EU MDR clinical evaluation report requirements per MEDDEV 2.7/1 Rev 4
- Investigator's Brochure (IB) content requirements per ICH E6
- CTD summaries must accurately reflect the full data package — inconsistencies trigger regulatory queries
- Briefing documents for FDA advisory committees directly influence approval decisions
3. Publication & Manuscript Standards
Medical publications must comply with ethical guidelines and journal-specific requirements.
Publication Ethics
- ICMJE recommendations for authorship, disclosure, and manuscript preparation
- GPP3 (Good Publication Practice) guidelines for industry-sponsored research
- Journal-specific author guidelines and formatting requirements
- Medical writing disclosure requirements including ghostwriting prohibitions
- ICMJE non-compliance can result in manuscript retraction and author sanctions
- Undisclosed industry sponsorship or ghostwriting triggers journal investigation and reputational damage
4. Scientific Communication Compliance
Medical writers must ensure compliance with clinical trial transparency and results reporting requirements.
Results Reporting Requirements
- FDAAA 801 clinical trial results reporting on ClinicalTrials.gov
- EU Clinical Trials Regulation results reporting requirements
- Plain language summary requirements for patient and public audiences
- Lay summary writing standards meeting regulatory readability requirements
- FDAAA 801 violations carry civil monetary penalties up to $10,000 per day per violation
- EU CTR requires results posting within 12 months of trial completion regardless of outcome
5. Quality & Process Standards
Medical writing must follow quality processes ensuring accuracy, consistency, and compliance.
Medical Writing Best Practices
- AMWA and EMWA best practice guidelines for medical writing
- Document QC checklists for clinical and regulatory documents
- Regulatory submission readiness review processes
- Style guide compliance (AMA Manual of Style for publications)
- QC process documentation provides an audit trail demonstrating due diligence in document preparation
- Submission readiness reviews catch compliance issues before they become regulatory findings
What happens when documentation falls short
- Clinical trial results reporting violations with civil monetary penalties
- Regulatory submission rejection from non-compliant document structure
- Journal retraction from guideline violations or undisclosed conflicts
- Patient safety implications from inaccurate clinical documentation
- Regulatory delays from incomplete or inconsistent clinical narratives
What this means for your team
How Vespper serves medical writers
Clinical data integration
Upload clinical study data, statistical outputs, literature reviews, and safety reports. Vespper connects your narrative to the underlying evidence.
Regulatory structure compliance
Generate documents following ICH E3 (CSR), MEDDEV 2.7/1 Rev 4 (CER), or other regulatory templates with proper section organization.
Citation and evidence traceability
Every clinical claim, statistical result, and safety finding in your document links to its source study or dataset.
Collaborative medical review
Share drafts with medical monitors and statisticians, review their input in diff view, and maintain a complete revision trail.
How medical writers use Vespper
Upload clinical evidence
Connect clinical study reports, statistical tables, literature databases, safety data, and regulatory guidance.
Draft regulatory documents
Generate CERs, CSRs, or regulatory submissions with clinical claims traced to source studies and datasets.
Medical review and finalize
Collaborate with medical monitors, verify clinical accuracy, review all changes, and export for regulatory submission.
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Draft clinical and regulatory documents with AI that traces every claim to evidence.
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