Medical Writing
Professional creation of medical and scientific documentation at the highest level.
Clinical protocols and relevant study materials
- Protocol development:
Complete protocol writing, study design, methodology, statistical considerations, and regulatory compliance - Investigator materials:
Investigator’s Brochure (IB), training manuals, and reference guides - Patient documentation:
Informed consent forms, patient information sheets, and educational materials - Regulatory documents:
Study-specific procedures, monitoring plans, and compliance documentation - Amendment writing:
Protocol modifications, clarifications, and regulatory update documents
- Protocol development:
Clinical Study Reports (CSR)
- Comprehensive CSR preparation:
ICH E3 compliant reports for regulatory submissions - Statistical sections:
Analysis methodology, results presentation, and data interpretation - Safety reporting:
Adverse event summaries, safety analyses, and risk-benefit assessment - Efficacy documentation:
Primary/secondary endpoint analysis and clinical conclusions - Regulatory formatting:
Submission-ready documents for EMA, FDA, and national authorities - Quality review:
Medical accuracy, consistency checks, and regulatory compliance verification
- Comprehensive CSR preparation:
