Medical Writer
Specialised medical writing services for clinical research, pharmaceutical development and regulatory documentation.
Supporting CROs, pharmaceutical companies, clinical trial sponsors and researchers with clear, accurate and high-quality scientific documentation.
Areas of Expertise
Regulatory & Clinical Trial Documentation
- Clinical Study Protocol
- Protocol Synopsis
- Clinical Study Report (CSR)
- Investigator’s Brochure (IB)
- Development Safety Update Report (DSUR)
- Case Report Form (CRF)
- Statistical Analysis Plan (SAP)
- Standard Operating Procedures (SOPs)
- Clinical Trial Application (CTA)
Medical Device Documentation
- Clinical Investigation Plan (CIP)
- Clinical Investigation Report (CIR)
- Clinical Evaluation Plan (CEP)
- Clinical Evaluation Report (CER)
- Instructions for Use (IFU)
- Summary of Safety and Clinical Performance (SSCP)
Patient-facing & Plain Language Documents
- Informed Consent Form (ICF)
- Patient Information Sheet (PIS)
- Lay Summary
- Patient Cards
Who I Support
Medical writing support tailored to the needs of organisations and professionals involved in clinical research and pharmaceutical development.
- CROs
- Pharmaceutical & Biotechnology Companies
- Clinical Trial Sponsors
- Clinical Researchers & Investigators
- Medical Device Manufacturers