I provide specialised medical writing services covering regulatory documentation, clinical research and patient-facing materials. My services include the preparation, development and review of scientific and regulatory documents, with a focus on accuracy, clarity and compliance with applicable requirements.
1. Regulatory & Clinical Trial Documentation
Preparation and development of clinical and regulatory documentation supporting clinical trial planning, conduct, reporting and regulatory submissions.
Document types:
- Clinical Study Protocol (CSP)
- 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)
2. Medical Device Documentation
Preparation and development of clinical and regulatory documentation for medical devices, supporting clinical investigations, clinical evaluation and the provision of information for users.
Document types:
- 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)
3. Patient-facing & Plain Language Documents
Development of clear, accessible and patient-friendly materials that communicate complex medical and clinical information in a way that is easy to understand, while maintaining scientific accuracy.
Document types:
- Informed Consent Form (ICF)
- Patient Information Sheet (PIS)
- Lay Summary
- Patient Cards
Looking for medical writing support?
Get in touch to discuss your project and documentation needs.