Service
Medical Writing
Clear, accurate scientific and regulatory documents, drafted from source and quality-controlled.
Overview
Clinical documents carry decisions. We draft them so that each statement is supported by a source, each table reconciles with the data and each section is written for the reader who will rely on it.
Our approach pairs scientific writing discipline with structured templates and a documented review cycle.
Standards & frameworks we work within
- ICH E3 (clinical study reports)
- ICH M4 (CTD)
- ICH E6 (GCP)
- CONSORT and ICMJE publication guidance
These are frameworks we work within or align to. They do not imply certification, accreditation or endorsement.
What we deliver
- Clinical study protocols and amendments
- Clinical study reports and synopses
- Investigator brochures and updates
- Patient narratives and safety summaries
- Informed consent form drafting support
- Publication and summary document support
Typical deliverables
- Draft and final documents
- Source-to-text QC records
- Comment resolution logs
- Style and template alignment
Engagement models
Project-based
A defined scope, timeline and set of deliverables agreed up front.
Dedicated capacity
Specialists embedded in your workflow on a longer-term, scalable basis.
Advisory & ad hoc
Targeted expert input, reviews or surge support when you need it.
Frequently asked questions
Service descriptions are general and informational. Scope, responsibilities and outputs are defined in a written agreement for each engagement.
Explore other services in the services overview.
Discuss medical writing
Tell us about your programme. We’ll respond with an honest view of how we can help, and where we can’t.