Specialized GI Medical Writing
Our medical writers understand the nuances of GI endpoints and work in close collaboration with biostatistics, clinical data management, and medical monitoring to ensure every document matches the analytical reality of the study:
- Coordination: We verify that statistical sections in protocols and reports match perfectly with the analysis plan
- Operational reality: We ensure that schedule of assessments and procedure descriptions match how the study is run at the site level
GI Medical Writing Services
We support your program from concept to publication so every document in the trial life cycle is clear and consistent:
Planning & design
Concept protocols, protocol synopses, full protocols, and amendments
Regulatory & clinical writing for submissions
Investigator’s brochures (IB), IND/CTA content, briefing packages for agency meetings, and responses to regulatory questions
Safety reporting
Development safety update reports (DSURs) and safety narratives
Results & publications
Clinical study reports (CSRs) compliant with ICH E3, summaries for participants, and layout-ready appendices:
- Abstracts
- Posters
- Manuscripts for peer-reviewed journals
Quality and Compliance
Our medical writing services start with a data-driven outline and rigorous quality control process to ensure accuracy and audit readiness:
Source verification
All tables, figures, and listings (TFLs) are checked against source data to ensure absolute accuracy
Regulatory standards
Templates follow ICH E3 and regional guidance
Audit readiness
Versions are controlled in the eTMF with full audit trails
