Clinical study reports are produced by the medical writer, in collaboration with the medical team and the project statistician, ensuring a complete and accurate representation of all aspects of the study and its results, while respecting tight timelines.
The integrated clinical reports are prepared according to ICH E3 guidelines and format, or according to the sponsor’s specific format. The final documents can be published compliant to the requirements for an eCTD submission.
Support is provided for preparing abstracts, posters and manuscripts.
The Medical Writing Services offered at CBS are
Clinical Trial Related Writing:
- Clinical Trial Protocols
- Clinical Study Reports
- Regulatory Documents (DSUR, PSUR, CTD, etc.)
- Regulatory meeting briefing packages
- Clinical study reports (Phase I, II, III, and IV)
- Clinical sections of new drug applications (NDAs)
- Investigator brochures
- Informed consent forms
- Manuscript and Brochure Writing
- Abstract Drafting
- Scientific Poster Boards
- Scientific PowerPoint Presentations