Scientific Ideas. Professional Presentation.
Medical writing and the preparation of research-relevant documents must meet regulatory and clinical requirements. We ensure full compliance with all requirements through diligent planning of studies, accurate reporting, a well-documented approval process as well as constant monitoring and review.
All facts must be depicted and presented in a precise, clear and comprehensive manner. With our know-how and dedicated resources, our team will prepare all study-specific documents and presentations. Our customers decide either to benefit from individual services included in our range of services or from our complete medical writing service. We work closely with our customers and study-specific needs into account for continuously providing transparent information needed by customers to monitor the status of work.
Our Services in Medical Writing
- All medical/scientific information from literature
- Test plans
- Documentation sheets (CRFs)
- Standard operating procedures (SOPs)
- Clinical study reports and amendments
- Expert reports
- Meta-analyses reports
- Safety reports
- Documents to be submitted to government agencies and ethics committees
- Clinical summaries and overviews for worldwide regulatory submissions (MAA, NDA, BLA in CTD and eCTD format)
- Briefing documents for regulatory agencies
- Responses to questions from regulatory authorities