Medical writing and the preparation of research-relevant documents must meet regulatory and clinical requirements. We ensure this 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 comprehensive resources, our team will prepare all study-specific documents and presentations for you. You can either take advantage of individual services included in our range of services or our complete medical writing service. We will work closely with you, taking company and study-specific needs into account, and we will always keep you up-to-date.
We support you with the preparation of:
• All medical/scientific information from literature
• Test plans
• Documentation sheets (CRFs)
• Standard operating procedures (SOPs)
• Clinical study reports and amendments
• Expert reports
• Safety reports
• Interim reports, final report writing
• 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
we are regularly seeking data managers, statistical programmers, biometricians/statisticians and medical writers