Medical Writing

bioskin^® provides medical writing that is clear, comprehensive, carefully focused and precise.  The documents are standards-compliant and can be quickly and easily read and understood by scientific, medical and regulatory professionals.

Medical writing services are offered as stand-alone services and other therapeutic areas as well as part of full packages and include:

• Clinical Study Reports (CSRs) according to ICH-E3 for single- and multi-center trials
• Preparation of appendices for CSRs
• Linking and bookmarking processes
• CSRs in Common Technical Document (CTD) or electronic Common Technical Document (eCTD) for application dossier
• Research reports for non-drug studies, as well as abbreviated reports
• Study protocols, subject information leaflets
• Scientific publications (journal articles, abstracts, posters)
• Editing and review of documents assuring that documents comply with regulatory, journal, or other guidelines in terms of content, format and structure

All services can be offered according to bioskin^® or sponsor SOPs.