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 for dermatological and other therapeutic areas as well as part of full packages and include:
- Clinical trial protocols, clinical investigation plans
- Subject information leaflets, diaries
- 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
- Clinical investigation reports (CIRs) according to ISO 14155
- Lay language summaries
- 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
- Regulatory documentation (IND, briefing packages, etc.)
All services can be offered according to bioskin or sponsor SOPs.