Medical Writing and Electronic Publishing
Your product’s success depends on regulatory-compliant documentation that is well-structured, detailed and thoroughly accurate. You want skilled medical writers who are excellent team players able to respond to shifting timelines and changes in scope of work, typical of medical writing projects.
Accovion medical writers create documentation covering a broad range of therapeutic areas in close cooperation with our Regulatory Consulting and Biostatistics and Safety & Vigilance groups. Rigorous quality control standards ensure that your documents are accurate and easy to follow. Our medical writers can work independently or manage a team of writers and other professionals to produce low-, medium- or high-complexity documents for regulatory submissions and license maintenance.
Accovion electronic publishing specialists can further enhance your documentation through electronic compilation and hyperlinking using the most up-to-date, industry-preferred software. You’ll receive concise and easy-to-comprehend submission-ready documents that are fully compliant with regulatory technical specifications and guidelines.
Responsive, professional service
Your requirements are our first priority and we strive to provide a personally responsive, yet always professional working partnership. Whether a single document or a full electronic submission, Accovion delivers the quality documentation you need in a professional manner, on time and within your budget.
Whether working in the context of a full-service project or on a stand-alone project, the professional medical writers at Accovion combine their knowledge of medicine, science, and language to deliver precise documents for all stages of your product’s life cycle.
Expertise & Experience:
- Informed consent forms
- Clinical study reports
- Clinical summaries and overviews (CTDs, BLAs, NDAs)
- Investigator brochures
- Pediatric investigation plans
- Briefing documents for regulatory agencies
- Patient safety narratives
- Full prescribing information
- Clinical overview for renewal of marketing authorization
- Risk management plans
- Phase IV and NIS reports
- Investigational plans and study reports for medical devices
Electronic Publishing Expertise & Experiences:
- Clinical study reports
- Investigational study reports
- Stand-alone publishing of CRFs
- Submission documents (e.g. CTDs) and dossiers
- Integrated summaries of safety with linked programmed tables
- Critical evaluation of data
- Members of EMWA (European Medical Writers Association)
- Ongoing trainings (internal and external)
- Dynamic team, with Medical Writers from a wide range of backgrounds
- Close cross-cooperation between departments
- Out-of-the- box thinking
- Providing customizedsolutions to meet your needs, fast response and highest quality results
Cenita Ettl, Ph.D.
Head, Medical Writing and Electronic Publishing
+49 6196 7709-382