Medical Writing

Our Medical Writing department assists the pharmaceutical and medical services sector with the preparation and editing of all types of reports, including clinical reports, medical publications (abstracts, posters, etc.), protocols, journal articles or expert reports, applying different methods of reporting clinical trial results or procedures.

All processes involving clinical trial reporting are conducted according to the ICH:E3 guideline (Structure and Content of Clinical Study Reports), thus ensuring trustworthy and quality results for our clients.

Our medical writers are carefully selected for their competence and passion for the craft of writing, and have strong scientific backgrounds from a wide variety of therapeutic areas, as well as detailed knowledge of GCP and ICH guidelines, so they are highly qualified to rapidly produce high quality, evidence-based documents.

We provide:

• Clinical development plans
• Protocols
• Clinical study reports
• Clinical sections of common technical documents (CTDs)
• Clinical sections of new drug applications (NDAs)
• Abstracts, manuscripts, and journal articles
• Investigator brochures and annual updates
• Informed consent forms
• Advisory B
• Response to clinical hold orders
• Preclinical study reports, expert reports, and summaries
• Data safety monitoring board (DSMB) manuals
• Written and tabular summaries
• Medical and scientific literature reviews