Bioforum offers medical writing services in a wide range of therapeutics areas performed by experienced medical writers with PhD level degrees in life science and over 10 years of experience. These include study-specific documents and development-program documents. The medical writing service is fully integrated into multi-disciplinary clinical development teams, specifically safety, biostatistics and data management aimed at producing the highest-quality, most regulation-compliant, clear and informative documents while adhering to timelines.
Writing support for clinical studies
• Clinical study protocols and Reports
• Patient narratives
• Medical Communications (articles, text for presentations and posters)
QC support for clinical documents
Writing support for full product development programs
• Briefing packages for meetings with regulators
• Data safety update reports
• Investigator brochures
• Clinical CTD documents
Our medical writers offer training sessions tailored to customer needs, on various writing-related topics. Examples include:
• A full day training program for physician-researchers
• A full day course on regulatory clinical documents
• A half-day session on protocol development
• Create and edit eCTD documents according to ICH and national regulatory authority guidelines.
• Manage documents and eCTD sequence lifecycles on a dedicated Document Management System in accordance with regulatory requirements.
• Create and publish eCTD sequences on a dedicated eCTD compilation system in accordance with regulatory requirements.
• Validate eCTD sequences using specialized validation tools in accordance with ICH and national regulatory authority validation criteria.
• Submit eCTD sequences to regulatory agencies.
PhD-level education with over 10 years of experience
Wide range of therapeutics areas
Early and late phase product development