Regulatory Medical Documents
Bioforum offers premium medical writing services across all therapeutic areas and fields within biomedical sciences. All of our writing experts hold doctorates and have many years of writing experience. Documentation styles include study-specific 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 clinical study reports
• Patient narratives
Writing support for full product development programs
• Briefing packages for meetings with regulators
• Data safety update reports
• Investigator brochures
• Common Technical Document (CTD) summaries