We write clear, accurate and regulation-compliant documents, and deliver them on time.
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
Clinical Writer- Study Protocols
Our experienced team of medical writers supports clinical development teams in creating clinical study protocols. As soon as the design has been decided, the medical writer develops it into a full, submission-ready and ICH E6-compliant document. The Bioforum medical writer becomes a part of the clinical development team, taking care to receive input from all relevant study stakeholders. We keep a flexible and agile approach, assisting teams in creating protocols that reflect the most up-to-date decisions in the complex process of study design.
Clinical Reports and Summaries
Bioforum writers have vast experience in writing clinical study reports and CTD summaries in a wide array of therapeutic areas. We write reports that are ICH E3-compliant (or ISO 14155 for medical device, as applicable) for studies from Phase I (including clinical pharmacology studies), through Phase II and III (clinical efficacy and safety) to Phase IV (including safety registry and post-marketing observational studies). We have experience in writing the Module 2.7.1 Summary of Biopharmaceutic Studies, Module 2.7.2 Summary of Clinical Pharmacology, Module 2.7.3 Summary of Clinical Efficacy and Module 2.7.4 Summary of Clinical Safety, as well as reports of integrated analyses (Module 22.214.171.124 Integrated Summary of Efficacy and Integrated Summary of Safety) and clinical overviews. We work in collaboration with the clinical, regulatory and statistical experts to develop the most accurate and clear reports and summaries, paying meticulous attention to detail while taking care to provide the reader with a holistic understanding of results.
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