Medical Writing

Medical Writing​​​

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

Training sessions
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

eCTD services

 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.

Introduction

Our Expertise

PhD-level education with over 10 years of experience

Wide range of therapeutics areas

Early and late phase product development

Clinical study protocol mini-webinar