Medical Writing

Communication is key. On average, our writers have more than a decade of medical writing and clinical trial expertise, with nearly two decades of experience for our senior staff.

Team members are medical, scientific, biostatistical, epidemiological, and regulatory specialists with diverse technical backgrounds and an array of skill sets, including exceptional project management capabilities.

These attributes allow us to take on and guarantee high-quality, on-time delivery of a wide range of therapeutic and content-specific writing projects at all stages of clinical development.

Regulatory and Clinical Writing

Providing fundamental insights and contributions at all phases of clinical development

• Strategic therapeutic- and indication-specific collaboration from study concept and design to final study report and submission
• Active and routine engagement and consultation with statistical, medical, and scientific experts
• Rigorous processes for quality, accuracy and accountability that assure compliance with current regulatory standards and on-time delivery
• International Council for Harmonisation (ICH)-compliant templates and ability to use sponsor-specific templates, style guides or standard-operating procedures
• Expertise integrated as a component of full-service contracts or as stand-alone projects adapted to client needs

Offering:

• Protocol development and oversight throughout the life of the study
• Clinical Study Reports (CSRs)
• Investigator Brochures (IBs)
• Safety narratives and reports
• Informed Consent Forms (ICFs)
• Study charters
• Clinical and nonclinical summaries
• Summary clinical development plans
• Material preparation for advisory board meetings