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Smarter Development
& Focus on
Execution.

Ensuring the delivery of
high quality services through
diligent planning and unmatched
clinical experience

 

MEDICAL WRITING

Our medical writing team draws on extensive industry knowledge and oncology therapeutic expertise to effectively meet our clients' needs. Our writers consult with therapeutic experts, researchers and academics to help them develop a sophisticated and in-depth understanding of your program. Their experience and training enable them to expertly prepare reports in accordance with ICH human use guidelines. They create clinical trial and regulatory documentation suitable for submission to the FDA and other regulatory agencies. Our vast experience helps us deliver a portfolio of medical writing services to address the needs of every clinical research project, including:

  • Drug development plans
  • Investigator brochures
  • Protocols synopses, full protocols, and protocol amendments
  • Informed Consent Form (ICF)
  • Clinical study reports (Phase I, II, III, and IV)
  • Interim data summaries
  • FDA Pre-IND Meeting Packages
  • Investigational New Drug Application (IND)
  • Common Technical Document (CTD) sections
  • Abstracts and manuscripts