Thanks to a full portfolio of medical writing services, our clients have access to start-to-finish support for every clinical research text, including expertly crafted reports in compliance with ICH human use guidelines, clinical trial protocols, regulatory documentation, and other submission documents all the way to abstract and manuscript completion. Our oncology medical writers consult with your team—as well as therapeutic experts, researchers and academics—to develop a sophisticated and in-depth understanding of your program. Writing services vary by your needs and can include:

  • Drug development plans
  • Investigator brochures
  • Protocol synopses, full protocols and protocol amendments
  • Informed Consent Form (ICF)
  • Clinical study reports (Phase I and II)
  • Interim data summaries
  • FDA pre-IND meeting request and briefing packages
  • Investigational new drug application (IND) (technical writing for all IND Modules 1-5)
  • Abstracts and manuscripts

Ask us how you can get your clinical plan started today.