Novella Clinical understands the importance of medical writing — from protocol to package insert — and our goal is to produce concise, substantive and polished clinical documents.

Our medical writers have the skills and relevant medical/scientific education to produce expertly written documents. Working closely with our project teams, Novella’s medical writers ensure accuracy and consistency.

Using a flexible approach, we offer medical writing as a component of a full-service program or as a stand-alone service. We maintain a library of ICH templates for regulatory submissions, but we can also use customer templates and follow customer style guides upon request.

Our medical writing services include:

 

  • Clinical study reports
  • Protocols
  • FDA briefing documents
  • Clinical and summary sections of Common Technical Documents (CTDs)
  • Clinical and summary sections of New Drug Applications (NDAs)
  • Investigational New Drug Applications (INDs) and Annual Updates
  • Investigator’s brochures
  • Biologic License Applications (BLAs)
  • Informed consent forms
  • Abstracts, posters and journal articles
  • Executive summaries for efficacy or safety
  • Patient narratives
  • Package inserts