Novella Clinical’s medical writing staff plays a vital role in the product-lifecycle model with our customers. Our writers possess the skills and relevant medical/scientific education to produce expertly written documents, and they are integrated with our project teams to ensure accuracy and consistency.

Our expertise includes indication for use statements, product label claims, interim analysis and periodic safety reports, annual IDE updates and final CSR compilations for both sponsors and regulatory agencies. Additionally, for post-market support, we offer medical writing for medical journals, abstracts, registry protocols and CSRs.

Using a flexible approach, Novella offers 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 client templates and follow client style guides upon request.

Our medical writing services include:

 

  • Preclinical and Clinical Study Protocols
  • Clinical study reports
  • FDA briefing documents
  • Clinical and summary sections of Common Technical Documents (CTDs)
  • Clinical and summary sections of Premarket Approvals (PMAs), 510(k)s, etc.
  • Abstracts, posters and journal articles
  • Investigator’s brochures
  • Informed consent forms
  • Executive summaries for efficacy or safety
  • Patient narratives
  • Instructions for use (IFU)
  • Clinical evaluation reports