Medical Writing

Medical_Writing_BiometricsCROS NT has an expert panel of Medical Writers with decades of experience between them in both Europe and North America. All of our Medical Writers are native or fluent English speakers, and some have bilingual writing capabilities. These Medical Writers have produced technical and scientific documentation for all phases of clinical trials (I-III) as well as post-market studies for both the EMA and FDA.

We can write your:

  • Protocol
  • Common Technical Document (CTD/eCTD)
  • Clinical Study Reports (CSR)
  • Investigational Medicinal Product Dossier (IMPD)
  • Investigational New Drug Application (INDs)
  • Investigator Brochure
  • EMA and FDA Briefing Package
  • Statistical Analysis Plan (SAP)
  • PSUR/DSUR
  • Marketing Documentation (MAA and NDA)
  • Integrated Summaries of Safety and Efficacy (ISS/ISE)
  • Paediatric Investigational Plans (PIP)
  • Poster and/or Abstract