I am a freelance expert on Clinical Trial Applications and Quality Control.

I am specialized in:

  • CTA submissions to Ethics Committees
  • CTA submissions/notifications to Competent Authorities
  • Compilation/modifications of Patient Information and Consent Forms
  • QC of Trial Master File and Clinical Study Report

Over 14 years of experience in the pharmaceutical industry compiling and coordinating Clinical Trial Applications in various indications combined with long term cooperation with the Competent Authorities and Ethics Committees provide a firm ground for quality and reliable submissions on schedule.