Yayınlarım

Organization of Clinical Trials (BA/BE and Phase 1)

  • BA/BE Study Design, Execution and Consultancy
  • BA/BE Pivotal/Pilot Studies
  • Preparation and Submittion of Ethics Committee and Ministry Application Dossiers
  • Selection of Clinical and Bioanalytical Centers
  • Clinical Monitoring
  • Organizion of Bioanalytical and Clinical Studies
  • Preparation of Statistical Reports and ICH E3-compliant Study Reports
  • Providing BA/BE Scientific Reporting Support to innovator companies
  • Organization of dissolution studies
  • In Vitro-In Vivo Correlation (IVIVC) evaluations
  • Biosimilar clinical studies
  • Medical device clinical studies