Interventional & Non-interventional

Study set up

  • Study design according to EMA, FDA & ICH guidelines, literature and assessment reports
  • Protocol, CRF & ICF development
  • Dossier compilation and submission to RA, EC & IRBs for study approval

Study conduct

  • Clinical site selection, patient recruitment, monitoring, site management

Data management & Statistical analysis

Clinical Investigation Report

  • Report according to ISO 14155:2011

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