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