Phase I to IV clinical trials in compliance with ICH/GCP guidelines and local regulations :
- Feasibility studies
- Site selection and study start up
- Ethics Committee submission, file preparation and tracking procedures
- Investigator selection and training
- Site management (pre-study site visits, initiation, monitoring and close-out)
- Serious Adverse Event (SAE) form checking and reporting
- ICH/ GCP training
- Biological sample logistics