Personal profile
Job responsibilities
I advise public researchers conducting clinical drug trials or medical device investigations on the design of trial documents and submissions to authorities. I monitor trials before, during, and after data collection, and my work is based on the international guidelines for Good Clinical Practice (ICH-GCP) and the guideline for Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155).
Areas of expertise
- GCP
- Clinical drug trial
- Monitoring
- Investigation of medical device