- Angiology
- Interventional Cardiology
- Neurology
- Participation in meetings with sponsor and investigational site
- Creating of study specific documents ( CRF, protocol)
- Teaching of study staff according GCP
- Investigator site Initiation visit
Project-related monitoring
of Clinical Trials mainly
medical devices in
The monitoring is project-based, in cooperation with international and national capacity CRO's to ICH-GCP standards and to the European standard for clinical investigation of medical devices EN ISO 14155th .
Planning and Preparation
- Regular monitoring visits
- Protocol and Product Support
- Continuing quality control of data collection
- Individual monitoring reports
- Conducting of Trial Master File
- Close-Out visit of investigator’s site
- Checking of document completeness