서비스
Clinical Research
SDV(Source Data Verification)을 넘어 Site Management를 추구합니다.
업무범위
- Project Planning
- Project Management
- Investigator’s Meeting
- Site feasibility & Site selection
- IRB Process(Initial, amendment, closing, annual reporting etc)
- Site Contract
- Site Initiation
- Site monitoring & Source document verification
- Site close-out
- Site management(recruit, training, issue management)
- Adverse events & SAE reporting
- Audit / Inspection Preparation & correspondence