Dt&CRO
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Center
창조적 혁신과 도전으로 미래의 CRO를 꿈꿉니다.
서비스 항목
Study Set-up
- Protocol and ICF Development
- IND Follow-up and Communication with MFDS
- Database Set-up and eCRF Development
- Preparation of Dossier for IRB Submission
Study On-going
- Communication with Sponsor
- Management of Essential Documents
- Investigator and Initiation Meeting
- Routine Monitoring and Close-out Visit
Study Close-out
- Query Resolution and Data Quality Check
- Statistical Analysis
- SAE Reconciliation
- Clinical Study Report Writing
Service Scope
- Protocol Development
- IRB submission
- Site Contract
- Project Management
- Site Monitoring
- Data Management
- Statistics
- CSR writing