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