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CRO

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임상 Flow

Clinical trial Set-up

  • Site feasibility and Site pre-study visit(실시기관 적합도 평가 및 개시 전 방문)
  • Protocol and ICF Development (프로토콜 및 ICF 개발)
  • IND Follow-up and Communication with MFDS (식약처 임상시험 승인 및 소통)
  • Preparation of Dossier for IRB Submission IRB (서류 준비 및 제출)

  • 01

    Site feasibility

  • 02

    Site pre-study visit

  • 03

    IRB inital submission & approval

  • 04

    Site Contract

Clinical trial On-going

  • Communication with Sponsor (의뢰자 소통)
  • Management of Essential Documents (필수 문서 관리)
  • Investigator and Initiation Meeting (개시모임)
  • Monitoring and Management (모니터링 및 과제 관리)

  • 01

    Sponsor Kick off meeting

  • 02

    project Planning
    (PMP ,MP develop)

  • 03

    Project
    Scope/Time/Quality/Issue/Resource
    Management

  • 04

    Project closing

DM/STAT

  • Query Resolution and Data Quality Check (쿼리 해결 및 데이터 유효성 확인)
  • Consulting on statistical methodology and statistical epidemiology (통계 컨설팅)

  • 01

    DMP/DB Design
    (e-CRF / Paper CRF)

  • 02

    Data Validation / Medical Coding

  • 03

    Query Management

  • 04

    SAE Reconciliation

Clinical trial Close-out

  • Query Resolution and Data Quality Check (쿼리 해결 및 데이터 유효성 확인)
  • Statistical Analysis (통계적 분석)
  • SAE Reconciliation (중대한 이상반응 중재)
  • Clinical Study Report Writing (결과보고서 작성)