지디에프아이 브레인셀연구소

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  • GDFI Braincell Laboratory

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  • GDFI Braincell Laboratory

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  • GDFI Braincell Laboratory

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    最

Service + Clinical Trial

임상시험, 규제기관의 인허가, 임상전자데이터관리(IT/DM), 통계분석,CSR,QA 등

임상시험, 규제기관의 인허가,
임상전자데이터관리(IT/DM), 통계분석,CSR,QA 등

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  • Clinical Operations
    - Selection of Medical Institution and Investigations
    - Site Management
    - Monitoring (PMP, SIV, IMV, COV)
    - Safety Management (SAE, AE)
    - Study Documentation (TMF, ISF, PF)
    - IP management (Local, Global)
    - Holding · Various · Conferences
    Project Management
    - Overall Project Management (Alliance, Risk, Time, Status, Quality and Budget)
    - Responsibility for cross-functional activities
    - Main task in the resolution of conflict
    - Regular meetings(issue focused proposals and CAPA implementation)
    - Distributor work progression report
    - Vender Management
    Regulatory Affairs
    - Planning of pharmaceuticals development
    - MFDS Approval (IND, NDA)
    - IRB submission
    - Study Setup
    - Strategies and medical devices support for MFDS
  • DM/STAT/CSR
    - Preparation of DM plan / reports
    - Data Management CDM (RDC-based)
    - Statistical Analysis Plan (SAP)
    - Preparation for analyzed reports
    - Protocol & Epidemiology Research (ER)
    - Clinical Study Report (CSR) (Korean and English)
    Multinational Study
    - Feasibility study for Global Project
    - Global Project Management
    - Data Safety Monitoring Board (DSMB)
    - Medical Monitoring
    - DM, STAT, MW, QA
    - Translation, Printing of Clinical dossiers
    Quality Assurance
    - Audits for awarded Clinical Trial related Services
    - Good Clinical Practice (GCP) Audit
    - Risk-based Quality Management System (RQMS)
    - Good Laboratory Practice (GLP) / Good Clinical Laboratory Practice (GCLP)
    - Good Manufacture Practice (GMP)
    - SOP, QMS Consulting
  • Specified Work Dispatching
    - Medical Imaging Analysis
    - CDISC-related Consulting
    - SDTM-related Consulting
    - CTD, DMF, IB Consulting
    - Common Technical Document Development
    - Drug Maser File Development
    - Investigator Brochure Development
    R&D Center
    - R&D Strategic Consulting
    - CMC Consulting
    - Non-clinical study consulting
    Action Plan Keyword
    - Quality Assurance ↔ Smart
    - Time Schedule ↔ Speed
    - 1 Day Answer ↔ Smile
  • Clinical Operations
    - Site Management
    - Monitoring (PMP, SIV, IMV, COV)
    - Safety Management (SAE, AE)
    - Study Documentation (TMF, ISF, PF)
    - IP management (Local, Global)
  • Project Management
    - Kick-off Meeting
    - Project Team Training & Meeting
    - Project Management
    - External Supplier Sponsor Meetings
    - External Supplier Project Team Meetings
    - Distributor Work progression report
  • Regulatory Affairs
    - MFDS Approval (IND, NDA)
    - IRB submission
    - Study Setup
    - Project Development
    - Strategic & .Regulatory Affairs
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