지디에프아이 브레인셀연구소

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Scope of Service

국제법령과 글로벌 임상표준화를 충족하는 GDFI Braincell Laboratory

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
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