지디에프아이 브레인셀연구소

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Specified Worker Dispatching

다양한 경험과 전문성을 기반으로 한 GDFI Braincell Laboratory

임상시험 글로벌 규정과 임상의학적인 기술이 지속적으로 진보됨에 따라 새로운 글로벌 표준화의 적용에 대한 고객사의 요구를 수용할 수 있도록 특화된 업무 서비스를 제공해 드리고 있습니다.

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8-1. Medical Imaging Analysis

  • Support to Diagnostic Radiology Central Review (DRCR) analysis utilizing data of medical diagnostic imaging (X-ray, CT, MRI and PET-CT)
  • Framework for medical diagnostic imaging analysis system
  • Support to collection of imaging data
  • Provision of image acquisition guidelines
  • Support to DRCR committee and provision of database for DRCR results
  • Preparation of DRCR results reports
  • Medical diagnostic imaging consulting
  • Support to Diagnostic Radiology Central Review (DRCR) analysis utilizing data of medical diagnostic imaging (X-ray, CT, MRI and PET-CT)
  • Framework for medical diagnostic imaging analysis system
  • Support to collection of imaging data
  • Provision of image acquisition guidelines
  • Support to DRCR committee and provision of database for DRCR results
  • Preparation of DRCR results reports
  • Medical diagnostic imaging consulting
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8-2. CDISC-related Consulting

  • CRF design (CDASH), eCRF design (CDASH)
  • Analysis Data Model (ADaM) tasks
  • Analysis Dataset Metadata
  • Dataset specifications
  • Programming
  • ADaM datasets, Define, xml package generation
  • Analysis results / programming, TFLS generation
  • CRF design (CDASH), eCRF design (CDASH)
  • Analysis Data Model (ADaM) tasks
  • Analysis Dataset Metadata
  • Dataset specifications
  • Programming
  • ADaM datasets, Define, xml package generation
  • Analysis results / programming, TFLS generation
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8-3. SDTM-related Consulting

  • Dataset specification
  • Programming
  • SDTM datasets, Define, xml package generation
  • Dataset specification
  • Programming
  • SDTM datasets, Define, xml package generation
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8-4. CTD, DMF, IB Development Consulting

  • Common Technical Document Development
  • Drug Master File Development
  • Investigator Brochure Development
  • Common Technical Document Development
  • Drug Master File Development
  • Investigator Brochure Development
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