CLINICAL DATA MANAGEMENT

 

  • Data management plans and guidelines
  • Paper CRF based clinical studies
  • Electronic Data Capture Studies (EDC)
  • Rescue Studies (Paper CRF/ eCRF)
  • IVR
  • Database design
  • Full data integration (eCRF, IVR, laboratories, images and other instrumentation)
  • Data validation and review
    – Data validation checks
    – Logic checks
    – Programmatic queries
  • eCRF design
  • eCRF generation and initial edit check specifications
  • eCRF completion guidelines
  • Non-logic consistency checks (manual/clinical data review and query generation)
  • Manual query generation and resolution
  • Medical term coding (MedDRA, WHODD, COSTART, ICD-9, client dictionaries)
  • Data exports
  • Final quality checks of study data

 

 

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