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Data Management


Services offered:

  • Set-up of the clinical database in Oracle Clinical
  • Double data entry
  • Validation and plausibility checks
  • eCRF/RDC (Remote Data Capture)
  • Reconciliation of safety data
  • Integration of Dictionaries using latest version of MedDRA and WHO ATC into the Thesaurus  Management System within Oracle Clinical


Reporting of:

  • Data Handling Manual
  • Data Management/Validation Plan
  • Data Management/Validation Report
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