Data Management

Our Data Management offers full-service, select services or functional service provider (FSP) partnership. DM team follows Good Clinical Data Management Practices (GCDMP), CDISC CDASH standard and is experienced in working with Medidata RAVE, Oracle Inform , Oracle Clinical One and Viedoc EDC systems.

  • Defining of EDC system set-up requirements
  • Developmentvalidation and maintenance of the following systems/components:
    • e-CRF (screens, edit checks, notifications, alerts, clinical trial metrics)
    • ePRO
    • Randomization and Trial Supply Management (RTSM) system
    • eConsent
    • Medical coding
    • Data import/export
  • Devices (e.g. wearables) configuration, data collection and analysis
  • Systems setup for User Acceptance Testing (UAT)
  • Thesaurus dictionaries coding
  • Collected data validation and review
  • Clinical trial progress metrics reporting and alerts
  • Protocol deviation identification and reporting
  • External vendor data upload and reconciliation
  • Interim analysis/(B)DRM conduct
  • Data lock and transfer
Data Management