Data Management

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
• Development, validation 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