OUR SERVICES
Data Management
In the domain of Data Management, we present a flexible range of options to cater to your specific needs.
Our Data Management team is dedicated to following Good Clinical Data Management Practices (GCDMP) and adhering to the CDISC CDASH standard. Furthermore, they possess substantial experience in working with a range of Electronic Data Capture (EDC) systems, including Medidata RAVE, Oracle Inform, Oracle Clinical One, and Viedoc EDC. This proficiency ensures the effective management of clinical data and compliance with industry standards.
  • 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
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