Safety Case Processing & Reconciliation

Save Time and Improve Quality

Reduce Effort by up to 95% through automated E2B File transformation & safety reconciliation

Smart E2B R2 File Generation

  • Transform EDC safety data into the ICH E2B data model with ease
  • Conditionally merge related safety events to create a combined safety case
  • Auto convert EDC code lists and measurement units to align with the Safety Database’s standardized values
  • View out-of-the box safety case reports & dashboards for complete process oversight

Automatic System to System Reconciliation

  • Save time and improve compliance with around-the-clock system to system comparisons.
  • Auto-detect discrepancies between the EDC and Safety System with each data refresh and send action alerts
  • Create queries directly in the platform to be written back to the EDC for the site to address

Unlock the Potential of Unified Clinical Data with ThoughtSphere!

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