Safety Case Transformation & Reconciliation

Save Time and Improve Quality

A scalable and repeatable way to transform safety case data into E2B R2 Files and automate safety data reconciliation

Smart E2B R2 File Generation

  • Aggregation & Transformation of EDC & Other Source data structures into E2B R2 XML structure
  • Option to conditionally merge related events to create a combined safety case
  • Auto convert EDC code lists and measurement units to align with the Safety Database’s standardized values

Automatic System to System Reconciliation

  • Outbound write to SFTP to transmit (and reconciliation transmission) between systems
  • Reporting capability to identify data changes to safety cases to support safety case processing

Unlock the Potential of Unified Clinical Data with ThoughtSphere!

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