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!