Safety Case Processing & Reconciliation

Safety Case Processing & Reconciliation is a module within the ThoughtSphere platform designed for clinical trial teams that need to reduce manual effort in safety data handling. It targets the transformation of electronic data capture (EDC) safety data into standardised E2B formats and the ongoing reconciliation of safety records between systems, with the stated goal of reducing effort by up to 95% through automation.

E2B R2 File Generation

• Transforms EDC safety data into the ICH E2B data model.
• Conditionally merges related safety events to produce a combined safety case.
• Automatically converts EDC code lists and measurement units to align with the standardised values used in the Safety Database.
• Provides out-of-the-box safety case reports and dashboards for process oversight.

Automatic System-to-System Reconciliation

• Runs continuous, around-the-clock comparisons between the EDC and the Safety System.
• Auto-detects discrepancies with each data refresh and sends action alerts to relevant users.
• Allows users to create queries directly within the platform, which are written back to the EDC for sites to address.

The module is part of ThoughtSphere's broader unified clinical data platform, which also covers study oversight, risk-based quality management, medical monitoring, data science, biostatistics, and site payments. It is positioned for organisations seeking to improve compliance and reduce manual reconciliation work across EDC and safety systems.