Remove the Manual.
Automate Safety Case Processing & Reconciliation.
Intelligent case intake, automated E2B generation and cross-system reconciliation. Built to accelerate safety workflows and strengthen compliance.
Safety Case Processing, Made Easy.
ThoughtSphere automates safety case processing and reconciliation using its platform data engine and intelligent reconciliation module — reducing manual effort while increasing speed and accuracy.
E2B Transformation Engine Screenshot
Automated EDC-to-E2B transformation removes fragile custom integrations.
Automatically Transform EDC Safety Data to E2B
ThoughtSphere's platform ingests real-time safety data from EDC and automatically transforms it into ICH E2B-compliant XML using study-specific mapping rules.
Capabilities Include::
- ✓ System-agnostic ingestion via REST APIs, web services, or SFTP
- ✓ Automated transformation into the ICH E2B data model
- ✓ Study-specific mapping and normalization
- ✓ Automatic E2B XML file generation (initial + follow-up)
- ✓ Direct write-back to target destinations (SFTP, FTP, REST endpoints)
- ✓ Compatible with gateway transmission tools (e.g., AXWAY → safety system queues)
This removes fragile custom integrations and makes E2B generation repeatable and scalable across studies.
Continuous Cross-System Safety Reconciliation
ThoughtSphere's reconciliation module continuously compares safety data between EDC and safety system(s) on each data refresh and automatically flags mismatches.
Reconciliation Capabilities:
- ✓ Automated cross-system data comparison
- ✓ Configurable attribute and rule-based matching logic
- ✓ Discrepancy alerts when data is missing or inconsistent
- ✓ Fully equipped discrepancy review workbench with history and status
- ✓ Raise queries directly using EDC write-back capabilities
- ✓ Track reconciliation cycle times with built-in reports
This turns reconciliation from a periodic manual task into a continuous, intelligence-driven control process.
Reconciliation Workbench & Discrepancy Dashboard
Transform reconciliation from periodic manual task to continuous intelligence-driven control.
Outbound Configuration UI
Configurable intelligence enables faster triage and cleaner case packages.
Smarter Case Handling with Configurable Logic
Beyond transmission and reconciliation, ThoughtSphere adds configurable intelligence to safety case processing workflows.
Processing & Control Features:
- ✓ Conditional merging of related events into combined ICSR events
- ✓ Automatic conversion of EDC code lists and units to safety system standards
- ✓ Follow-up field configuration based on E2B XML updates
- ✓ Transmission monitoring using safety system Case IDs
- ✓ Case processing reports with full change visibility
This enables faster triage, cleaner case packages, and better downstream signal evaluation.
Make Safety Case Processing Predictable — Not Painful
See how ThoughtSphere automates safety case intake, E2B generation, reconciliation, and discrepancy management. See how smart technology can improve speed, accuracy, and safety compliance across your portfolio.