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 — reducing manual effort while increasing speed and accuracy.
Automated safety case synchronization between EDC and safety database
Transforms ingested EDC safety data to E2B using the platform's patented transformation engine
Near real-time detection of discrepancies and missing data
Full reporting compliance and audit readiness
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:
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System-agnostic ingestion via REST APIs, web services, or SFTP
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Automated transformation into the ICH E2B data model
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Study-specific mapping and normalization
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Automatic E2B XML file generation (initial + follow-up)
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Direct write-back to target destinations (SFTP, FTP, REST endpoints)
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Compatible with gateway transmission tools (e.g., AXWAY → safety system queues)
Automated EDC-to-E2B transformation removes fragile custom integrations.
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:
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Configurable attribute and rule-based matching logic
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Automated Discrepancy alerts when data is missing or inconsistent
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Fully equipped discrepancy review workbench with history and status
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Raise queries directly using EDC write-back capabilities
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Track reconciliation cycle times with built-in reports
Transform reconciliation from periodic manual task to continuous intelligence-driven control.
Smarter Case Handling with Configurable Logic
Beyond transmission and reconciliation, ThoughtSphere adds configurable intelligence to safety case processing workflows.
Processing & Control Features:
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Conditional merging of related events into combined ICSR events
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Automatic conversion of EDC code lists and units to safety system standards
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Follow-up field configuration based on E2B XML updates
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Transmission monitoring using safety system Case IDs
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Case processing reports with full change visibility
Configurable intelligence enables faster triage and cleaner case packages.
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.