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Smart Intake

Smart Intake automates the entire safety case intake process—from ingestion to an ICSR report—using AI for fast, accurate, compliant case processing.

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Smart Intake Workflow

  • INPUT : Smart Intake captures safety reports from any format, language, or source—including documents, emails, mobile apps, APIs, literature, and secure folders. It automatically ingests, organizes, and manages all inputs with full email/file handling, acknowledgements, and routing. Automated literature search and screening ensure no relevant case is missed.

  • EXTRACT : Smart Intake performs precise data extraction and standardization, eliminating manual redaction, classification, duplicate detection, translation, coding, and data entry. It produces clean, structured, regulatory-ready data within seconds.

  • REVIEW : Smart Intake offers a side-by-side verification view that shows exactly where each extracted data point came from. Users can validate and correct data with full audit trails, while automated follow-ups, task tracking, and alerts streamline the entire intake process.

  • SEND : Smart Intake automatically generates complete E2B(R2)/E2B(R3) ICSRs with source documents attached. These review-ready case packages integrate smoothly with any safety database or workflow.

Smart Intake Workflow

Key Features of Smart Intake

  • Multi-source intake : Captures safety reports from any format, language, or channel with automated ingestion.

  • AI-powered data extraction : Automatically extracts and standardizes all key safety data with high accuracy.

  • Smart case classification : Identifies initial/follow-up cases, detects duplicates.

  • Side-by-side verification : Shows the exact source of each extracted data point for quick review and correction.

  • Automated E2B generation : Creates complete, compliant E2B(R2/R3) cases ready for seamless safety system integration.

  • End-to-End Auditability & Traceability : Every action, correction, and decision is logged, ensuring transparency and enabling automated learning for more accurate future extractions.

Key Features of Smart Intake

Compliance & Security

Smart Intake is designed for regulated pharmacovigilance environments, ensuring data integrity, traceability, and full compliance with global safety requirements. It provides enterprise-grade security and robust auditability across every step of the intake workflow.

  • GVP-Compliant Workflows : Supports industry best practices for safety case intake, documentation, and traceability.

  • 21 CFR Part 11 / EU Annex 11 Ready : Electronic records, signatures, and audit logs meet regulatory expectations for validation and data integrity.

  • Full Audit Trail & Traceability : Every data extraction, edit, review, and system action is timestamped and traceable for inspection readiness.

  • Secure Role-Based Access Control : Granular permissions ensure the right users access only the right data and functions.

  • Encrypted Data Handling : All data—at rest and in transit—is encrypted using industry-standard security protocols.

Compliance & Security

Explore Smart Intake Now !

Smart Intake is an AI-powered safety case intake system that captures reports from any source or format, extracts and standardizes key data automatically, and streamlines review with intuitive verification and audit trails. It produces complete, compliant E2B(R2/R3) cases ready for seamless integration into any safety system, drastically reducing manual effort and processing time.