/intake

graph safety /intake is a safety data intake product designed for pharmacovigilance and drug safety teams. It acts as a controlled entry point that consolidates fragmented safety inputs from multiple sources into a single governed intake layer, establishing structure, traceability, and semantic context at the start of the safety workflow. The product is intended to address the challenge of managing safety data spread across legacy systems, spreadsheets, and organisational silos, where reconciling conflicting records delays insights and increases compliance risk.

/intake is part of the graph safety suite and is positioned as a foundation layer that prepares safety data for downstream processing. It applies ontology-driven data models and automation while retaining expert human review at critical decision points, with compliance aligned to EMA GVP Module VI expectations.

Multi-Channel Data Ingestion

• Ingests safety data from MICC literature, email, social media, partner systems, patient programmes, clinical trials, and regulatory channels through a single controlled intake gateway.
• Brings multi-source inputs together before any downstream processing occurs.
• Applies a harmonised data model aligned with MedDRA, WHODrug, SNOMED CT, and E2B R3 standards to establish semantic relationships across safety signals.
• Structures case information — including patient, drug, condition, procedure, and event data — from unstructured sources to ensure completeness at intake.

Intelligent Automation Capabilities

• Provides context-aware MedDRA auto coding from adverse event narratives, reducing variability and manual coding effort.
• Detects duplicate cases using multi-factor matching across molecular structure, patient attributes, timelines, and source attribution.
• Assigns confidence scores to every extraction and inference, allowing reviewers to direct attention to cases where human judgement is most needed.

Workflow Routing and Prioritisation

• Automatically routes cases based on SLA urgency and reviewer availability to reduce bottlenecks and missed timelines.
• Surfaces the most critical cases first, aligned with regulatory timelines and medical impact.
• Supports an expert-in-the-loop model where automation handles extraction, coding, and routing while human experts focus on clinical judgement and final decisions.

Traceability, Explainability, and Compliance

• Preserves original safety artefacts with full traceability across intake, processing, and review stages, supporting audit and inspection readiness.
• Provides citations and rationale for every extraction and inference to support transparency and regulatory confidence.
• Compliant with GVP Module VI, ensuring accessibility, integrity, and controlled collation of safety reports in line with EMA expectations.

/intake is designed to serve as a trusted, structured foundation for downstream pharmacovigilance workflows, with compliance and auditability built into the intake process from the outset rather than applied retrospectively.