The first AI-native operating system for patient safety
Unifying source, intake, case processing, aggregate reporting, signal detection, risk management and regulatory compliance, into one connected intelligent ecosystem.
End-to-end pharmacovigilance in one intelligent system
From case to regulator-ready report — automatically aligned and delivered.
/signal
November ‘26
Detect emerging safety patterns across cases
Surface cross-case signals, trends, and event relationships earlier.
/assure
January ‘27
Validate cases continuously during processing
Identify inconsistencies, missing data, and review gaps automatically.
/comply
January ‘27
Embed compliance directly into operations
Maintain auditability, traceability, and regulatory alignment continuously.
90% Reduction in effort
92% faster processing
66% cost savings
Traceable from Day Zero
How the system operates
Four capabilities continuously enabling connected, expert-guided safety and regulatory workflows.
Understand context
Interprets unstructured safety data with domain-aware intelligence
Connect data
Links cases, signals, and sources into a unified knowledge graph
Automate Intelligence
Automates workflows, triage, and reporting across the lifecycle
Expert in the loop
Keeps your team in control with review, validation, and override at every step
Curated
safety data
Connected
case records
Contextual
clinical insights
Compliant
submission assurance
Designed as an AI-native safety system
Graph safety continuously understands, validates, and connects workflows across the pharmacovigilance lifecycle.
Maintains operational continuity
The system continuously connects evidence, workflows, and downstream safety decisions.
Validates continuosly, not in stages
Validation is embedded throughout processing to identify inconsistencies, gaps, and compliance risks in real time.
Surfaces decisions, not tasks
Graph Safety reduces manual coordination so reviewers can focus on clinical and regulatory judgment.
Keeps humans in control
Human oversight remains embedded throughout validation, review, and safety decision-making.
Built for regulatory environments
Aligned with global pharmacovigilance standards with traceability, auditability, and oversight embedded throughout.
Every action logged
Every field is traceable
Every workflow auditable
Every decision reviewable
Engineered on enterprise-grade AI infrastructure
Secure, scalable infrastructure purpose-built for continuous safety operations.
Vertex AI for medical reasoning
Kubernetes-native orchestration
Enterprise-grade security
AI models built for security operations
Trusted by patient safety teams worldwide
Global Biopharma
AI-native literature intake operations
90% Efficiency
55% Savings
Unified literature monitoring, intake validation, and downstream case preparation into one continuously monitored safety workflow.
Fragmented intake systems consolidated into a single operational workflow.
Mid-Size Pharmaceutical Organization
End-to-end pharmacovigilance orchestration
90% Efficiency
100% Audit Ready
Connected intake, case processing, review, and regulatory submission into a continuously validated safety system with explainable reasoning.
Submission-ready safety operations delivered through one intelligent platform.
Healthcare CRO & PSP Provider
Unified patient support and safety operations
82% Efficiency
100% PHI Privacy
Unified literature monitoring, intake validation, and downstream case preparation into one continuously monitored safety workflow.
Consolidated legacy systems into a single unified OS.
Enterprise-grade safety intelligence
Reimagined AI for meaningful patient safety insights
Efficiency gains, verifiability, and guard-railed causality
Explainable scientific rigor via auditable logs
Everything your safety system should do is already done
An intelligent patient safety system that automates, connects, and validates every stage of the safety lifecycle — so teams can focus on clinical and regulatory judgment.