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

/report

August ‘26

Generate regulator-ready outputs automatically

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.