From fragmented intake to

continuously structured safety operations

Every inbound artifact is automatically classified, validated, routed, and prepared
for downstream pharmacovigilance workflows.

Continuous intake workflows,
fully orchestrated

Every inbound artifact is extracted, classified,
validated, and routed automatically across
downstream safety operations.

Multi-channel Ingestion

Email, PDF, XML, APIs, literature, and partner feeds unified into one intake system.

AI-powered extraction

Patient, drug, event, timeline, and clinical context extracted automatically.

MedDRA classification

Context-aware coding with continuously validated terminology alignment.

Cross-source deduplication

Duplicate detection across literature, partner, and spontaneous reporting channels.

Continuos validation

Completeness, consistency, and compliance checks embedded throughout intake.

Intelligent routing

Artifacts classified and routed automatically across downstream safety workflows.

Continuous intake
intelligence in action

Every inbound artifact is extracted, classified,
validated, and routed automatically across
downstream safety operations.

AI-native intake with
configurable human oversight

Confidence-based routing allows organizations
to calibrate operational automation against regulatory
and clinical risk tolerance.

Translate only what requires
legal-grade review

Graph Safety automatically classifies translated
content before invoking full legal translation
workflows for reportable ICSRs.

Connected downstream
safety operations

Structured, validated intake outputs flow directly
into downstream pharmacovigilance systems
through APIs and machine-readable integrations.

Faster implementation
timelines

Deploy within existing
safety infrastructure

Reduced migration
complexity

No system replacement required


Structured downstream
interoperability

Standards-compliant case payloads


Lower operational

disruption

Existing workflows remain intact


Regulatory confidence at every step

Traceable AI reasoning, configurable oversight, and structured
auditability remain embedded throughout intake operations.

Audit

traceability

Complete audit trail from source artifact to downstream system

21 CFR Part 11 compliant
Decison
Explainability

AI decision reasoning logged and retrievable for inspection

Model version tracked
Human
accountability

GVP Module VI , ICH E2B (R3) , CIOMS , FDA MedWatch ready.

Role-based verification
Compliance
alignment

GVP Module VI , ICH E2B (R3) , CIOMS , FDA MedWatch ready.

Continuously validated

Operationalize every safety signal
from Day Zero

Enable faster safety decisions, greater regulatory confidence,
and more reliable patient safety outcomes across every source.