Use cases

Operational AI for regulated life sciences.

Illustrative examples from pharmacovigilance, clinical operations, and regulatory affairs. These are not a fixed catalog. Every engagement starts with your problem, then we decide whether an existing pattern fits, adapt it, or build something new.

01 · Pharmacovigilance & safety

SDI: Safety Decision Intelligence.

An AI-enabled agent that ingests safety documents and data across multiple sources, performs structured intelligence assessment, and produces audit-ready outputs for health-authority requests and signal evaluation.

Capabilities

  • Document summarization
  • Signal intelligence & assessment
  • Case prep & narrative support

Outcomes

  • Defensible HA responses
  • Earlier signal identification
  • Consistent ICSR narratives at scale
21 CFR Part 11 EU AI Act Art. 9 / 13 / 14 ICH E2B(R3) ISO 42001 Immutable audit trail HITL review

Experience the demo

1
IngestICSRs, PSURs, DSURs, literature, HA queries
2
AnalyzeSummarize, synthesize signals, generate narratives
3
ReviewHuman-in-the-loop validation & sign-off
4
OutputHA assessments, signal summaries, narratives

Beyond safety

Patterns across the R&D lifecycle.

02 · Clinical operations

Protocol Deviation Pattern Detection

Identify recurring deviation patterns across sites and studies to enable proactive, risk-based monitoring.

Outcomes

  • Cross-site pattern detection that isolates systemic issues early
  • Improved CAPA targeting and inspection readiness
03 · Regulatory affairs

Regulatory Intelligence & Label-Change Monitoring

Automated tracking of HA guidance, label changes, and competitive intelligence across global markets.

Outcomes

  • Faster regulatory awareness across jurisdictions and products
  • Reduced manual monitoring burden with delta summarization

Custom use cases

Don't see your challenge here?

Every engagement starts with a conversation. Tell us the problem, and we will tell you what is realistic.