A Breakthrough in AI-Powered Pharmacovigilance, the Agent will transform MedDRA coding with context-aware, autonomous decision-making.

Boston, Massachusetts, USA – April 18, 2025 –ArisGlobal, an innovative technology company at the forefront of life sciences and creator of LifeSphere®, today at Breakthrough Tokyo announced the launch of its newest NavaX Agent for MedDRA Coding. The transformative solution applies Agentic AI to revolutionize pharmacovigilance operations, pushing beyond automation into intelligent autonomy.

The NavaX Agent for MedDRA Coding is not just an enhancement — it’s a rethinking of what’s possible. It emulates how experienced pharmacovigilance professionals work: understanding clinical context, planning tasks dynamically, learning from reviewer feedback, and collaborating when appropriate. The result is a smarter, more adaptive approach to medical coding that delivers both speed and accuracy.

“With NavaX Agents, we’re delivering intelligent automation that doesn’t just execute tasks but makes context-aware decisions,” said Ann-Marie Orange, CIO and Global Head of R&D at ArisGlobal. “This is true Agentic AI in action — systems that adapt, learn, and act with purpose.”

Addressing a Longstanding Challenge in Safety Operations

MedDRA coding has long relied on rigid keyword matching and rule-based systems that struggle to scale. With inconsistent mappings, limited context, and heavy reviewer burden, traditional tools fall short of modern pharmacovigilance demands.

The NavaX Agent for MedDRA Coding solves these limitations by:

• Understanding Clinical Context – Interprets nuanced language like “threw up everything” as “Vomiting,” not just based on keywords but underlying clinical meaning.
• Using Modular Tools Intelligently – Dynamically chooses tools like normalizers or validators based on complexity.
• Learning Over Time – Adapts to coding patterns, reviewer feedback, and organizational preferences.
• Collaborating Intelligently – Escalates cases only when needed, providing ranked suggestions with rationale.
• Ensuring Full Auditability – Provides clear traceability and decision explanations in line with regulatory requirements.

The Results Speak for Themselves

• 80%+ efficiency gains in MedDRA coding automation.
• Significant reduction in reviewer workload and SOC (System Organ Class) noise.
• Built for enterprise use with multilingual support, regulatory compliance, and seamless integration into existing PV systems.

Flexible, Future-Proof Deployment

The NavaX Agent for MedDRA Coding is available as a standalone subscription or as part of the LifeSphere® NavaX platform, enabling organizations to scale automation according to their needs. This latest addition joins the previously announced NavaX Insights Agent, forming a powerful AI-driven suite purpose-built for next-generation pharmacovigilance.

About ArisGlobal

ArisGlobal, an innovative life sciences technology company and creator of LifeSphere®, is transforming the way today’s most successful life sciences companies develop breakthroughs and bring new products to market. Headquartered in the United States, ArisGlobal has regional offices in Europe, India, Japan, and China. For more updates, follow ArisGlobal on LinkedIn. www.arisglobal.com.