ArisGlobal Earns 2025 Global New Product Innovation Recognition for Intelligent MedDRA Coding
Frost & Sullivan has recognized ArisGlobal with the 2025 Global New Product Innovation Recognition in intelligent MedDRA coding. For product leaders in safety and regulatory tech, this signals a credible, validated path to automation that improves accuracy, speeds compliance workflows, and reduces reviewer burden at scale.
The core of the recognition is ArisGlobal's MedDRA Coding Agent, powered by LifeSphere NavaX. It applies agentic AI to interpret nuanced clinical language, select tools dynamically, and learn from reviewer feedback. The result: more precise coding, fewer manual touches, and faster case closure with clear auditability.
The Agent is multilingual and integrates with existing safety databases and regulatory systems, making global rollouts more straightforward. It also escalates only the most complex cases with ranked suggestions and transparent rationales so reviewers spend time where it matters.
What Frost & Sullivan Noted
"ArisGlobal places innovation at the center of its growth strategy with LifeSphere NavaX serving as the cornerstone of its AI vision," said Norazah Bachok, Best Practices Research Analyst at Frost & Sullivan. "This first-of-its-kind Agent is adaptive, auditable, and enterprise-ready, enabling up to 80% efficiency gains, significantly easing reviewer workload and eliminating unnecessary noise while maintaining uncompromising accuracy."
"The MedDRA Coding Agent represents a major leap forward in pharmacovigilance automation," said Jason Bryant, SVP, Product Management - AI at ArisGlobal. "By combining the cognitive depth of agentic AI with the proven intelligence of LifeSphere NavaX, we're transforming complex coding workflows into intelligent, adaptive processes that deliver greater accuracy and efficiency at scale."
What Makes the MedDRA Coding Agent Different
- Context-aware interpretation of clinical language for precise MedDRA term selection.
- Dynamic tool use and continuous learning from reviewer feedback and updates to medical terminology.
- Intelligent case collaboration: escalates only complex cases with ranked options and clear rationales.
- Multilingual coverage for global operations and seamless integration with safety/regulatory systems.
- Auditable decision trails to support inspections and internal quality reviews.
Product Implications for PV and Regulatory Teams
- Higher first-pass automation and accuracy, less rework, and faster case cycle time.
- Lower reviewer workload with clear guardrails and transparent decisions.
- Consistent coding standards across markets and languages, supporting global harmonization.
- Built-in auditability to reduce compliance risk and inspection findings.
Integration and Deployment Notes
The Agent connects to existing safety databases and regulatory ecosystems, reducing disruption. Still, successful rollout depends on data readiness, clear governance, and well-defined KPIs.
- Prereqs: clean dictionaries, standardized source fields, and clear coding rules.
- Human-in-the-loop: set thresholds for auto-accept, auto-reject, and mandatory review.
- Change management: train reviewers on rationale review, feedback loops, and escalation cues.
- Governance: document model behavior, audit logs, and SOP updates for inspections.
- Security and privacy: validate access controls and data handling across regions.
KPIs to Track Post-Launch
- First-pass automation rate and coding accuracy.
- Reviewer time per case and overall case cycle time.
- Escalation rate and acceptance rate of ranked suggestions.
- Audit findings related to coding decisions and rationale quality.
- Language coverage performance and drift over time; retraining cadence.
Why This Recognition Matters
Frost & Sullivan's Best Practices Recognitions are benchmarked against two dimensions: strategy effectiveness and strategy execution. ArisGlobal excelled in both, aligning product strategy to market needs while executing with scale and transparency.
For product teams, this reduces uncertainty around vendor maturity and implementation risk. It's a signal that the category is maturing and ready for wide deployment.
How Frost & Sullivan Evaluates
Each year, the New Product Innovation Recognition highlights products with strong technical merit and clear commercial potential. Evaluations draw on in-depth interviews, analysis, and secondary research to assess leadership, innovation, customer impact, and product strategy.
- Learn more about MedDRA standards at meddra.org.
- See Frost & Sullivan's Best Practices framework at frost.com.
Action Steps for Product Leaders
- Run a 60-90 day pilot across high-volume and multilingual case types; baseline KPIs before kickoff.
- Define escalation rules and acceptance thresholds with Safety and QA upfront.
- Integrate reviewer feedback loops to continuously improve precision and reduce noise.
- Align SOPs, training, and audit requirements before scaling to new regions or products.
- Set quarterly model governance reviews for drift, retraining, and change control.
The Bigger Picture
ArisGlobal's continued investment in cognitive computing, multilingual processing, and automation points to a product roadmap built for scale. For organizations seeking measurable gains in accuracy, speed, and compliance, intelligent coding is moving from "nice to have" to standard infrastructure.
- For upskilling teams building AI-enabled workflows, explore practical automation resources at Complete AI Training - Automation.
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