LifeSphere Safety AI Pharmacovigilance Platform

ArisGlobal was founded in 1987 and introduced the first commercially available drug safety system. Headquartered in the United States with regional offices in Europe, India, Japan and China, it works with more than 220 life sciences companies, CROs and health authorities, including the FDA, Health Canada and China's NMPA, on safety, regulatory and quality processes.

LifeSphere Safety is a unified SaaS pharmacovigilance system with AI and automation from its NavaX layer. MultiVigilance manages adverse event cases end to end, Advanced Intake extracts case data with generative AI, Literature Intelligence screens published references, and Advanced Signals supports signal detection. NavaX agents handle MedDRA coding, distribution, signal and translation tasks, and the platform supports E2B(R3) reporting with business intelligence dashboards.

• MultiVigilance: end-to-end adverse event case management with automation.
• Advanced Intake: generative AI extraction of case data from incoming reports.
• Literature Intelligence: automated intake and assessment of published references.
• Advanced Signals: signal detection and case assessment with fewer false positives.
• NavaX agents: MedDRA coding, distribution, signal and translation agents.
• Business Intelligence: 50+ ready-made reports and dashboards for PV operations.

Vietnamese drug manufacturers can centralise adverse event reporting and literature monitoring for domestic and export products. Regional affiliates of multinational pharma firms can process local safety cases in a global system. CROs can offer outsourced pharmacovigilance services on a validated platform.

The company reports up to 65% faster case intake with generative AI extraction and up to 70% faster literature reference processing. Advanced Signals is said to make case assessment up to 80% faster with fewer false positives. Advanced Compliance Docs reportedly speeds medical authoring by up to 70%. As SaaS, regulatory updates such as E2B(R3) are delivered without heavy IT work.

Adverse event volumes keep rising, and pharmacovigilance teams are turning to AI to process cases and literature without adding staff. Regulators worldwide are moving to E2B(R3) electronic reporting. Vietnam's drug administration is strengthening post-marketing surveillance, so local manufacturers and multinational affiliates need structured, auditable safety systems.

Founded in 1987; headquartered in the United States with offices in Europe, India, Japan and China. In July 2026 Dassault Systèmes announced plans to acquire ArisGlobal; the LifeSphere brand continues. Named a Visionary Leader in the 2026 Frost Radar for regulatory information management. Extended a seven-year FDA pharmacovigilance partnership with Chickasaw Nation Industries.