ArisGlobal
AI-powered safety, regulatory, quality, and medical affairs workflows for drug development and pharmacovigilance.
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Overview
ArisGlobal develops the LifeSphere® platform, an AI-powered software suite designed for life sciences organizations involved in drug development and commercialization. The platform covers Safety, Regulatory, Quality, and Medical Affairs functions, and is used by more than 220 organizations across the industry. LifeSphere is delivered as a SaaS-based, interoperable set of modules that incorporate generative AI and agentic AI capabilities to support end-to-end data management and workflow automation.
A core element of ArisGlobal's current offering is NavaX™ Agents, a set of purpose-built autonomous AI agents designed for Safety and Regulatory workflows. These agents are intended to orchestrate data and processes, support decision-making at scale, improve consistency and quality, and continuously learn from human input and context.
LifeSphere Platform Modules
- LifeSphere Safety: Described as the only unified, next-generation SaaS safety platform in production, it is designed to support touchless case processing, scalable compliance, and standardized global pharmacovigilance workflows.
- LifeSphere Regulatory: Addresses the end-to-end regulatory lifecycle by bringing together data, content, and processes, and embedding current technologies to go beyond the capabilities of legacy regulatory systems.
- LifeSphere Quality: Provides a complete quality management and documentation solution for life sciences companies, covering industry-specific requirements across R&D, Clinical, Regulatory, Pharmacovigilance, and Manufacturing.
- LifeSphere Medical Affairs: Enables information flow and automation across Medical Affairs and Safety functions, with the aim of improving efficiency, enhancing compliance, and accelerating responses based on current product information.
NavaX™ Agents — Agentic AI Capabilities
- Purpose-built autonomous intelligence applied to Safety and Regulatory workflows
- Supports more rapid, holistic, and scalable decision-making
- Designed to enhance consistency and quality across processes
- Capable of continuous learning from human input and operational context
- Intended to provide confidence in AI-supported insights
- Applied to pharmacovigilance areas including safety distribution, signal management, and risk management
Regulatory Intelligence and Compliance
- Includes modular AI offerings to track global regulatory changes
- Supports SPOR and ISO IDMP compliance acceleration, including through a capability referenced as Sporify
- Designed to help organizations manage RIM system compliance with AI assistance
Deployment and Customer Base
- Platform is delivered via SaaS deployment
- Trusted by more than 220 life sciences organizations
- Serves companies across pharmaceutical, biotech, and related life sciences sectors
- Modules are designed to be interoperable across the LifeSphere suite
ArisGlobal positions LifeSphere as a unified platform for life sciences teams seeking to consolidate Safety, Regulatory, Quality, and Medical Affairs operations within a single, AI-embedded environment, with ongoing development focused on agentic AI applications across pharmacovigilance and regulatory workflows.
Software
Advanced Compliance Docs
Medical writing automation and safety document management for creating, storing, and managing PSMF, PVAs, and critical safety documentation.
Advanced Signals
Signal and risk management with GenAI-powered detection, case evaluation, and automated workflows for pharmacovigilance.
Analytics
Advanced reporting and dashboards for tracking, compliance, and decision-making across regulatory operations.
Business Intelligence
Real-time safety analytics and ad-hoc reporting for drug safety compliance and decision-making.
Document Distribution
Automated distribution and oversight of safety reports to stakeholders with audit-ready tracking and regulatory compliance.
Documents
Centralized repository for regulatory submission content with document control, compliance support, and submission-ready workflows.
Health Authority Interactions
GenAI-powered intake and management of health authority communications with centralized knowledgebase and automated response drafting.
Labeling
End-to-end labeling change management and compliance tracking for pharmaceutical operations.
LifeSphere Advanced Intake
Safety case intake automation using GenAI and LLMs to extract data from diverse sources and generate narratives with >90% accuracy.
Literature Intelligence
GenAI-powered medical literature screening and intake automation for drug safety workflows, with system-agnostic integration and compliance.
Medical Information
Unified medical inquiry and complaint management with multi-channel intake automation and real-time analytics for global teams.
MultiVigilance
Automated end-to-end case processing and management for drug safety with AI-powered compliance and global harmonization.
NavaX Translation
Automated multilingual case intake with AI translation and intelligent language detection for global pharmacovigilance workflows.
Product Compliance
Medicinal product data management and submission compliance for xEVMPD and IDMP requirements.
Regulatory Intelligence
Automated regulatory monitoring and centralized knowledgebase for compliance, powered by GenAI automation.
Reporter
Mobile and web case intake for adverse event reporting, medical inquiries, and safety information collaboration across field stakeholders.
ReporterX
AI-assisted front-end data collection for adverse events, medical information, and product quality complaints with real-time mobile and web reporting.
RIM
Regulatory planning, tracking, and registration management across the product lifecycle with global oversight and AI-powered compliance automation.
Submissions
Create, compile, and publish regulatory submissions in any format with streamlined workflows and automated national submission generation.