ArisGlobal

ArisGlobal offers an AI-first platform for life sciences R&D: more than 220 organizations use its LifeSphere solutions across safety, regulatory, quality and medical affairs, with its NavaX AI built in.

Safety, Medical Information, and Quality Work

• Capture and triage safety cases with LifeSphere MultiVigilance, a safety system with production-ready automation. PV automation supports data extraction from structured and unstructured safety cases, while safety database workflows support expedited reporting and regulatory submissions.
• Manage medical inquiries and related information with its Medical Information solution, powered by NavaX. Teams can process product complaints and adverse events, maintain and share compliant information, and use conversational AI for routine inquiries and basic external queries via chatbot; ReporterX, an AI-assisted front-end patient data collection and reporting application, can identify missing information during initial interactions and help reports arrive more complete downstream.

Quality Management and Product Complaints

• Run quality operations with the Electronic Quality Management System, powered by NavaX, a cloud solution with AI-enabled workflows. Teams can manage deviations, complaints, non-conformances, out-of-specification results, CAPA, investigations, root cause analysis, and change control.
• Control quality documentation and product complaints through workflows for authoring, approval, distribution, tracking, storage, intake, data validation, classification, and assessment. Product complaint workflows can directly link product complaints with adverse event cases, while document controls use metadata, versioning policies, roles, and permissions.

Regulatory Information and Safety Governance

• Manage regulatory planning, tracking, and registration through RIM, while submission workflows support creating, compiling, and publishing submissions in any format. Product data workflows support xEVMPD and IDMP requirements, including real-time SPOR updates through SPORIFY, a tool for matching, maintaining, synchronizing, and integrating reference data.
• Support safety governance with benefit-risk analysis, signal detection, risk management plan management, PSMF lifecycle controls, PV regulatory intelligence, and pharmacovigilance agreement workflows. Teams can monitor regulatory updates, track their impact, maintain inspection-ready PSMFs, and create, review, approve, and maintain PVAs using standardized templates and workflow automation.

Data, Reporting, and Regulatory Content

• Standardize meaning and context across R&D and business operations with XDI, a unified, system-agnostic data layer. PV teams can also use a unified hub for reporting, analytics, and visualization, while signal workflows support quantitative and qualitative statistical methods for signal detection.
• Prepare regulatory content with AI-assisted information gathering, synthesis, contextualization, and report-template population. Regulatory labeling supports change management and compliance tracking, and document-distribution workflows apply configurable rules by product, study, site, and country.

Best Fit

• ArisGlobal fits life sciences organizations seeking software for pharmacovigilance, quality management, medical information, regulatory information and submissions, and connected R&D data workflows.