MultiVigilance
Automated end-to-end case processing and management for drug safety with AI-powered compliance and global harmonization.
Overview
MultiVigilance, part of ArisGlobal's LifeSphere platform, is an end-to-end automated drug safety system designed for pharmacovigilance teams in pharmaceutical and biopharmaceutical organisations. Powered by NavaX, it supports touchless case processing from intake through to submission, and is built to help safety teams manage case volumes at scale while maintaining compliance with global and regional regulations.
The system is deployed as a cloud-based, multitenant SaaS solution and is in active use across hundreds of organisations globally, including leading biopharma firms, CROs, and government health authorities such as the FDA, Health Canada, and NMPA. ArisGlobal draws on over 30 years of safety expertise in the development and ongoing maintenance of the platform.
Core Capabilities
- End-to-end touchless case processing, reducing manual intervention across the full case lifecycle from intake to submission.
- A single, harmonised global safety database built on an open architecture, supporting unified end-to-end workflows across international operations.
- Cloud-based, multitenant infrastructure that scales to accommodate rising case volumes as organisations grow.
- AI-powered translation integrated directly into the platform for multilingual case processing, supporting global pharmacovigilance operations.
- Out-of-the-box capabilities developed in collaboration with leading biopharma firms and available for immediate use upon deployment.
Compliance Support
- Ongoing cloud updates to maintain alignment with the latest global and regional regulatory requirements.
- Support for FDA E2B(R3) requirements and other international regulatory standards.
- Consistent, up-to-date compliance coverage described as the most robust available within the platform's market positioning.
Automation and Efficiency
- Automation spans the entire case processing workflow, from initial case intake through narrative generation to regulatory submission.
- Designed to deliver measurable efficiency gains by reducing the need for manual case handling steps.
- NavaX automation engine underpins the platform's touchless processing capabilities, which are described as currently in production rather than in development.
MultiVigilance is deployed as a secure, cloud-based SaaS solution with open integration architecture, enabling connectivity with other systems within a life sciences organisation's technology environment. ArisGlobal is headquartered in the United States and maintains regional offices in Europe, India, Japan, and China, supporting its global customer base of more than 220 life sciences companies and regulatory bodies.


