The FDA Modernizes Pharmacovigilance with LifeSphere MultiVigilance

The FDA’s next generation FAERS II system uses ArisGlobal’s industry-leading safety platform to automate intake, triage, and processing, improving regulatory processes and data quality. 

A Modern Pharmacovigilance Solution Delivered by ArisGlobal

Building a better, next generation adverse event reporting system is a cornerstone to the FDA’s Technology Modernization Action Plan and LifeSphere MultiVigilance is key to that solution.

ArisGlobal has been a trusted technology provider for the FDA since 2015, most recently assisting with the migration and mapping of over 3 terabytes of data, including 1.1 terabytes of safety data, 23 million case reports, and 76 million documents. As part of FAERS II, LifeSphere MultiVigilance is expected to handle more than 3 million safety data transactions per year.

The Next-Generation Safety System of the FDA and Other Leading Regulators

Built with the Industry, for the Industry

For over 30 years, ArisGlobal has partnered with leading pharmaceutical companies and regulatory agencies to identify innovative ways to solve pharmacovigilance challenges.  

LifeSphere MultiVigilance is the result of close coordination with top global life sciences organizations. Together with our partners, we’ve collaborated on a “best practice” out-of-the-box configuration, developed, tested and refined in real-world settings.


Delivering Real Results to a Global Client Base



Global Colaboration

80% of the top 50 pharma companies are our clients



Efficiency Gains

80% potential efficiency gains driven by our Nava cognitive computing engine



Cost Savings

30% immediate cost savings potential via our advanced automation capabilities




100% compliance with all present and upcoming regulatory standards

Artificial Intelligence and Robotic Process Automation at Work

LifeSphere MultiVigilance is the next-generation safety system from ArisGlobal. It combines artificial intelligence (AI) with robotic process automation (RPA) to help organizations streamline case processing and medical review, the platform is the most comprehensive and innovative end-to-end automated safety solution in the market. 

This new platform is transformative for the FDA in its ability to automate key processes, incorporate the latest safety data standards and improve productivity, allowing reviewers to focus on public health and patient safety. Pharmacovigilance is evolving. We’ll help you stay ahead.

This transformational work will fundamentally improve health outcomes and positively impact mission performance.”

Sean Chaffee

Booz Allen Hamilton, FAERS Program Lead

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