The FDA Goes Live with LifeSphere MultiVigilance, Modernizing Pharmacovigilance Capabilities with FAERS II

ArisGlobal, a provider of life sciences software that automates core drug development with its end-to-end drug development technology platform LifeSphere®, announced the go-live of the FDA Adverse Event Reporting System (FAERS II), an electronic safety reporting platform, powered by LifeSphere MultiVigilance. The successful go-live marks a key milestone in the FDA's Technology Modernization Action Plan, and the culmination of its efforts to adopt a cutting-edge platform to automate the intake and processing of adverse event reports.

Designated a modernization priority by the United States Department of Health and Human Services, FAERS II is a mission critical platform for the FDA's Centers of Drug and Biologic Evaluation and Research (CDER/CBER), providing a modern, all-in-one solution for collection, triage and processing of adverse event reports. With safety case volumes growing amid a global public health crisis, the platform will leverage the flagship safety product of ArisGlobal's LifeSphere R&D technology suite, LifeSphere MultiVigilance, to increase efficiency and improve data quality. A proven and scalable solution already adopted by many of the largest global biopharmaceutical companies, LifeSphere MultiVigilance is the only safety system in production that uses AI and machine learning to automate the end-to-end processing of adverse event reports in the industry for market authorization holders.

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. Moving forward, all ICSRs (Individual Case Safety Reports) received by the FDA will be processed using LifeSphere MultiVigilance and the system is expected to handle more than 3 million safety data transactions per year.

"We would like to congratulate the FDA on achieving a key milestone in their digital transformation journey," said Sankesh Abbhi, President & CEO of ArisGlobal. "We are grateful for the opportunity to help bring the FAERS II project to life with the successful implementation of LifeSphere MultiVigilance. Our partnership has yielded a truly innovative approach to safety case management, which we hope enables the FDA to achieve its goal of making safety data accessible and transparent."