FDA Selects LifeSphere MultiVigilance, Medical Information, and Product Complaints as Components of Their New Integrated Safety Platform
MIAMI, FL. November 27, 2018 – The U.S. Food and Drug Administration (FDA) has selected Booz Allen Hamilton to support development, modernization, and enhancement of the FDA Adverse Event Reporting System (FAERS). As part of this work, the Agency will deploy ArisGlobal’s LifeSphere MultiVigilance (LSMV) platform to replace part of its current pharmacovigilance system that will intake, triage and process safety reports and make them available for review and analysis. LSMV will deliver the assured compliance, configurability, and flexibility needed to meet its growing responsibilities for protecting public health and safety. ArisGlobal’s LifeSphere Product Complaints and Medical Information will provide end-to-end processing of product quality defect reports, as well as tracking and responding efficiently to inquiries.
LSMV 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, substantially reducing manual effort. This new platform will be transformative for FDA in its ability to automate process, incorporate latest safety data standards and improve productivity resulting in reviewers to focus on public health and patient safety.
“Booz Allen is proud to support the FDA’s mission to protect public health by strengthening the Agency’s pre- and post-market surveillance operations. Our multidisciplinary team of drug safety domain experts and technologists will be responsible for providing the FDA an integrated and modernized suite of capabilities to protect consumers from unsafe and/or ineffective products.,” said Sean Chaffee, Booz Allen Hamilton FAERS Program Lead. “This transformational work will fundamentally improve health outcomes and positively impact mission performance.”
“We are delighted that our recently launched unified platform for drug safety, medical information and product quality complaints has been selected by FDA.” said Sankesh Abbhi, President and CEO, ArisGlobal. “Complementing the platform, our Regulatory Authority Standard Practices (RASP) initiative allows us to fully understand the needs and expectations of the regulatory health authorities. With the addition of the FDA, nine major authorities now rely on ArisGlobal solutions to protect public health.”
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ArisGlobal is transforming the way today’s most successful Life Sciences companies develop breakthroughs and bring new products to market. Our end-to-end drug development technology platform, LifeSphere®, integrates our proprietary Nava® cognitive computing engine to automate all core functions of the drug development lifecycle. Designed with deep expertise and a long-term perspective that spans more than 30 years, LifeSphere® is a unified platform that boosts efficiency, ensures compliance, delivers actionable insights, and lowers total cost of ownership through multi-tenant SaaS architecture.