FDA Selects LifeSphere MultiVigilance, Medical Information, and Product Complaints as Components of Their New Integrated Safety Platform
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.”
Learn more: LifeSphere MultiVigilance
Learn more: LifeSphere Medical Information
Learn more: LifeSphere Product Complaints