IL-MINDBREEZE
16.1.2020 14:02:12 CET | Business Wire | Press release
Mindbreeze, a leading provider of appliances and cloud services for knowledge management, and Booz Allen Hamilton, a leader in management and technology consulting, are collaborating with the Food and Drug Administration (FDA) to deliver enterprise search capabilities for the Center for Drug Evaluation and Research (CDER) regulatory review community. The intelligent Mindbreeze InSpire solution was successfully launched in October to provide broad search capabilities for critical review information and a decision-support mechanism to aid the review process for the Center’s regulated products.
“We are proud to partner with Mindbreeze and the FDA to deliver leading-edge search capabilities to support the Agency’s important public health mission,” said Dr. Roman Salasznyk, Vice President at Booz Allen. “Our team of technologists and enterprise search experts are committed to transform FDA’s human drug review process leveraging enabling technologies that ultimately help bring live-saving treatments to market with greater speed and efficiency.”
Mindbreeze InSpire supports the FDA staff in efficiently managing the drug review process with a solution that compiles more than 150 million submission documents, reviews, and communications into a single user interface and makes them available as a consolidated knowledge base. The solution combines the latest technological developments such as machine learning, natural language processing, and AI-supported search functions in an appliance that is easy to use and implement.
“Our partner Booz Allen Hamilton has built up a wealth of expertise about Mindbreeze in recent years. Their implementation skills and commitment make them the perfect partner for us and our efforts to accelerate future large-scale projects across the US government and life sciences sectors,” adds Daniel Fallmann, founder and CEO of Mindbreeze.
About Mindbreeze
Mindbreeze is a leading international provider of appliances and cloud services for enterprise search, applied artificial intelligence, and knowledge management. Mindbreeze’s global network of partners makes it possible to serve customers across time zones anywhere in the world.
You can find more information at www.mindbreeze.com or follow us on LinkedIn and Twitter @Mindbreeze.
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