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Oracle Provides Health Solutions for Drug Adverse Effect Management and Safety Reporting to Celltrion

Google 우선 소스Published2017.09.29 11:19
Oracle Health Solutions Regulatory Report on Safety and Efficacy, Key Factors for Biosimilar Success
Supporting the client to smoothly carry out the process
Oracle announced that it is supplying its health solutions, Argus and Empirica Signal, to support Celltrion in managing drug side effects and enhancing patient safety. With the adoption of Oracle's solutions, Celltrion is now able to launch treatments for chronic diseases and biotech therapies at more reasonable prices.
With predictions that approximately $100 billion (about 110 trillion KRW) in global healthcare costs will be saved through biosimilars by the end of 2020, the number of biosimilar manufacturers is increasing. Furthermore, regulatory agencies such as the U.S. Food and Drug Administration (FDA) are supporting the rapid launch of biosimilars. Accordingly, Celltrion has adopted Oracle’s Health Sciences technology to streamline regulatory reporting processes related to safety and efficacy, which are considered key to the success of biosimilars.
Through the adoption of Oracle Health Sciences' Argus Enterprise Edition, Celltrion has not only improved its management of drug side effects but also significantly reduced IT costs. With the Argus solution, Celltrion is able to make rapid and accurate decisions regarding safety issues and is provided with a comprehensive platform in which crisis management functions are integrated into the core development process. In addition, Oracle’s Empirica Signal, based on a data mining environment, enables immediate detection of abnormal signals related to drug safety through automatically generated adverse event reports, immediate identification of abnormal patterns, and immediate visual verification.
Steve Rosenberg, General Manager at Oracle Health Sciences, said, “The number of biosimilar manufacturers is increasing, and the biopharmaceutical market is rapidly innovating. Oracle Health Sciences is also continuing to innovate to provide solutions that meet the changing needs of customers in a changing environment.” He added, “Celltrion is a prime example of an innovative biotech company that constantly strives to improve people’s quality of life.”
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