Oracle Health Sciences Collaborates with dMed in China to Enhance Pharmacovigilance Management

Press Release 

Oracle Health Sciences Collaborates with dMed in China to Enhance Pharmacovigilance Management with Oracle Health Sciences Argus Safety

Suzhou, China—Oct 27, 2017

Today Oracle announced that is collaborating with dMed in China as rapidly emerging local Chinese biopharma companies look to meet growing regulatory compliance and safety management requirements but do not have the resources, systems and skills in-house to do so.

There is an increase in clinical trials in China, deepening regulatory reform at CFDA, and China’s new membership at ICH. All of these changes have heightened the importance of global alignment on clinical development and post approval responsibilities. One of the areas lagging is drug safety and pharmacovigilance. This has resulted in the strong need for a reliable drug safety database that helps meet international safety standards.

“This is why dMed decided to work with Oracle Health Sciences,” said Dr. Lingshi Tan, Chairman and CEO, dMed Biopharmaceutical Co., Ltd. “The Oracle Argus Safety system enables our Pharmacovigilance experts to provide comprehensive case management and safety reporting services. The ability of accessing a reliable drug safety database helps customers meet international safety standards and make better safety decisions.”

“We are pleased to announce our collaboration with dMed Biopharmaceutical Co., Ltd as an Argus Safety customer in China. dMed has right drug safety surveillance and pharmacovigilance professionals who can make best use of our system to support product safety monitoring in compliance with local and global regulatory requirements,” said Mr. Steve Rosenberg, senior vice president and general manager of Oracle Health Sciences. “We believe there will be fantastic synergy between dMed’s in-depth knowledge in pharmacovigilance and Oracle’s comprehensive pharmacovigilance platform.”

By collaborating with Oracle Health Sciences on business process services, dMed aims to help its clients to optimize global compliance and integrate risk management into key processes. Local sponsors such as Hua Medicine, Zai Lab and others are leveraging these services and the Argus platform to meet their Safety and compliance requirements. 

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Valerie Beaudett

Oracle

+1.650.400.7833

valerie.beaudett@oracle.com