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 the 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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About dMed Biopharmaceutical Co., Ltd (dMed, http://www.dmedglobal.com/), a clinical development services and solutions provider based in China that partners with both local and global pharmaceutical, biotech and medical device companies, is now an Argus Safety Business Process Service (BPS) partner for deployment of latest Argus multi-tenant bilingual system. Its services include scientific, strategic, regulatory and quality assurance related consultation for clinical development and product registration; clinical trial design and execution; clinical data management, biostatistics and programming, medical writing, pharmacovigilance and risk management; and clinical trial quality assurance and inspection readiness.
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