Kowa Company Simplifies the Process for Global Pharmacovigilance Compliance with Oracle Argus Safety Cloud Service


Applied Clinical Trials

 REDWOOD SHORES, CA -- July 2015 –Kowa Company Ltd., a Japanese pharmaceutical company with affiliates in North America, Asia and Europe, has migrated to Oracle Argus Cloud Service Global and Oracle Argus Cloud Japan. As the company sets out to execute on an aggressive international growth plan, Oracle Argus Cloud Service Global and Oracle Argus Cloud Japan will help Kowa manage compliance with the increasingly complex regulatory requirements and reduce its overall pharmacovigilance IT spend.

Oracle Health Sciences Consulting assisted in the migration, leveraging reusable assets built from past engagements, and from the experience of their global, multilingual and multicultural team members.

Kowa is taking advantage of Oracle Argus Cloud Service’s capabilities to support compliance with regulatory requirements in Japan, North and Europe and expects to be better prepared to address international and emerging compliance reporting requirements, such as E2B (R3).  By using Oracle Argus Cloud Service to consolidate its safety infrastructure into a single, scalable, global database, Kowa can also continue to reduce its IT complexity and maintenance requirements while establishing the pharmaconvigilance system needed for its business expansion into new markets. 

“As we continue to expand our company and products globally, we need a safety platform that supports our global pharmacovigilance user base with the highest standards of compliance reporting, reliability and performance in the countries where we are marketing the products,” said Kazuhiro Aizawa, Director of Pharmacovigilance Dept., Kowa Co., Ltd.  “Oracle Argus Cloud Service has helped us to meet this goal, while enabling us to reduce our total cost of ownership.”

 Kowa benefits from Oracle Argus Cloud Service’s 24 X 7 operational support, high availability and its support for compliance with industry standards including ISO 20000-1, SSAE – 16 and HIPAA Title 21 CFR part 11.

 “The networked, global nature of the life sciences industry has made safety reporting more complex than ever,” said Steve Rosenberg, senior vice president and general manager, Oracle Health Sciences. “Oracle Argus Cloud Service helps life sciences organizations across the spectrum reduce risk and cut total cost of IT ownership, while offering outstanding security, scalability and performance.”


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