July 11, 2022
CMIC Co., Ltd.

CMIC adopts the Oracle Argus Cloud Service and launches the first multi-tenant database service among Japanese CROs

CMIC Co., Ltd. (headquarters: Minato-ku, Tokyo; President and Representative Director: Toru Fujieda) has adopted the Oracle Argus Cloud Service, a cloud service associated with Oracle Corporation’s comprehensive pharmacovigilance (PV) platform (Oracle Argus Safety), and launched a multi-tenant database service that allows CMIC’s manufacturer clients to lease a shared database.

CMIC provides services as an in-country clinical caretaker (ICCC) for overseas pharmaceutical companies aiming to enter the Japanese market. As part of these services, CMIC reports adverse events that occur domestically and overseas to the Pharmaceuticals and Medical Devices Agency (PMDA) and overseas corporate clients. Due to revisions to pharmaceutical laws in various countries, systems for managing safety information in the pharmaceutical industry are constantly changing. To ensure compliance with laws and regulations of various countries, CMIC adopted Oracle Argus Safety. Oracle Argus Safety is a global safety database used by many customers, including major Japanese and overseas pharmaceutical companies. CMIC decided to adopt Oracle Argus Safety because of its reputation for quality and many customers’ desire to have access to it.

In additional to apply Oracle Argus Safety to the clinical trial projects CMIC manage, CMIC  also launched a multi-tenant database service that enables clinical trial sponsors to lease a shared database. This service is to support companies that have a small number of annual cases and gain little cost advantage from installing Oracle Argus Safety in-house or that are planning to report to regulators around the world in the future. The lead time to set this up is short.Also, users do not have to worry about their IT resources as CMIC’s system engineers take care of the administration of Oracle Argus Safety.

CMIC provides not only services related to individual case reporting, but also comprehensive PV services that cover a wide range of activities from clinical trials to post-marketing operations. Currently, CMIC is the only company in Japan that offers a shared database service based on the multi-tenancy capability of Oracle Argus Safety.

About CMIC Group

CMIC Group was founded in 1992 as the first Contract Research Organization (CRO) in Japan. Today CMIC Group is the largest clinical CRO in Japan with a global footprint, providing comprehensive services in drug development, clinical site management, manufacturing, regulatory consulting and contract sales & marketing solutions. We can help pharmaceutical, biotech and medical device companies to enter the Japanese market, to conduct clinical trials in Asia, or to bridge drug development and manufacturing needs in the US, Europe, Japan and broader Asia. CMIC Group has over 7,000 employees and 24 sites globally. For more information about CMIC Group and services, please visit the CMIC website.

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