CMIC, the largest contract research organization in Japan, provides effective safety information management with Oracle Argus database.
“With the help of Oracle’s integrated, end-to-end pharmacovigilance solutions, we can provide services from clinical trials to post-marketing operations.”
Safety information management in the pharmaceutical industry is constantly changing due to frequent revisions of laws in each country. A reliable database is essential for drug safety operations in order to meet legal requirements and ensure timely reporting to regulatory authorities. Digitalization is also progressing so that collected safety information can be promptly, efficiently, and automatically registered in a safety database.
CMIC provides services as an in-country clinical caretaker (ICCC) for overseas pharmaceutical companies seeking to enter the Japanese market. When providing services as an ICCC, CMIC must report adverse events occurring in Japan and overseas to the Pharmaceuticals and Medical Devices Agency and also to overseas client companies. That is why CMIC sought a reliable reporting solution that would meet local regulatory requirements.
We adopted Oracle Argus because it’s absolutely essential that we have reliable reporting that meets local regulatory requirements.
Why CMIC chose Oracle
CMIC must report adverse events, such as an undesired effect of a drug or other type of treatment, that occurs in Japan or overseas to the Pharmaceuticals and Medical Devices Agency and overseas client companies.
Reliable reporting that meets the local regulatory requirements is absolutely necessary. This is one of the main reasons why CMIC selected Oracle Argus Safety, a global safety database that has been proven globally, and has an established reputation for quality and security.
CMIC launched multitenant database service along with Oracle Argus Safety for its clinical trial projects, because many of CMIC’s customers wanted to lease a shared database.
After CMIC adopted Oracle Argus, it was able to meet not only reporting requirements in Japan, but also in the United States and Europe.
CMIC is the only company in Japan that offers a shared database service based on the multitenant capability of Oracle Argus. The tenant of each company was developed based on basic settings established by CMIC and greatly decreased the lead time from contract to the start of operation. In addition, users don’t worry about IT resources because CMIC takes care of the administration.
Because of its partnership with Oracle, CMIC offers both global customers considering market entry to Japan and local customers planning to enter the global market effective and efficient safety case management through a single database, compliant with global regulations. Supported by Oracle’s fully integrated platform of end-to-end pharmacovigilance solutions, CMIC can provide comprehensive services, from clinical trials to post-marketing operations.
About the customer
CMIC Group was founded in 1992 as the first contract research organization in Japan. Since then, it has become the country’s largest CRO with a global footprint, providing comprehensive services.