CMIC Gains More Efficient Operations Using Oracle Argus

In the dynamic landscape of pharmaceutical safety, regulatory changes necessitate a robust and adaptable safety information management system. The pharmaceutical industry must adhere to evolving legal requirements and ensure the timely reporting of safety information to regulatory authorities.

CMIC, serving as an in-country clinical caretaker (ICCC) for international pharmaceutical companies entering the Japanese market, faces the challenge of reporting adverse events both locally and internationally. Seeking a reliable solution that aligns with local regulatory demands, CMIC implemented a multitenant database service in conjunction with Oracle Argus Safety for its clinical trial projects. This strategic move not only facilitated compliance with reporting requirements in Japan but also streamlined reporting obligations in the United States and Europe.

Access the case study below to see how the adoption of Oracle Argus enabled CMIC to digitize safety information management, ensuring prompt, efficient, and automated registration of safety data in a shared database, thereby enhancing the efficiency and accuracy of its drug safety operations.