Oracle Corporation Japan (Headquarters: Minato-ku, Tokyo; President: Toshimitsu Misawa) announced that ONO PHARMACEUTICAL CO., LTD. (Headquarters: Chuo-ku, Osaka; President and CEO: Gyo Sagara, “ONO”) implemented Oracle’s Clinical Trial Management System (CTMS) Cloud Service as an IT platform for clinical trials as part of ONO’s digital transformation (DX) strategy. The implementation of this system enables the centralized management of clinical trial information and monitoring activities globally and is expected to significantly reduce the system management workload compared to before implementation.
Under the corporate philosophy of “Dedicated to the Fight against Disease and Pain,” ONO aims to implement corporate transformation in the digital and IT fields, including renovating its IT infrastructure with an eye toward globalization and transformation of the drug discovery value chain, and achieving sustainable growth by promoting innovation and creating innovative new drugs.
The IT infrastructure of drug development plays an important role in promoting business efficiency and supplying the most consistent and up-to-date data in the DX strategy. Clinical trials continue to diversify, and the number of large-scale global clinical trials is expected to further increase in the future. Under such circumstances, there is a need to manage monitoring activities and clinical trial information in a more timely and efficient manner. Oracle’s CTMS can help improve the quality and efficiency of clinical trials by managing the progress of global clinical trials and integrating with other existing systems, and it can utilize data stored in internal systems to predict potential risks and improve the probability of trial success.
Oracle’s CTMS is a comprehensive and scalable integrated system that standardizes monitoring workflows and enhances operational efficiency by visualizing data in real-time. It allows for the implementation of detailed requirements using standard modules and accelerators (optional) for clinical trial information management, and it can seamlessly integrate with other systems through Application Programming Interface (APIs). Additionally, the optional Clinical Data Analytics enables real-time visualization and analysis of Key Performance Indicators (KPI) and Key Risk Indicators (KRI). It is the most widely used system in global clinical operations, with more than 60 domestic and international customers.
Due to differences in regulatory requirements in Japan and overseas, pharmaceutical companies have two CTMS, which need to manually adjust items and formats, and require many resources to manage them. As Oracle’s CTMS incorporates the Japanese requirements and can be utilized globally, clinical trials can be managed efficiently with one system, which has the advantage of reducing the system management workload and helping make accurate decisions quickly.
“ONO Pharmaceutical has embarked on a transformative journey in managing its global clinical trials, with a focus on efficiency and data-driven decision-making. By implementing Oracle’s comprehensive Clinical Trial Management System, we are now able to implement a cutting-edge solution that seamlessly integrates with its current systems. The solution provides ONO Pharmaceutical with streamlined trial operations and real-time data access across its diverse trials. We believe that this enhanced visibility is crucial for ONO Pharmaceutical to proactively identify potential risks in its clinical trials and to make informed strategic business decisions. Oracle’s CTMS is not just a tool but a partner in ONO Pharmaceutical’s journey towards innovative and effective clinical trial management,” said Seema Verma, executive vice president and general manager of Oracle Health & Life Sciences.
