Shionogi developed AI-SAS, a product that semiautomates programming tasks for clinical trials, achieving a 33% reduction in work time. Our achievement, including AI-SAS, won first place in the Innovative Problem Solver category at the 2024 SAS Customer Recognition Awards and is also provided externally as part of our social contribution efforts. In July 2024, the Food and Drug Administration (FDA) issued a guideline enabling the use of real-world evidence (RWE) in drug approval applications. Shionogi expanded AI-SAS to develop RWE incorporating generative AI technology. The semiautomation process covers protocol, SAP, and spec creation, considering FDA guideline compliance, and can achieve a 50% reduction in work time. This product is also planned for external provision.
Presenting Company: Shionogi & Co., Ltd.
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