Akira Soma is a Solution Director at Oracle Life Sciences with over nine years of experience in clinical development and pharmacovigilance. With a robust background spanning more than 15 years in the pharmaceutical industry across Japan and the United States, his expertise primarily lies in clinical data management and IT. Before joining Oracle, Akira was the Manager of Data Management/IT at Mitsubishi Tanabe Pharma Development America, where he was responsible for governing, developing Standard Operating Procedures (SOPs) and Work Instructions (WIs), and implementing Study Data Tabulation Model (SDTM) standards within the company. Akira has been serving as the Chair of the Japan CDISC Coordinating Committee (J3C) since 2021 and has been involved with the Japan CDISC User Group SDTM team for over a decade. Additionally, he has actively participated in several PhUSE Computational Science Symposium (CSS) Working Groups.