Akira Soma is a Master principal solution consultant at Oracle Health Sciences Global Business Unit with over seven years’ experience in both clinical development and pharmacovigilance. He has over 15 years of experience working in the pharmaceutical industry both in Japan and the United States primarily focused on clinical data management and IT. Prior to joining Oracle, he was a manager of data management/IT at Mitsubishi Tanabe Pharma Development America and the work he had done included governing, developing SOPs/WIs, and implementing SDTM standards within the company. Akira Soma has been the chair of Japan CDISC Coordinating Committee (J3C) since 2021, involved with the Japan CDISC User Group SDTM team for more than 10 years, and had been active in a couple of PhUSE CSS Working Groups.