Satoko Inoue

Satoko Inoue has nearly 20 years of experience in the medical device and clinical space. Satoko joined Vorpal in 2020, serving as a specialist on the Clinical Affairs team where she is engaged in various regulatory application work such as clinical research, CER and PMDA consultation to align with PMDA on clinical program designs. Her experience with MCRA Japan includes work on diabetes prediction program devices, software as medical device products, as well as various neurological and surgical products. As part of this work, Satoko helps manage the clinical portions of PMDA submissions, good clinical practice (GCP) audits and post-marketing surveillance (PMS) studies. 

Satoko began her post-university career working for a medical distributor focused on cardiovascular products, including pacemakers, stents and catheter products. She then transitioned to a clinical research associate (CRA) role at EPS, one of Japan’s largest domestic clinical research organizations, where she worked for nearly a decade. At EPS, Satoko led several clinical studies for pharmaceutical products across a wide range of therapy areas and indications including diabetes, hypertension, analgesia and oncology. She then moved to the Public Health Research Center where she managed clinical research for the next six years, leading clinical protocol development for numerous studies, managed committees and ethics meetings, developed a SOP system, and managed the CRO and site coordination. Satoko holds a Bachelor of Science in biology from Kitasato University, where her studies were focused on genetics, which included research in gene identification for gastric cancer.