Hiromi Hasegawa, RN, MS
Clinical Research Support Office, National Cancer Center Hospital East
Hiromi Hasegawa is a Chief Researcher at Clinical Research Support Office. Currently she work for some real-world data projects utilizing clinical research and new drug application in hospital. Her interests are research data quality as regulatory grade, and patient reported outcomes used in clinical settings.
She received an BS and MS in nursing and had worked as Registered Nurse in hospitals in Japan for several years, and then changed her carrier to clinical data management. She has worked for clinical data manage in academic research organization more than 15 years, especially in investigator-initiated trials for new drug applications in oncology. She has many experiences with CDISC standards, data quality, and data integrity. She also had worked with electronic data submission of new drug applications at the Pharmaceuticals and Medical Devices Agency (PMDA) from 2018 to 2021. This experience gave her deep understanding about regulatory guidance and administrative processes for new drug application and review related in electronic data submission.