Akiko Shibuya

QA Auditor

Akiko has nearly 20 years of  experience  in a series of drug development-related activities, including clinical monitoring, project management, PMDA review management, and GCP inspection management in the clinical development divisions at a pharmaceutical company. Furthermore,  she has experiences in supervising PV and PMS divisions. Based on her various experiences, she proposes the most appropriate audit plan that meets the client’s needs, taking into consideration the Japan’s regulatory situation.

Micron is an iCRO (imaging CRO) with general clinical CRO services. Our audit service covers not only our iCRO services, but also respective therapeutic areas in which our clinical CRO section has contracts.  In addition to J-GCP studies (Phase I-III for clinical developments of pharmaceuticals and medical devices), we also support non-interventional/observational studies which are conducted in accordance with Japan’s unique regulations.

All of Micron’s auditors have more than 5 years of auditing experience.  We are also proud to have auditors  who are qualified as “GCP experts,” and are recognized by the Japanese Society for Clinical Trial Research as persons who can be in a supervising position. Still not satisfied, Micron is striving to further improve our audit team’s expertise.  As Micron has both English and Japanese versions of the audit procedure manual, we can respond promptly to any requests. Akiko and her team are looking forward to help you to achieve your study goals.