Clinical trial in Japan
HOME > Clinical trials > GCP Audit Service

GCP Audit Service

GCP Audit for Medical Device and Pharmaceuticals

JMDC provides auditing services for pharmaceuticals and medical device clinical trials, as an independent organization.
The compliance status will be evaluated in terms of clinical trial facilities, document control, monitoring activities, and personnel. All deficiencies identified during the GCP audits will be noted in the audit report with gap analysis and proposed corrective actions.
We can develop and deliver a complete auditing project for you or simply help with specific elements.


The services include following items.


1. Vendor Qulification GCP Audits


2. GCP Auditing of Investigators/Study Sites


3. Sponsor/Contract Research Organization GCP Audits


4. Institutional Review Board GCP Audits


JMDC also provides consultant services for GCP inspection by PMDA (Japanese authority).

GCP audit




********************************************************************

Please refer to our publication for more detailed information.

"The Japan Medical Device Market and Regulatory Report"

Tokyo time

Clinical Trials

▲ page top