Pharmaceuticals and Medical Devices Agency (PMDA)
An independent agency managed by the Ministry of Health, Labour and Welfare. The institution provides guidance and oversight for the entire system that ensures the quality, effectiveness, and safety of drugs and medical devices, from prior to the start of clinical trials through approval, including the management of the approval process. It also collects, analyzes, and publishes information relating to the safety of drugs and medical devices after commercial sale begins.
 Around 10 million yen per trial
As of October 4, 2019, according to Fujitsu’s own investigations.
 SDTM guidelines
Guidelines for those generating SDTM data (https://www.cdisc.org/)
 Data collected with EDC systems from other companies and data collected by outside institutions that conduct clinical tests
Requires the deployment of tsClinical Metadata. In addition, this system does not support all products from other companies. For more information on supported systems, please see the product website.
Fujitsu is the leading Japanese information and communication technology (ICT) company, offering a full range of technology products, solutions, and services. Approximately 132,000 Fujitsu people support customers in more than 100 countries. We use our experience and the power of ICT to shape the future of society with our customers. Fujitsu Limited (TSE: 6702) reported consolidated revenues of 4.0 trillion yen (US $36 billion) for the fiscal year ended March 31, 2019. For more information, please see www.fujitsu.com.
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Date: 30 October, 2019
Company: Fujitsu Limited