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MOSS Institute Co., Ltd. announced that its electronic data capture (EDC) system CLASSY fully complies with the U.S. Food and Drug Administration’s (FDA) Part 11 of Title 21 of the Code of Federal Regulations
Tokyo, Japan and New York, NY – July 5, 2005 – MOSS Institute Co., Ltd. announced that its electronic data capture (EDC) system CLASSY fully complies with the U.S. Food and Drug Administration's (FDA) Part 11 of Title 21 of the Code of Federal Regulations. (The 21 CFR Part 11 regulations, which were distributed by the FDA in M arch 1997, established requirements for adopting electronic data records and electronic signatures, which was replacing traditional paper-based documentations.) CLASSY EDC's compliance with 21 CFR Part 11 requirements further assures MOSS clients that MOSS Institute's electronic data management is both reliable and secure.
MOSS Institute is a Tokyo-based, publicly held company established in 1995, which provides a variety of services to support clinical trials. Currently, MOSS Institute is implementing CLASSY in its subsidiary Union Clinical Research Services Co., Ltd. in China. As part of its current strategy to expand its business to international markets, MOSS Institute has retained Giuliani Partners LLC and GNYHA Consulting.
"MOSS Institute is committed to complying, or when appropriate, exceeding the standards and regulations that it and its clients are subject to. Meeting 21 CFR Part 11 requirements will further enable it to meet the needs of its international clients," said Ichiro Hayashi, President and CEO of MOSS Institute.
Yamatake Corporation has audited MOSS Institute's CLASSY EDC for compliance with 21 CFR Part 11 and will publish its final evaluation in July 2005. In April of this year, the Japanese Ministry of Health, Labour and Welfare issued The Guidelines for Utilizing Electronic Data Records and Signatures for Applications for New Drug Approvals, creating additional regulations for pharmaceutical companies to protect patient information. MOSS Institute's compliance with both of these regulations, coupled with its well-established presence in China, demonstrates MOSS Institute's commitment to growing outside of Japan and adhering to both global and local standards.
About MOSS Institute Co., Ltd.
Established in 1995, MOSS Institute Company, Ltd. is a company based in Tokyo, Japan that specializes in registration service, randomization service, data management service, marketing support service, and privacy consulting service for the health care industry. (www.moss.co.jp/english/)
About Yamatake Corporation
Originally established in 1906, Yamatake Corporation provides a variety of management consultation services in the health care industry. Yamatake's consultations include computerized system validation, and assessment on regulatory laws, with a perspective on global trends. Yamatake has conducted more than 100 assessments on the computerized systems. Yamatake also has a global alliance with SEC Associates, Inc.
, a U.S.-based corporation.
About Union Clinical Research Services
Established as a joint venture between MOSS Institute Co., Ltd. and Beijing Union Medical & Pharmaceutical Corporation, a subsidiary of Peking Union Medical College, China's most prestigious medical institution, Union Clinical Research Services conducts clinical trials for domestic and overseas pharmaceutical companies, while also providing management consultation service. (http://www.moss.co.jp/ucrs/english/)