NRI Commissioned to Develop a Data Management System for Eisai's
— A data management package for pharmaceutical research and development
utilizing Waters NuGenesis SDMS —
May 19, 2004
Nomura Research Institute, Ltd.
Nomura Research Institute, Ltd. (NRI: Tokyo; Akihisa Fujinuma, President, CEO & COO) has been commissioned by Eisai Co., Ltd. (Eisai: Tokyo; Haruo Naito, President & CEO) to develop and launch by the end of fiscal 2004, a pharmaceutical research and development data management system for Eisai's non-clinical area of activities. In order to provide a data management system in compliance with the relevant laws and regulations, the Waters NuGenesis Scientific Data Management System (SDMS), a data management package software for pharmaceutical research and development marketed by NRI, will be utilized. This will be the major introduction in Japan of a data management system utilizing the Waters NuGenesis SDMS into a research institution with more than 100 users.
Under the intensified global competition in the pharmaceutical industry, the speedy introduction of valuable products to the market has become an ever more important issue in terms of R&D; with the digitization of research data being one of the effective measures. Further, in order to comply with 21 CFR Part 11, the U.S. Food and Drug Administration's (FDA) rule regulating electronic records and electronic signatures (hereinafter “Part 11”), the industry requires not only reliability, authenticity and traceability of electronic data, but also security through the implementation of automated audit trails.
Furthermore, regulatory authorities are moving forward to establish an environment that will promote electronic data utilization. Such steps include the FDA's announcement in September 2003 of a guidance regarding Part 11 which recommends the implementation of a risk based approach, as well as an announcement last year by the Japanese Ministry of Health, Labor and Welfare of the “Guidance for Use of Electromagnetic Records and Electronic Signatures in Applications for Approval and Permission for Pharmaceutical Products (draft guidance).”
Under such circumstances, Eisai's R&D sector considers it essential to promote the digitization in tripartite research and development—in Japan, the United States and Europe. Eisai is actively promoting the digitization of research data by preparing for eCTDs (electronic common technical documents) and developing electronic data management for application materials that complies with Part 11.
Since last summer, NRI has been a fully-fledged participant in the pharmaceutical research and development data management field. And since October 2003, NRI has been verifying the effectiveness of the Waters NuGenesis SDMS as an electronic management tool for the analysis of Eisai's research data.
As a result, we have confirmed that the Waters NuGenesis SDMS can facilitate the electronic management of research data in the field of non-clinical research and is efficacious for research activities. The full-scale project was launched in May 2004, with March 2005 set as the target date for the system becoming fully operational.
Based on the know-how learned from this project, in the future NRI will develop electronic data management solutions utilizing the Waters NuGenesis SDMS for a wide range of applications in the pharmaceutical industry.
NRI exhibits the Waters NuGenesis SDMS at Interphex Japan 2004 Pharmaceutical IT Solution Expo, the largest pharmaceutical industry trade fair in Asia, from May 19 to 21.
About Waters NuGenesis SDMS
The Waters NuGenesis Scientific Data Management System (SDMS) significantly improves the value of information and provides measurable productivity gains. With thousands of users in hundreds of laboratories around the world, Waters NuGenesis SDMS is the market leader in its category. Waters NuGenesis SDMS provides a complete solution for IT, laboratory, regulatory, and business management — enabling customers to achieve their business objectives, meet regulatory requirements, and integrate with their existing IT infrastructure.
Waters NuGenesis SDMS products provide a foundation for scientific data preservation and for integrating the collaborative flow of information throughout the organization. Waters NuGenesis technologies play a critical role in managing the complete life cycle of critical scientific information, allowing skilled researchers more time to focus on analysis, interpretation and decision-making.
About Waters Corporation
Waters Corporation holds worldwide leading positions in three complementary analytical technologies — high performance liquid chromatography (HPLC), mass spectrometry (MS) and thermal analysis (TA). These markets account for $4.4 billion of the overall $20 billion analytical instrumentation market.
Waters, NuGenesis, and NuGenesis SDMS are trademarks of Waters Corporation.
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