One of the Leading Research Centers in South Korea Leverages the Medidata Clinical Cloud®.

NEW YORK & SEOUL, South Korea — (Medidata 
(NASDAQ:MDSO), the leading global provider of cloud-based technology and data analytics for clinical research, today announced that the Medical Research Collaborating Center (MRCC), one of the leading research centers of biomedical science in South Korea, has selected Medidata Rave® to accelerate the overall regulatory data submission process during clinical trials. MRCC, which is under the Biomedical Research Institute of Seoul National University Hospital (SNUH), will leverage the Medidata Clinical Cloud to facilitate clinical trials with its partner pharmaceutical companies.

MRCC was established as a division in the Department of Education and Research for SNUH, serving as a coordinating center for large scale multicenter clinical trials and epidemiologic studies. By integrating Medidata Rave, the world’s leading solution for capturing, managing and reporting patient data, and complying with international standards such as CDISC1, MRCC aims to further standardize data management and statistical analytics to meet global standards and regulatory submissions, including those by the FDA.

“By adopting Medidata’s solution, we plan to lead innovation in the field of life science research and strengthen our clinical research capabilities,” said professor Hyun-jae Kang, director of Medical Research Collaborating Center (MRCC).

Electronic data management systems that comply with global regulatory standards are necessary for new drug submissions. With Medidata Rave, MRCC expects to improve the process of data management and plans to make a transition from Clinical Data Acquisition Standards Harmonization (CDASH) to Study Data Tabulation Model (SDTM).

“We’re pleased to be facilitating new technology solutions for the Medical Research Collaborating Center of Seoul National University Hospital, one of the leading research centers of biomedical science in South Korea,” said Edwin Ng, vice president of field operations of APeJ, Medidata. "The effective management and collection of clinical trial data is necessary to meet regulatory standards, and accelerates the delivery of new solutions to patients around the world. We’re proud to be the comprehensive cloud platform selected by global pharmaceutical companies to not only meet their research goals, but exceed them.”



References

1 The Clinical Data Interchange Standards Consortium (CDISC) is an international, non-profit organization that develops and supports global data standards for clinical research.

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