NEW YORK & SEOUL, South Korea--(BUSINESS WIRE)--
Medidata (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.”
Medidata is reinventing global drug and medical device development by creating the industry's leading cloud-based solutions for clinical research. Through our advanced applications and intelligent data analytics, Medidata helps advance the scientific goals of life sciences customers worldwide, including over 950 global pharmaceutical companies, biotech, diagnostic and device firms, leading academic medical centers, and contract research organizations.
The Medidata Clinical Cloud® brings a new level of quality and efficiency to clinical trials that empower our customers to make more informed decisions earlier and faster. Our unparalleled clinical trial data assets provide deep insights that pave the way for future growth. The Medidata Clinical Cloud is the primary technology solution powering clinical trials for 18 of the world's top 25 global pharmaceutical companies and is used by 18 of the top 25 medical device developers—from study design and planning through execution, management and reporting.
1 The Clinical Data Interchange Standards Consortium (CDISC) is an international, non-profit organization that develops and supports global data standards for clinical research.