Medical Research Collaborating Center Selects Medidata to Meet Global Regulatory Requirements During Clinical Trials
January 09 2018 - 8:30AM
Business Wire
One of the Leading Research Centers in South
Korea Leverages the Medidata Clinical Cloud®
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.”
About Medidata
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.
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