Medytox to Further Expand Global Presence by Increasing Its Adoption of the Medidata Clinical Cloud®
May 15 2017 - 05:30PM
Business Wire
Global Biopharmaceutical Company to Become the
First in Korea to Adopt Medidata’s Risk-based Monitoring Solution
for Its Major Clinical Trials
Medytox Aims to Develop the Next Generation of
Biomedicine through Improved Data Quality via Global Standards
Medidata (NASDAQ: MDSO), the leading global provider of
cloud-based solutions and data analytics for clinical research,
announced today that Medytox, a global biopharmaceutical company
based in Korea, will expand its use of the Medidata Clinical Cloud®
for domestic and global clinical trials. Using Medidata’s
state-of-the-art strategic monitoring and mobile health (mHealth)
solutions, Medytox will effectively evaluate and monitor study risk
factors while pioneering patient-focused research practices—leading
to better, more nuanced clinical trial data and higher quality
R&D programs.
A leader in the botulinum toxin (commercially known as “Botox”)
sector, Medytox is increasingly extending its clinical trial
practices beyond Korea, adopting a number of global standards put
forth by such industry non-profits as TransCelerate, Clinical Data
Interchange Standards Consortium (CDISC) and Critical Path
Institute (C-Path). The biopharmaceutical has also been using
Medidata’s globally validated, unified solution for EDC, management
and reporting (Medidata Rave®) and trial randomization and supply
management (Medidata Balance®) since 2015. Now, by furthering its
use of Medidata’s technology platform, Medytox is improving the
quality of its clinical research programs by proactively addressing
study performance issues, streamlining workflows and ensuring the
safety of its patients.
“With our unique R&D capacity, Medytox is working to create
a new paradigm in the biopharmaceutical industry. In order for us
to deliver on our mission of creating happier, healthier lives for
patients, it is important that we apply advanced technology to our
R&D efforts and evolve our expertise beyond Korea,” said
Woo-Shun Lee, MD, head of medical at Medytox. “By integrating
Medidata’s solutions—which have a proven track record in the global
market—into our clinical trial practices, we hope to improve the
accuracy and quality of our clinical data while increasing the
efficiency of new drug development processes.”
Medytox will be the first company in Korea to adopt Medidata
TSDV® and Medidata SQM in pursuit of a risk-based monitoring
approach to its clinical trials. The biopharmaceutical company will
use the tools in tandem to improve the quality of its clinical
research data, tapping into TSDV to enhance its source document
verification (SDV) process and SQM to monitor and evaluate the
level of risk associated with data collected at each of its
clinical study sites. Additionally, Medytox will incorporate
Medidata’s electronic patient-reported outcomes (ePRO) solution
into a select number of its studies. Part of the Medidata Patient
Cloud®, Medidata ePRO replaces paper questionnaires and patient
diaries with a mobile application, allowing patients to easily
input health information—which is available to sponsors
immediately—on an ongoing basis.
Edwin Ng, the VP of field operations for Medidata APeJ, said,
“We are proud to strengthen our partnership with Medytox, a company
dedicated to making our world a better place with top-class R&D
expertise in the botulinum toxin area. By providing the Medytox
team with top-of-the-line technology and the tools to extract
real-time insight into study performance and data quality, we’re
excited to help further Medytox’s efforts of becoming a true global
leader in the biopharmaceutical space.”
Connect with Medidata
- Read our blog, Geeks Talk
Clinical
- Tweet this: #Korean #biopharma
Medytox expands use of @Medidata platform & adopts its
#riskbasedmonitoring #tech http://ow.ly/OEKm30bImlH
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About Medytox
Medytox, an R&D based global biopharmaceutical company,
engages in the development, manufacture, marketing and sales of
botulinum toxin and hyaluronic acid dermal filler products as its
main business. Since the successful development of the fourth
botulinum toxin type A product Neuronox in the world, Medytox has
continued moving forward by maintaining a strong position in
medical aesthetics as well as therapeutic indications which is
associated with movement disorder. Consequently, Medytox launched
HA Filler Neuramis series which may generate synergy effects along
with botulinum toxin product and launched the world’s first liquid
formulation botulinum toxin type A product INNOTOX in the Korean
and Japanese markets. And recently, it obtained an approval from
the Korean Ministry of Food and Drug Safety to sell “Coretox®,”
botulinum toxin product that is safer than its previous versions
because it excludes any animal-derived ingredients and non-toxin
proteins.
Today, Medytox is exporting its products to about 60 countries
including Japan, Thailand, Iran and Brazil. Moreover, Medytox has
been making efforts to penetrate into US and European market in the
near future. Ultimately, Medytox is going to show its presence as a
leading global biopharmaceutical company.
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 850 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 16 of the top
20 medical device developers—from study design and planning through
execution, management and reporting.
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MedidataInvestor:Medidata SolutionsAnthony
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SolutionsDa Jeong Chong, +82 2-2015-7715dchong@mdsol.com
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