Medytox to Further Expand Global Presence by Increasing Its Adoption of the Medidata Clinical Cloud®

NEW YORK–(BUSINESS WIRE)– 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.”

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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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