Medidata Solutions, Inc.
05/15/17

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

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

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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Source: Medidata

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