Chugai Deploys RaveX to Modernize Post-Marketing Surveillance

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Tokyo-based Pharmaceutical Company Expands Use of Medidata's Unified Technology Platform to Simplify Study Navigation, Improve Data Quality and Speed Data Entry Times

NEW YORK--( )-- Medidata (NASDAQ:MDSO), the leading global provider of cloud-based solutions and data analytics for clinical research, today announced that Chugai Pharmaceutical Co., Ltd. (TOKYO:4519) has expanded its use of the Medidata Clinical Cloud®, becoming the first global pharmaceutical company to adopt RaveX—the latest version of Medidata Rave®—for its post-marketing surveillance (PMS).

The industry's leading cloud-based technology for electronic data capture (EDC), management and reporting, RaveX provides an intuitive and efficient user interface for improved navigation, faster data entry and cross-subject overview visualizations. Chugai will use the platform to seamlessly navigate between its Phase I-III clinical trial data and PMS data in a single, unified system.

Yoshiaki Ohashi, vice president, head of quality & regulatory compliance unit and general manager of drug division from Chugai commented, "Once new drugs launch, it is necessary to quickly initiate post-marketing surveillance in order to assure safety profiles, practice risk management properly, and inform patients and health practitioners of any new indications or side effects. However, it has been a challenge to launch EDC systems for PMS in a short period of time. RaveX enables Chugai to shorten our lead times by about 50% and scale to any surveillance size, which is why we selected the globally-validated Medidata platform for our programs. In combining Medidata's enhanced technology and vast experience in clinical research optimization, we expect to overcome many common challenges associated with conducting PMS."

A long-time Medidata customer, Chugai has been using Medidata Rave, as well as integrated capabilities that plug into the EDC system—including medical coding and adverse event reporting—to advance its R&D pipeline. Now, Chugai will deploy RaveX as a major part of its PMS, improving data quality and accessibility around key safety issues.

"We're pleased to further our relationship with Chugai, a strong player in the global pharmaceuticals market that is pursuing innovative drug candidates to benefit the medical community worldwide," said Takeru Yamamoto, managing director of APAC. "Post-market surveillance is an incredibly important aspect of drug development, providing real-world data to further inform the safety of therapies after the clinical trial process. As the cornerstone of the Medidata Clinical Cloud, RaveX is helping Chugai get the real-world data and actionable insights they need, accurately and quickly—optimizing their overall research investments and delivering more value to patients. We're proud to provide the industry with best-in-class technology to work more efficiently and lead to innovative new discoveries in medicine."

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About Chugai

Chugai Pharmaceutical is one of Japan's leading research-based pharmaceutical companies with strengths in biotechnology products. Chugai, based in Tokyo, specializes in prescription pharmaceuticals and is listed on the 1st section of the Tokyo Stock Exchange. As an important member of the Roche Group, Chugai is actively involved in R&D activities in Japan and abroad. Specifically, Chugai is working to develop innovative products which may satisfy the unmet medical needs, mainly focusing on the oncology area.

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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 18 of the top 25 medical device developers—from study design and planning through execution, management and reporting.

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