Chugai Deploys RaveX to Modernize Post-Marketing Surveillance

NEW YORK–(BUSINESS WIRE)– 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.

Additional information is available on our website at https://www.chugai-pharm.co.jp/english/.

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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