Leading Japanese Pharma Chugai Standardizes on
Medidata Rave Clinical Technology

Tokyo-Based Chugai Selects Medidata Rave EDC Solution to
Drive Globalization and Increased Efficiencies in Clinical Trials

NEW YORK, N.Y. and Tokyo – January 31, 2011 – Medidata Solutions (NASDAQ: MDSO), a leading global provider of SaaS-based clinical development solutions, today announced that Chugai Pharmaceutical Co., Ltd., a member of the Roche Group and one of Japan’s leading pharmaceutical companies, has selected Medidata Rave® as the standard electronic data capture (EDC) and clinical data management (CDM) platform for its clinical trials. Chugai intends to use Medidata Rave to support all studies conducted during the multiyear contract term, from Phase I–IV.

Headquartered in Tokyo, Japan, Chugai focuses on the development of new treatments for oncology, renal and bone and joint diseases. After the company decided to streamline its clinical processes and provide better and faster access to quality data by moving away from paper-based data collection in clinical trials, it started an evaluation of several EDC systems. Based on its robust and superior range of product features, ease of use and reliability, especially for Japanese investigative sites and study teams, Chugai selected Medidata Rave.

In an effort to accelerate and enhance new drug development, Chugai has looked to Rave, a web-based system that is fast and compatible with any browser and offered the features and functions to meet Chugai’s needs. Chugai also noted that Rave’s wide use and popularity among site personnel in Japan made it a strategic choice to help drive site participation, satisfaction and retention. Additionally, Chugai is very interested in Medidata’s channel partner program, which provides a range of global Medidata-trained and accredited contract research organizations (CROs) and other outsourcing organizations to help manage aspects of sponsors’ clinical trials.

“As one of Japan’s leading pharmaceuticals, Chugai is at the forefront of developing new life-saving drugs in an increasingly global marketplace,” said Tarek Sherif, CEO, Medidata Solutions. “Medidata’s leadership in the clinical technology market in Japan, based on our strong and varied customer base and the committed partnerships we have with local, regional and global CROs, will support Chugai in leveraging the most efficient and innovative technology to support their development goals.”

As it ramps up usage of Medidata Rave for EDC studies and gains experience working with the system, Chugai also plans to implement Rave Safety Gateway to streamline adverse event reporting from sites by integrating Rave with its safety reporting systems. Chugai also is an active member of the Japan Medidata User Group (JMUG), a forum of Medidata customers that meet several times a year to share best practices.

About Medidata Solutions Worldwide
Medidata Solutions ( is a leading global provider of SaaS-based clinical development solutions that enhance the efficiency of customers’ clinical trials. For over 10 years, Medidata has consistently brought next-generation innovation to the life science industry to lower the total cost of clinical development through informed trial planning and management, optimized clinical processes and platform interoperability. Medidata’s advanced solutions address key functions throughout the clinical development process including protocol development (Medidata Designer®), trial planning and management (Medidata Grants Manager®, Medidata CRO Contractor®), user and learning management (iMedidata™), randomization and trial supply management (Medidata Balance™), monitoring (Medidata Rave Monitor, Medidata Rave Targeted SDV), Serious Adverse Events capture (Medidata Rave Safety Gateway) and clinical data capture, management and reporting (Medidata Rave®). Our diverse customer base spans biopharmaceutical companies, medical device and diagnostic companies, academic and government institutions, CROs and other research organizations, and includes more than 20 of the top 25 global pharmaceutical companies as well as organizations of all sizes developing life-enhancing medical treatments and diagnostics.

About Chugai
Chugai Pharmaceutical, specialized in prescription pharmaceuticals and based in Tokyo and listed on the 1st section of the Tokyo Stock Exchange, is one of Japan’s leading research-based pharmaceutical companies with strengths in biotechnology products. 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 with global applications, focusing on the disease areas of oncology, renal disease, and bone and joint. In Japan, Chugai’s research facilities in Gotemba and Kamakura are collaborating to develop new pharmaceuticals and Ukima is conducting research for technology development for industrial production. Overseas, Chugai Pharma USA and Chugai Pharma Europe are engaged in clinical development activities in the United States and Europe. The consolidated sales in 2009 of Chugai totaled 428.9 billion yen and the operating profit was 82.6 billion yen. We are aiming at the consolidated sales of 460 billion yen and operating profit of 80 billion yen in 2012, as stated in mid-term business plan "Sunrise 2012". Additional information is available on the Internet at

Susan McCarron
Lois Paul & Partners