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Astellas Selects Medidata Solutions as Its Standard for Electronic Clinical Trials.


One of Japan's Largest Pharmas Chooses Medidata for Expertise in Global Markets and Unique Feature Functionality, Including Paper Study and Multi-Lingual Capabilities

NEW YORK New York, state, United States
New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of
 -- Medidata Solutions, a global provider of electronic clinical data capture, management and reporting solutions, today announced Astellas Pharma Astellas Pharma Inc. (アステラス製薬株式会社   Inc. has chosen Medidata Rave 5.5 as its standard global solution for all clinical studies in Phases I-III over the next five years. Due to Medidata's global reach, comprehensive support services support services Psychology Non-health care-related ancillary services–eg, transportation, financial aid, support groups, homemaker services, respite services, and other services  and unique product scalability, Astellas plans to implement clinical trials using Medidata Rave 5.5 across North America North America, third largest continent (1990 est. pop. 365,000,000), c.9,400,000 sq mi (24,346,000 sq km), the northern of the two continents of the Western Hemisphere. , Asia, Europe and other regions.

A leader in the development of innovative pharmaceuticals, Astellas has long recognized electronic data capture and management as a mission-critical element of its clinical and business processes. Astellas selected Medidata for the company's understanding of the distinct requirements of the global clinical development process and its reliable and secure hosting and help desk services and support. Medidata Rave 5.5 is uniquely able to support Astellas' global initiatives on a single scalable platform by offering the flexibility to allow clinicians to capture, manage and report on clinical data simultaneously in the languages of their choice, including support for complete Japanese character A Japanese character may refer to:
  • Hiragana
  • Katakana
  • Kanji
See also Japanese writing system.
 sets.

"We were impressed im·press 1  
tr.v. im·pressed, im·press·ing, im·press·es
1. To affect strongly, often favorably:
 with Medidata's plan in the Japanese market and the company's unique ability to manage paper trials as well as electronic trials," said Mitsutoshi Mukai, vice president of data science at Astellas Pharma Inc. "With a reliable, scalable and user-friendly technology, Medidata is able to handle our diverse profile of global trials and allow us to focus on our core business of designing clinical programs."

Rave 5.5's Double Data Entry (DDE (Dynamic Data Exchange) A message protocol in Windows that allows application programs to request and exchange data between them automatically.

DDE - Dynamic Data Exchange
) feature will allow Astellas to collect both paper and electronic data in a single database, which provides global access for collaboration and monitoring of activities across various organizations and geographies. Rave 5.5's Local Language Translation Workbench will also eliminate costly and time-consuming translation procedures. Unlike other platforms, Rave allows users to work in their native language against a single, global, centrally-managed repository (1) A database of information about applications software that includes author, data elements, inputs, processes, outputs and interrelationships. A repository is used in a CASE or application development system in order to identify objects and business rules for reuse.  of clinical data without requiring the installation of unique language software versions.

"We are deeply honored for Medidata Rave to have been chosen as Astellas' electronic clinical data management solution, and share in their vision for streamlining a wide range of clinical trials. This relationship further highlights our success and commitment to delivering outstanding levels of service, quality and reliability," said Tarek Sherif she·rif also sha·rif  
n.
1. A descendant of the prophet Muhammad through his daughter Fatima.

2. The chief magistrate of Mecca in Ottoman times.

3. A Moroccan prince or ruler.
, CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board.  of Medidata Solutions. "Medidata's infrastructure was built to flexibly and cost-effectively scale up or down to manage trials of any size within a company's portfolio, and we look forward to collaborating with the Astellas team as they standardize stan·dard·ize
v.
1. To cause to conform to a standard.

2. To evaluate by comparing with a standard.
 their global clinical trial procedures using Rave."

About Astellas Pharma Inc.

Astellas Pharma Inc., located in Tokyo, Japan, is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. The organization is committed to becoming a global mega pharmaceutical company by combining outstanding R&D and marketing capabilities and continuing to grow in the world pharmaceutical market. For more information on Astellas Pharma Inc., please visit the company's web site at www.astellas.com.

About Medidata Solutions Worldwide

Medidata Solutions helps the world's leading pharmaceutical, biotechnology, medical device and research organizations maximize the value of their clinical research investments. Innovative process design, technology and services streamline clinical trials by providing early visibility to reliable clinical data - the lifeblood life·blood  
n.
1. Blood regarded as essential for life.

2. An indispensable or vital part: Capable workers are the lifeblood of the business.
 of every research organization. Working with companies and institutions both large and small, Medidata Solutions helps clinical researchers safely accelerate the process of bringing life-enhancing treatments to market - on five continents and in more than 70 countries. Medidata Solutions brings significant value to its broad client base with deep clinical experience and expertise in more than 20 therapeutic areas, projects in Phase I, II, III, IV, registries and surveillance, and studies with thousands of investigators and tens-of-thousands of subjects. For more information, please visit www.mdsol.com.
COPYRIGHT 2006 Business Wire
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Copyright 2006, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:Oct 23, 2006
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