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Daiichi Pharmaceutical Selects Medidata Solutions for Cost-Effective, Multilingual Clinical Trials.


Leading Japanese Sponsor Achieves Cost Savings and Faster Time to Database Lock; Medidata Rave Leveraged in Company's Critical Cardiovascular Study

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 that Daiichi Pharmaceutical Co., Ltd. has chosen Medidata Rave for its ability to efficiently and cost-effectively manage multilingual clinical trials, and ultimately bring life-enhancing treatments to market faster. As Medidata Solutions' first customer in the Japan market, Daiichi has successfully implemented six clinical trials, including a Phase II, 500-patient, 60-site study for a cardiovascular drug. Daiichi plans to continue to use Medidata Rave for additional Phase I, Phase II and Phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA  studies in other therapeutic areas.

Daiichi previously tried two different electronic data capture (EDC EDC

See: Export Development Corp.
) solutions before selecting Medidata Rave. The company was impressed with Rave's ability to shorten time to database lock, manage data in multiple locations worldwide and help comply with global regulatory requirements. These benefits, combined with Rave's ability to consolidate several IT functions by providing EDC and clinical data management (CDM 1. CDM - Content Data Model
2. CDM - Code Division Multiplexing
) in one system, will ultimately help Daiichi streamline clinical trials and increase ROI (Return On Investment) The monetary benefits derived from having spent money on developing or revising a system. In the IT world, there are more ways to compute ROI than Carter has liver pills (and for those of you who never heard of that expression, it means a lot). .

"Medidata Solutions brings a combination of both IT and clinical expertise, which has enabled us to accelerate our clinical trials process, while also ensuring data quality," said Mikio Mori, manager, GCP GCP Good Clinical Practice
GCP Ground Control Point
GCP Global Carbon Project
GCP Gateway Control Protocol
GCP Global Consciousness Project
GCP Granulocyte Chemotactic Protein
GCP Grand Central Parkway (New York) 
 & Data Management Group, Data & Biostatistics biostatistics /bio·sta·tis·tics/ (-stah-tis´tiks) biometry.

bi·o·sta·tis·tics
n.
The science of statistics applied to the analysis of biological or medical data.
 Center, R&D Division, Daiichi Pharmaceutical Co., Ltd. "We've seen EDC deployment in Japan growing in recent months, and with Medidata Solutions' increasing presence and support services support services Psychology Non-health care-related ancillary services–eg, transportation, financial aid, support groups, homemaker services, respite services, and other services  within our region, combined with their ability to effectively communicate with clients around the globe, we expect continued success from our partnership with Medidata Solutions."

Mori anticipates that Daiichi will continue to see significant clinical development cost reductions through the use of Medidata Rave for data entry, data management and programming.

"Japan is a strategic growth area for Medidata Solutions, and we're proud to add such a prominent company like Daiichi to our client roster," said Medidata Solutions 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.  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.
. "We designed Rave to meet the requirements for global trials, and look forward to continuing to work with Daiichi on successful, cost-saving and life-enhancing clinical studies."

In selecting Medidata Solutions, Daiichi also considered the benefits Rave brings to the user and site level. Investigators and clinical research coordinators are able to find data entry errors and protocol deviations much faster, leading to better study protocol compliance, and also benefit from clearer role definitions with Rave's Task Summaries. Data monitors have real-time access to patient data and recruitment status, which is useful for efficient planning of daily activities, and are also better alerted to serious adverse events via Rave's e-mail functionality, ultimately improving patient safety. Additionally, data managers receive cleaner data and reduce queries, paperwork and time to database lock.

About Daiichi Pharmaceutical Co., Ltd.

Daiichi Pharmaceutical Co., Ltd., headquartered in Tokyo, was established in 1915 and employs over 3,400 people. The Company achieved sales of JPY JPY

In currencies, this is the abbreviation for the Japanese Yen.

Notes:
The currency market, also known as the Foreign Exchange market, is the largest financial market in the world, with a daily average volume of over US $1 trillion.
 278 billion and pre-tax profit of JPY57 billion in the last financial year. Daiichi is in the process of business integration with another pharmaceutical company, Sankyo Co., Ltd., and will become Japanese second largest pharmaceutical company as Daiichi Sankyo Co., Ltd. For more information on Daiichi Pharmaceutical, visit www.Daiichipharm.co.jp.

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
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2006, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:Oct 24, 2006
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