Daiichi Pharmaceutical Selects Medidata Solutions for Cost-Effective, Multilingual Clinical Trials
FOR IMMEDIATE RELEASE
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, NY – October 24, 2006 – 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 studies in other therapeutic areas.
Daiichi previously tried two different electronic data capture (EDC) 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) in one system, will ultimately help Daiichi streamline clinical trials and increase ROI.
“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 & Data Management Group, Data & Biostatistics 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 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 Tarek Sherif. “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 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 of every research organization. Working with companies and institutions both large and small, Medidata Solutions helps clinical researchers safely accelerate the process of bringing lifeenhancing 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.
Contact:
Susan Lombardo
Lois Paul & Partners
781.782.5767
Susan_Lombardo@lpp.com