Elan Selects Medidata Rave to Support Clinical Development Activities

FOR IMMEDIATE RELEASE

Elan Selects Medidata Rave to Support Clinical
Development Activities
Neuroscience-Based Biotechnology Company Implements Industry’s Leading EDC
Solution to Improve Study Efficiency and Gain Instant Access to Study Data
 
NEW YORK, NY – December 17, 2007 – Medidata Solutions today announced that Elan Pharmaceuticals, Inc. has selected Medidata Rave® as its electronic data capture (EDC), management and reporting solution. Elan plans to begin using Rave in mid- and latestage clinical studies in North America.

Elan had limited previous experience using EDC and conducted mainly paper-based trials. After a careful evaluation of the market landscape, Elan’s management team identified EDC as a critical component in clinical research and began looking for an EDC solution that could address two major concerns. First, the product had to easily integrate the data collected in an EDC system with other systems across the company, as well as systems used by external vendors and partners. Second, because much of Elan’s data management is outsourced, the company needed a solution that could be readily adopted by a contract research organization (CRO) without prior experience with the technology.

Elan ultimately selected Medidata as its EDC provider from a field of competitors, and by fully integrating Medidata Rave across Elan’s systems and clinical processes, the company expects to achieve greater access to clinical and operational data that will enable earlier decision-making throughout each trial.

Medidata Rave offers several key benefits:

A robust architecture that would easily integrate with their existing systems in order to securely and efficiently share data;
High acceptance by investigators;
An easy learning curve, making the implementation of an additional data system non-disruptive to researchers;
Instant access to clinical data, making it easier to predict and prioritize monitoring efforts to make site visits more effective;
Intuitive case report forms (CRFs) that may help Elan data managers to reduce “petty queries,” keeping studies on time more often;
The ability to access data in real time, allowing monitors to catch and respond to problems as early as possible.
 

“Each customer’s clinical requirements differ, and Medidata is unique in our ability to critically evaluate the technical and clinical needs of researchers to understand how Rave can properly complement existing systems and enhance the experience of each individual customer,” said Tarek Sherif, CEO of Medidata Solutions. “Medidata is proud to work with Elan as it moves toward its goal of delivering promising therapeutics as safely and effectively as possible to serve patients and the health care providers caring for them.”

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 life-enhancing treatments to market – on six continents and in more than 80 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-ofthousands of subjects. For more information, please visit www.mdsol.com.

Contact:
Susan Lombardo
Lois Paul & Partners
781.782.5767
susan_lombardo@lpp.com