Medidata Solutions Builds Broad CDMS Functionality into Leading EDC Platform With Rave 5.6.

New Single-Platform Clinical Data Capture, Management and Reporting Solution to be Unveiled at DIA Japan and Clinical Trials Congress

NEW YORK -- Medidata Solutions, a global provider of electronic clinical data capture, management and reporting solutions, today announced the introduction of Medidata Rave 5.6, which incorporates broad, industrial-strength data management tools into its industry-leading electronic data capture (EDC) platform. Building on Medidata Rave's multiple language capabilities, scalability and ease-of-use, Rave 5.6 offers life science research sponsors performance improvements to clinical trial processes and new tools for streamlining enterprise-wide implementations.

EDC: The New CDMS 

More and more, the need for a separate clinical data management system (CDMS) is diminishing due to sophisticated and evolving EDC technology. With Rave 5.6, Medidata has incorporated broad CDMS functionality into its widely-accepted EDC system. Medidata Rave 5.6 allows global clinical study teams to collaborate within a single system, without having to manage complex integrations and incur additional overhead for deploying and managing a separate CDMS database. As a result, sponsors are able to increase efficiency, reduce risk and scale to handle any size or phase study.

"With today's cost pressures in bringing drugs to market, sponsors want innovative solutions that allow them to begin to integrate their disparate clinical systems in order to streamline their clinical research processes and reduce total cost of bringing a drug to market," said Chris Connor, senior research analyst for clinical development at Health Industry Insights, an IDC Company. "With Rave 5.6, Medidata is taking a big step in this direction with a single instance platform for collecting and managing clinical data, enabling sponsors to reduce the resources required to implement clinical trials."

Rave 5.6: Complete Functionality, In Volume

Medidata Rave 5.6 offers an array of new features designed to help all members of the study team throughout the clinical research process. These capabilities were designed by Medidata Solutions in close collaboration with its customers and Rave users.

The following enhancements help improve efficiencies of the study build and life cycle management:

* Global Library - Speeds design of multiple studies through the reuse of previous studies or study elements, and allows for the secure and controlled establishment of standards libraries that can be leveraged across enterprise wide e-clinical deployments. Guided by a Global Library Wizard, study designers can easily select and reuse components ranging from edit checks to entire forms and visit structures.

* Architect Loader - Allows for study designs to be edited, moved and stored offline, providing a complete automatically-generated study specification and improving communication and collaboration between organizations within a sponsor, or between sponsors and outsourcing partners.

* Amendment Manager Enhancements - Extends Rave's capability to efficiently manage mid-study changes with analysis tools to determine differences between study versions, and to efficiently deploy selected changes.

Study teams also improve productivity in data capture, management and reporting with the following tools in Medidata Rave 5.6:

* CRF Attachments - Allows storage of images, documents or other digital files as part of study records with the same level of security and compliance as other clinical data.

* Local Lab Enhancements - Builds on Rave's start-of-the-art laboratory module by allowing simple referencing of sponsor-chosen ranges for local laboratory results.

* Data Clarification Forms - Generates and tracks data clarification forms (DCF) for sponsors leveraging Rave's double data entry (DDE) capabilities.

* Report Localization - Extends Rave's multilingual capabilities to reports, leveraging Rave's flexibility to present all information in the user's language of choice.

"The new features introduced in Medidata Rave 5.6 were driven by feedback from our users. As a result, we have evolved our EDC product to include deep CDMS functionality, enhancing the user experience and productivity for the entire study team," said Glen de Vries, chief technology officer of Medidata Solutions. "Customers are now looking to Rave as their new hub of clinical trial systems - not only to do it all, but do it all in volume. With multiple enhancements and strong performance improvements, Medidata Rave is becoming the transactional backbone of clinical research programs for everyone from pharmaceutical companies and biotechs to medical device and research organizations."

To hear more from de Vries on the evolution of EDC technology and the incorporation of CDMS functionality, please visit www.mdsol.com for his latest podcast, entitled "Integrated Data Management and EDC Solutions."

Medidata Solutions will also be showcasing Rave 5.6 at the following industry events:

* DIA's 10th Annual Workshop in Japan for Clinical Data Management, January 29-30, 2007, Arcadia Ichigaya

* Clinical Trials Congress, February 6-8, 2007, Las Vegas, booth #304

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 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.