Medidata Solutions Introduces Latest Enhancement to Medidata Rave

Company News Release

Latest enhancement to its leading electronic data capture (EDC), management and reporting system, Medidata Rave the Dynamic Tabulation Engine.

FOR IMMEDIATE RELEASE



MEDIDATA SOLUTIONS INTRODUCES FURTHER DEPTH AND FLEXIBILITY IN REPORTING TRIAL DATA WITH LATEST ENHANCEMENT TO MEDIDATA RAVE

New Data Management Tool in Leading EDC/CDMS Solution Speeds Access to Clinical Data, Boosts Flexibility in Preparing Data for Analysis and Submission, Supports SDTM To be Demonstrated at DIA


NEW YORK, N.Y. – June 24, 2008 – Medidata Solutions, a global provider of clinical trial solutions, today introduced the latest enhancement to its leading electronic data capture (EDC), management and reporting system, Medidata Rave® – the Dynamic Tabulation Engine™. This new feature expands Rave’s data-reporting capabilities and further increases the ease and speed at which clinical data can be made available for analysis, reporting and regulatory submissions in sponsor-specific or standards-based formats as they evolve, such as Study Data Tabulation Model (SDTM).

Research sponsors today spend significant time and effort in converting clinical data captured in EDC and clinical data management systems to a format that is usable by statistics and regulatory teams. To do so, sponsors must employ a complex process of custom-built transformations that require significant programmer input and third-party tools. Rave’s new Dynamic Tabulation Engine empowers clinical researchers and data managers with a user-friendly interface that allows them to flexibly define how real-time clinical data sets and tables are collated, formatted and extracted. Clinical data can then be immediately viewed within Rave, extracted to an external data-warehouse or processed by powerful third-party reporting and analysis tools such as Business Objects®, J-Review®, and SAS®. This significantly reduces the complexity and time involved in creating such tabulations, and can remove the need for custom software development or additional data-transformation tools, such as Extract-Transform-Load (ETL) applications. Once defined, tabulation formats can be reused across studies in Rave, streamlining data extraction and ensuring consistency across studies and throughout the clinical research process.
 
“Since its inception, Medidata Rave was designed to provide sponsors and CROs with fast and flexible access to quality clinical data,” said Glen de Vries, President of Medidata Solutions. “By augmenting Rave’s existing powerful reporting tools with built-in data extraction capabilities that are unparalleled in the industry, Medidata saves sponsors and CROs time and effort in readying clinical data for analysis and submission, which could potentially reduce time to market of new drugs and therapeutics.”

Rave’s Dynamic Tabulation Engine is being demonstrated at the 2008 DIA Annual Meeting (Medidata booth #1220) and will show how easily SDTM domains can be created and reported from data entered in Medidata Rave. SDTM is a widely-adopted standard for the electronic submission of tabulated data to the FDA in support of marketing applications at the completion of a trial. SDTM was developed by the Clinical Data Interchange Standards Consortium (CDISC), a global, industry-supported non-profit organization that establishes standards to support the acquisition, exchange, submission and archive of clinical research data and metadata.
 
The Dynamic Tabulation Engine will be generally available in the third quarter of this year as an add-on module capable of supporting Rave customers with versions 5.6.2 and above who are interested in leveraging the powerful tool at no additional cost.
 
 
About Medidata Solutions Worldwide
Medidata Solutions (www.mdsol.com <http://www.mdsol.com/> ) is a leading provider of clinical trial solutions that enable the world’s most advanced life science organizations to maximize the value of their clinical research investments by putting powerful tools into researchers’ hands. A pioneer since 1999 in innovative technologies for planning and managing clinical studies – including protocol design; clinical data capture, management and reporting; and trial contracting and negotiation – Medidata Solutions and its global network of business partners address the unique needs of sponsors and sites of all sizes. With deep expertise in conducting studies across all phases and therapeutic areas, on six continents and in more than 80 countries, Medidata Solutions helps clinical researchers reduce trial cycle times, achieve early visibility to reliable clinical data, and maintain strict fiscal responsibility, while safely accelerating the process of bringing life-enhancing treatments to market.


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