FOR IMMEDIATE RELEASE
Industry’s First Local Language Translation Workbench Allows for Truly Global, Enterprise-
Wide EDC Deployments; Double Data Entry Feature Merges Paper and Electronic Trials
Rave 5.5 Unveiled at Bio-IT World, Partnerships for CROs and
Annual DIA Clinical Data Management Symposium
NEW YORK, NY – March 27, 2006 – Medidata Solutions, a global provider of electronic clinical data capture, management and reporting solutions, today announced the introduction of Rave 5.5, the first EDC product to allow sponsors to run all of their clinical trial operations, regardless of the study phase, geography or language requirements, on one global platform. Unlike other products that require the installation of different versions of software for each language, Rave 5.5 offers one unified solution that can be viewed in any language—creating a fluid platform and central repository for all data managers and clinicians working in worldwide locations.
A complete clinical data management solution designed for biopharmaceutical companies, medical device and research organizations, Rave 5.5 eliminates the costly and timeconsuming procedures traditionally faced by sponsors when deploying global trials. With Rave 5.5’s Local Language Translation Workbench, application screens and study definitions, such as form names, can be presented in any language, including Asian languages. Users can work in their language of choice against a single, global, centrally-managed repository of clinical data. Web-based tools allow for the translation of data entry screens into multiple languages, and pick-list data can be presented to users in their local language and automatically translated for reporting and analysis. As a result, sponsors avoid the burden of recreating separate clinical research forms (CRFs) in multiple languages.
“With an increasing number of sponsors looking to implement global, enterprise-wide trials, Rave 5.5 saves time and alleviates costs associated with translations of clinical data,” said Tarek Sherif, CEO, president and co-founder of Medidata Solutions. “Sponsors are now able to capture, manage and report on clinical data in the language of their choice and gain earliest visibility into critical data to drive better decision-making, increased ROI and lower overall risk.”
In addition to the Local Language Translation Workbench, Rave 5.5’s Double Data Entry (DDE) features allow for paper and paper/EDC hybrid studies to be run on a common platform. Using DDE, both heads-up and heads-down double data entry processes can be run within the same enterprise-level installation that sites use to directly enter data over the web. Using an innovative Web development technique called Ajax (Asynchronous JavaScript And XML), Rave 5.5’s DDE provides users with a client-server application experience, but with truly thin-client deployment efficiency. The thin-client nature of DDE also allows sponsors and CROs to collaborate in new ways, given the ability to provide seamless access to EDC, double data entry, data management and monitoring across organizations and geographies.
Rave 5.5 also introduces a new Central Lab Data feature, which supplements the Local Lab Data capture functionality introduced in Rave 5.4 and provides industry-leading capabilities for managing lab data and ranges. Rave 5.5 allows for the definition of central labs and their corresponding ranges and can automatically vary them according to any user-defined criteria, such as age, sex and fasting status. When lab data is entered or loaded, the values are automatically compared against the appropriate lab range and out-of-range values are flagged, providing earlier insight into clinical errors and anomalies. Users can also be automatically prompted to identify which of these out-of-range values are clinically significant.
“In addition to Rave’s new multi-lingual capabilities, the DDE and Central Lab Data features were created to provide a truly robust clinical data management platform along with Rave’s existing ease of use for sites and monitors,” said Glen de Vries, chief technology officer of Medidata Solutions. “The comprehensive multi-trial data management and EDC platform will drive user adoption and satisfaction at the site level by streamlining communications between the sponsor and the medical community and will ultimately increase efficiencies throughout the clinical process.”
Medidata Solutions will be showcasing Rave 5.5 at the following industry events:
21st Annual DIA Clinical Data Management Symposium & Exhibition, March 26–29, Philadelphia, booth #313
Bio-IT World Life Sciences Conference & Expo, April 3–5, Boston, booth #147
IIR’s Partnerships with CROs, April 4–5, Las Vegas, booth #325.
About Medidata Solutions Worldwide
Medidata Solutions helps the world’s leading pharmaceutical, biotechnology and medical device companies realize the maximum potential value from their clinical research investments. Working with companies large and small, Medidata Solutions helps accelerate the process of bringing life-enhancing treatments to market—on five continents and in more than 70 countries. Innovative process design, technology and services can streamline clinical trials by providing early visibility to clinical data for faster decision-making, optimized resources and lower execution risk. Medidata Solutions’ broad client base and deep clinical experience provide value for the world’s leading pharmaceutical, biotechnology and medical device companies, 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. To learn more about Medidata Solutions, please visit www.mdsol.com.
Contact:
Susan Lombardo
Lois Paul & Partners
781.782.5767
Susan_Lombardo@lpp.com