Medidata Solutions Unveils Rave 5.4 At DIA Annual Meeting.

NEW YORK -- Industry's First Unified Platform for Clinical Data Management Further Increases User Adoption Rates and Streamlines Clinical Development for Higher ROI 

Rave 5.4 Demoed at Medidata Booth #719 and Microsoft Digital Pharma Booth #1343

Medidata Solutions, a global provider of electronic clinical data capture and clinical data management solutions, today announced the introduction of Medidata Rave 5.4 at the Drug Information Association (DIA) Annual Meeting in Washington, DC. Through user-friendly tools for the capture, management and reporting of clinical trial data, Medidata Rave 5.4 helps pharmaceutical, biotechnology and medical device companies streamline clinical trial processes, have early insight into study bottlenecks and leverage an intuitive interface for widespread site adoption with both thin client and offline synchronized data capture tools.

One of the major obstacles in conducting efficient e-clinical trials is ensuring that users adopt new technologies. For all participants in the clinical process - from investigators and nurses to monitors and data managers - new applications need to be easy to use and deploy, as well as provide both short and long-term value. Medidata Rave 5.4 was designed with all study constituents in mind, making tasks such as site data entry, surveillance data capture, local lab data integration, study configuration and system administration faster and more efficient, ultimately increasing user acceptance. Medidata Rave 5.4 also provides a highly-scalable platform for global trials and offers integrated dictionary coding functionality and automated data migration for CRF revisions. For the sponsor, Medidata Rave 5.4 provides the earliest visibility into critical data to drive better decision-making, increase ROI and lower overall risk.

"Medidata Rave enabled us to implement a user-friendly solution for clinical data collection and cleaning on PCs and laptops across more than 230 sites," said Louis Pozzo, manager of clinical trials and relationship management at Janssen Pharmaceutica. "The new features in Rave 5.4 will allow our clinical sites to easily and effectively work off-line for higher site adoption and increased efficiencies across trials."

"As the industry continues to evolve, our biopharmaceutical and medical device customers rely on technology not just to capture and manage clinical data, but to derive measurable value from early access to that data," said Tarek Sherif, CEO, president and co-founder of Medidata Solutions. "The Rave 5.4 platform was specifically designed to appeal to the sponsor looking to increase ROI and for the end-user, with a focus on intuitive improvements in flexibility, functionality and overall ease-of-use."

Rave 5.4 Adds Value Across All levels of the Clinical Development Process

New enhancements include:

--Easy to Use Local Lab Data Capture and Management - Because a significant portion of clinical studies involve local lab data, Medidata Rave 5.4 allows monitors to catch discrepancies earlier by automatically performing unit conversions, comparing data to lab and reference ranges and providing central and site-based tools for analyte and range management. All local lab data is automatically processed and made available for review and analysis in real-time, and the system can handle conversions of fractional to absolute values that traditionally require batch or delayed processing.

--Automated CRF Version Management and Migration - Medidata Rave 5.4's CRF Migrator provides a web-based system for managing the migration of existing subject data from one CRF version to another. The Migrator Wizard also provides the ability to upgrade CRF forms, backend data structures and edit checking rules without the need to take down a system, enabling customers to run concurrent studies across multiple time zones without interruption.

--Integrated Dictionary Coding - Medidata Rave 5.4's CRF Dictionary Coding streamlines the coding process, saving time by automating coding tasks that traditionally required manual intervention or the use of additional systems. Dictionary coding and browsing is integrated directly within the data capture application and workflow, allowing coders to work within the context of the CRF and enabling data managers to review coding within a single data management tool.

--User-Friendly Remote Data Cleaning and Collection - Medidata Rave Remote allows e-clinical research data to be collected and cleaned on PCs that are not permanently connected to the Internet. Sites and monitors can enter and verify data from virtually any PC while offline using the identical easy-to-use interface as Medidata Rave's thin client web-based tools. In addition, sites can intelligently synchronize with a central server and resolve data conflicts using a modem or other Internet connection. No special firewall rules are required, minimizing the complexity and cost of deploying Medidata Rave Remote.

--Rapid Report Generation and Multiple Subject Views - Through Medidata Rave 5.4's Clinical Views feature, study team can browse up-to-date, real-time data. Medidata Rave's workflow and security models are fully integrated into reporting and data browsing tools, so blinding, privacy and regulatory procedures that are created for use the Medidata Rave Capture are automatically extended in data reporting. Data entry tools have also been enhanced with both task, calendar and subject overview views, allowing users to quickly and easily navigate through CRFs online.

--Enhanced Report Administration - Additional reporting tools in Rave 5.4 bring more options for views into data and better decision-making at every level. Users can now add custom reports and define parameters for custom reports, such as activating, deactivating, deleting, renaming or changing a report's description through online administration tools.

--Improved Security and Privacy Compliance Through Subject Status Workflow Restrictions - Rave 5.4 introduces the ability to restrict access to subjects based on each subject's status. Specifications of which subject statuses are visible are done by a user's role permissions and status can be changed in real-time based on data workflow. This allows sponsors to easily accommodate the legislative privacy requirements when working in multiple countries with different regulatory requirements.

--Multi-byte language support and Integrated Translation Tools - Medidata Rave 5.4 includes support for Unicode characters in the user interface, data entry screens and clinical data itself. Web-based tools allow for the translation of data entry screens into multiple languages; pick-list data can be presented to users in their local language and automatically translated for reporting and analysis; and free-text data entered in different languages, including coding data, can be queued for translators online, enabling truly global enterprise deployments.

In addition to product demonstrations at Medidata's booth #719, Rave 5.4 will be showcased in Microsoft's Life Sciences booth #1343.

"With cost and pipeline pressures on the rise, the life sciences industry needs proven technology solutions that speed the delivery of innovations to market and offer greater value for cost," said Steve Shihadeh, general manager, Microsoft Healthcare and Life Sciences. "Medidata's Rave solution, based on Microsoft's agile and intuitive technology, enables life sciences companies to reach these targets by improving business efficiencies and lowering costs associated with clinical trial development."

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.