Medidata Solutions Announces New Capabilities to Streamline Clinical Trial Start-Up and FDA Submissions

FOR IMMEDIATE RELEASE

Leading EDC and CDM Vendor Adds Preconfigured Forms Built on CDISC’s Industry Standard
CDASH to Increase Efficiencies and Trial Quality for Sponsors and CROs

NEW YORK, NY – October 7, 2008 – Medidata Solutions, a leading global provider of clinical trial solutions, today announced enhancements to Medidata Rave®, its unified electronic data capture (EDC) and clinical data management (CDM) platform, which will enable sponsors and CROs to quickly and efficiently build studies, streamline start-up times and submissions, and enhance trial quality.

Medidata Rave now includes preconfigured, validated, electronic case report forms (eCRFs) that comply with the CDASH Version 1.0 standard for collection of clinical safety data, published by global standards organization CDISC today. These eCRFs are mapped to SDTM-compliant reports. Used in conjunction with Rave’s newly released study design and reporting capabilities, they will enable sponsors to jumpstart EDC set-up, tailor studies to their specific needs quickly and efficiently, and reduce the risk and complexity involved in adopting a standards-based approach to study build and submissions.

The Clinical Data Interchange Standards Committee (CDISC) is an industry-supported, nonprofit
organization that establishes standards for the acquisition, exchange, submission and archive of clinical research data and metadata. In 2006, CDISC launched the Clinical Data Acquisition Standards Harmonization (CDASH) project as part of the FDA’s Critical Path initiative to standardize data collection at the investigative site level. CDASH focuses on the development of consensus-based data collection fields in CRFs across applications and sponsors. These data fields are harmonized with the Study Data Tabulation Model (SDTM), a CDISC standard referenced in FDA eSubmission Guidance on electronic submission of tabulated CRF data for drug approvals. By simplifying the compliance with these standards, Medidata Rave’s new capabilities help sponsors streamline data collection and promote improved data interoperability throughout the biomedical research and product development processes.
“The standards emerging from CDISC are key to enabling end-to-end operational excellence for sponsors and CROs and best-in-class performance of integrated eClinical solutions,” said Glen de Vries, President of Medidata Solutions. “We are removing the barriers to our customers’ adoption of these standards by providing a comprehensive array of out-of-the-box, CDISCcompliant offerings coupled with an execution framework to quickly adapt these offerings to our customers’ specific study design needs and internal standards.”

Medidata now offers all four CDASH standard packages, which include 16 standardized domains for data collection – such as adverse events, concomitant meds, vital signs, disposition, ECG and more – available as compliant eCRFs validated in Rave, including edit-checks, metadata, SDTM mappings, documentation, specifications and test-evidence. The CRFs can be reused in multiple trials through Medidata Rave’s Global Library for efficient, consistent and standardized study-build and can be loaded in their entirety or partially, as-is or as a starting point to quickly develop custom eCRFs per a sponsor’s specific research needs.

This new support for CDASH and SDTM comes on the heels of Medidata Rave’s recent certification on all eight CDISC Operational Data Model (ODM) data import and export usecases, making it the only clinical research technology solution to achieve such extensive certification. Medidata is an active member of the CDISC CDASH committee and will be providing the organization with practical feedback as a result of piloting the implementation of CDASH-compliant eCRFs with customers.

About Medidata Solutions Worldwide
Medidata Solutions (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 lifeenhancing treatments to market.

Contact:
Susan McCarron
Lois Paul & Partners
781.782.5767
Susan_McCarron@lpp.com