Medidata Rave Receives Complete CDISC ODM Certification


Medidata Rave becomes the first and only clinical trial solution certified on all eight uses of the Operational Data Model.

New York, NY-April 21, 2008-Medidata Solutions, a leading provider of clinical trial solutions, today announced that its electronic data capture (EDC), reporting and management solution Medidata Rave has been certified by the Clinical Data Interchange Standard Consortium (CDISC) as complying with the Operational Data Model (ODM) standard. The first and only clinical trial technology company to be certified on all eight available CDISC ODM uses for importing and exporting clinical study data, Medidata further demonstrates its commitment to providing sponsors and partners with interoperable products that promote efficiencies and ensure effective data exchange throughout the clinical development process.

CDISC is 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 organization introduced the ODM certification program in 2007 to ensure consistency across toolsets and interoperability between ODM implementations. The ODM Standard is currently recognized as the ideal transport method for data across the entire clinical trial enterprise.

“Our mission at CDISC is to develop and support global, platform-independent data standards that enable information system interoperability-across sponsors, partners and vendors-to improve the process of medical research,” said Dave Iberson-Hurst, vice president of technical strategy at CDISC. “We appreciate the diligence and commitment to standards that Medidata has demonstrated in choosing to be the first vendor certified on all the use cases within the current certification program and share in their excitement to promote wider adoption of clinical standards.”

The certification for CDISC ODM involves a rigorous process that only a handful of products in the industry have obtained, including Medidata Designer, the only ODM-certified application capable of generating structured protocol information. Medidata Rave’s rich suite of data import and export capabilities is now fully certified on all eight use-cases, which include:

•ODM Metadata Snapshot-Import and Export

•ODM Data Snapshot-Import and Export

•ODM Metadata Transactional-Import and Export

•ODM Data Transactional-Import and Export.

The certification of Medidata Rave on all eight ODM use-cases ensures end-to-end system compatibility and effective data exchange in full compliance with the industry’s leading standards.

“Medidata’s decision to support across-the-board ODM certification was a direct response to our customers’ needs and is consistent with our belief that coupling innovation with adherence to industry standards is key to providing sponsors and partners with efficient, interoperable solutions that increasingly streamline the process of clinical development,” said Andrew Newbigging, senior director of research and development at Medidata. “An ever-growing number of companies are relying on CDISC for industry standards, and we look forward to partnering with the organization on future initiatives.”

Several Medidata executives are currently active in the CDISC community. Andrew Newbigging, David Gemzik, vice president of implementation services and trial planning solutions, and Ed Seguine, general manager of trial planning solutions, will each deliver presentations at the CDISC European Interchange 2008 in Copenhagen this week. Ed Seguine was also recently appointed to chair elect of the CDISC Industry Advisory Board, while Peter Abramowitsch, vice president of development and trial planning, is a recipient of a 2007 CDISC Team Award and participates in the Protocol Representation Group. Lily Wong, project analyst team lead, represents Medidata in the CDASH group.

About Medidata Solutions Worldwide

Medidata Solutions (

) 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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