Medidata Rave Receives Complete CDISC ODM Certification



    Medidata Solutions, Inc., a leading provider of clinical trial
    solutions, today announced that its electronic data capture (EDC)

    reporting and management solution Medidata Rave(R) 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(TM), 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 (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.