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.
