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CDISC Interchange Promises New Views into Healthcare's Interoperability with Medical Research

AUSTIN, Texas-(Business Wire)-October 2, 2008 - The Clinical Data Interchange Standards Consortium (CDISC) announced today an authoritative line up of keynote speakers and the promise of a robust information exchange forum at this year’s CDISC International Interchange (26-31 October 2008). The Interchange will focus on two major themes: implementation experiences with CDISC standards and creating the interoperable pathway between medical research and healthcare.

“This year’s program is one of the most exciting and thought-provoking that CDISC has developed yet” says CDISC President and CEO, Rebecca Kush. “We are very pleased to have a number of outstanding keynote speakers, including Dr. John Halamka, Chair of the HITSP Board and Panel, who will present his experiences and observations on ‘Connecting Clinical Research, Patients, Providers and Payers’.”

Additional keynote presentations will include:

The FDA’s Dr. Rachel Behrman who will present an up-to-date report on the progress and lessons learn along the FDA’s Critical Path Initiative
Invited Keynote: “China's Clinical Trial Development: History, Current Status, and Future", CDISC has invited the New Drug Evaluation team from China’s State Food and Drug Administration (SFDA) to join the CDISC 2008 International Interchange Conference. The visiting SFDA team plans to present this timely glimpse into the role of SFDA in clinical research in China.

CDISC will also feature an FDA Session with presentations by Patricia Garvey (Office of Critical Path Programs), Gary Gensinger and Steve Wilson (CDER) and Amy Malla (CBER). This session will be followed by the very popular open Q & A session with a panel of FDA and CDISC experts.

As a new feature for the Interchange, CDISC will also host a live demonstration of a CDISC Healthcare Link initiative – EHRs in Clinical Research. In collaboration with research sponsor organizations and EHR vendors, the demonstration will showcase how CDISC standards can facilitate data capture from the electronic health record for various clinical research purposes with the use of an IHE integration technology know as RFD (Retrieve Form for Data Capture).

Finally, there will be a full two tracks of talks, selected from a field of abstracts and presented by industry speakers, covering topics on CDISC standards progress and implementation. And in the days preceding and following the conference, CDISC will be offering a full complement of instructor-led training courses on the CDISC standards.

“Given the state of the global economy our goal was to put together a program that would provide attendees with modestly-priced quality information exchange and networking opportunities - an event that would contain all the latest information, emerging ideas in the area of standards implementation and interoperability between biomedical research and healthcare. From regulatory updates to implementation issues, key global trends and CDISC training, we have created an information-rich forum that is accessible, interactive and educational,” stated Frank Newby, CDISC Chief Operating Officer.

Further information about the CDISC 2008 International Interchange, including the full program, registration and hotel information is available on the CDISC website at www.cdisc.org/events.

ABOUT CDISC

CDISC is a global, multidisciplinary, non-profit organization that has established open global standards to support the acquisition, exchange, submission and archive of medical research data. The CDISC mission is to develop and support platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare. CDISC has a Charter Agreement with HL7, in place since 2001, with a commitment to harmonize clinical research and healthcare standards. CDISC has Liaison A status with ISO TC 215 for Healthcare Standards and has been accepted as a member of the Joint Initiative Council (JIC) along with HL7, ISO, and CEN. The CDISC standards are freely available via the CDISC website at www.cdisc.org.

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