CDISC CONNECTATHON SUCCESSFULLY DEMONSTRATES PROOF OF CONCEPT

Austin, TX - 5 September 2001 - The Clinical Data Interchange Standards Consortium (CDISC) presented a successful "proof of concept" demonstration at the Clinical Data Connectathon, a singular event held at this year's DIA Annual Conference in Denver. The purpose of the Connectathon was to demonstrate the utility of the CDISC operational data model (ODM), which is key to standardizing and supporting the exchange of data between various acquisition sources and operational clinical research databases. Its success marks a major milestone in the development of worldwide data interchange standards for the biopharmaceutical industry.

CDISC, including over 20 of its Corporate Sponsors, created the Denver "Connectathon," a term first coined by Jim Becker, President PHT Corporation. At this event, which drew an estimated 1,000 attendees to a hotel near the DIA Conference, the CDISC participants demonstrated the ability to work with a common ODM XML dataset among a variety of systems and applications.

"The Connectathon was the highlight of the conference. It was awesome to see the CDISC efforts making trial data and trial management information more portable and accessible. The data model and use of XML standards really lessens the number of hours required for mapping data, writing control files and developing API's," said Meredith Nahm, who currently serves as Director, Clinical Data Integration, Duke Clinical Research Institute.

CDISC sponsors, many of whom are rivals in this highly competitive industry, are united by the prospect of saving millions of dollars annually in time and money spent on activities directly related to industry data exchange. It is estimated that the industry spends well over $150 million annually on data exchange between biopharmaceutical companies and CROs, technology providers, or clinical laboratories.

"The participants were wonderful in rising to this CDISC Clinical Data Connectathon challenge. Many of them went over and above the test plan and actually connected with each other, which is what we had hoped for but did not expect to occur in this first proof of concept," said Rebecca Kush, President and Founder of CDISC. "There were even interstate and global connections among pharmaceutical companies, CROs, and technology providers."

"The Connectathon was a terrific success. Many pharmaceutical sponsors were very interested in our demonstration of the ODM," said Paul Bleicher, Chairman, Phase Forward. "We look forward to establishing working data exchange with our business partners based on the CDISC ODM." Although the Connectathon testing was based upon Version 1.0 of the ODM model, the CDISC ODM team was already working on their new and improved Verion 1.1 model, which should be released early this fall.

"The Connectathon was successful beyond our wildest imaginations," said Steve Ruberg, Clinical Data Technology and Services Director for Eli Lilly and Chairman, CDISC Board of Directors. "There is a real hunger for industry standards and there is a gathering momentum for supporting CDISC's data models." CDISC Sponsors, a multidisciplinary group that include biopharmaceutical companies, technology providers, contract research organizations, clinical laboratories, and others in the biopharmaceutical industry, have grown from 19 charter sponsors to well over 50 in the past year.

CDISC is an open, multidisciplinary, non-profit organization committed to the development of worldwide standards to support the electronic acquisition, exchange, submission and archiving of clinical trials data and metadata for medical and biopharmaceutical product development. The CDISC mission is to lead the development of global, vendor neutral, platform-independent standards to improve data quality and accelerate product development in the pharmaceutical industry.

For more detailed information about the Clinical Data Connectaton or CDISC in general, please visit the CDISC website at http://www.cdisc.org/.

-#-