CCDISC Elects New Board Members and
Advances Global Clinical Data Standards

Austin, TX – 17 October 2002 – The Clinical Data Interchange Standards Consortium (CDISC) has elected three new directors for its board: Elaine Job of Aventis Pharmaceuticals, David Hardison of First Consulting Group, and Ed Helton of SAS Institute. They will each begin their three-year term on 1 January 2003.

“We are pleased to have such a balanced group of industry leaders joining the CDISC Board of Directors. Their collective experiences in the many aspects of clinical development and the perspectives they bring from their organizations will be very valuable as CDISC continues to realize its vision,” said Steve Ruberg, Chairman of the Board.

Retiring from the CDISC Board are three members of the original CDISC Steering Committee, which was responsible for transitioning CDISC from a volunteer group to its current status as a non-profit organization. These three retiring directors, whose terms expire at the end of 2002, are David Christiansen, Kaye Fendt and Wayne Kubick.

“The board is very thankful for the dedication and commitment shown by our retiring board members. Their perseverance has been a major factor in the success of CDISC to date,” said Scott Neuville, a current board member. This begins a new phase of executive governance for CDISC, which has implemented a transition process that allows three new board members to be elected each year as three members rotate off the board.

In a related announcement, CDISC announced its plans for transitioning the leadership for its Industry Advisory Board. For the past two years, Elaine Job has served as the chair of the CDISC Industry Advisory Board (IAB), which is composed of one representative from each of the CDISC corporate sponsors. Replacing Job in this IAB leadership position are co-chairs, Michele Thomas of GlaxoSmithKline and Don Rosen of Lincoln Technologies.

In addition to these changes in board leadership, CDISC has added to its operational staff by hiring a leader of education and member relations---Frank Newby, who holds a degree in biology and education and has 22 years of experience in information technology and data management within the

pharmaceutical industry. Newby will focus on expanding CDISC sponsorship/ membership and the implementation of a broad curriculum of CDISC courses to be offered frequently throughout 2003. He will report directly to Rebecca Kush, President of CDISC.

In an effort to formalize global CDISC representation and organization, while facilitating local activities in Europe, Udo Siegmann (PAREXEL Germany and current board member for CDISC) is forming a Europe CDISC Coordinating Committee. An analogous Japan CDISC Coordinating Committee is in progress.

CDISC now has 85 corporate sponsors and members and is continuing to make progress towards its goal of creating a global, harmonized CDISC standard through the concerted efforts of its many participating volunteers. CDISC is also working towards harmonizing standards with Health Level 7 (HL7), a Health and Human Services (HHS)-recognized standards development organization with which CDISC has a formal relationship.

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 information about CDISC, including CDISC educational courses and CDISC membership, visit the website at www.cdisc.org. The CDISC models are open and can be accessed via the CDISC website: http://www.cdisc.org/standards/index.html. Additional information and tools are available through the CDISC Members area on the website. For more information about the activities of the Regulated Clinical Research and Information Management (RCRIM) Technical Committee, which is jointly chaired by representatives of HL7, FDA and CDISC, visit http://www.hl7.org.

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