NEW MEMBERSHIP OPPORTUNITIES FOR THE CLINICAL DATA INTERCHANGE STANDARDS CONSORTIUM (CDISC)

Austin, TX - 6 July 2001 - The Clinical Data Interchange Standards Consortium (CDISC) announced its new CDISC Membership Structure today. The new structure is designed to provide expanded opportunities for companies of every size - large and small, to demonstrate their commitment to the CDISC mission. CDISC is an open, multidisciplinary, non-profit organization committed to the development of worldwide industry standards to support the electronic acquisition, exchange, submission and archiving of clinical trials data and metadata for medical and biopharmaceutical product development.

A volunteer organization for over two years, CDISC was incorporated in February 2000 and currently has 47 Corporate Sponsors and three Corporate Members from many areas within the clinical trials industry. Membership and Sponsorship contributions to CDISC are used to fund the operations of the organization and for leadership of the working teams developing the clinical trial data models.

To date, there have been two mechanisms for corporations to join CDISC: Corporate Sponsorship and Corporate Membership. Benefits of CDSIC Corporate Sponsorship include:

• Early access to and influence on the data models
• Influence on the strategic direction of CDISC through voting participation on the Industry Advisory Board
• Being at the cutting edge of industry standards development
• Access to the members-only section of the website to review team progress
• Discounts at educational programs sponsored by CDISC
• Media partnership opportunities

Benefits of CDISC Corporate Membership include all of the above, with the exception of a seat on the Industry Advisory Board.

Recently a Membership Task Force was initiated to review the current membership structure and recommend appropriate modifications. Representatives from current Corporate Sponsors and Members, and from the CDISC Participants pool, met to share ideas and visions for membership in CDISC. On 25 June, the CDISC Board of Directors approved the new structure developed by the task force.

"The Membership Task Force agreed that, for the most part the original structure was quite balanced and appropriate, with the exception of including a mechanism that would provide smaller or start-up companies a reasonable option for joining CDISC," said Scott Neuville of iBiomatics, Director on the CDISC Board and leader of the Membership Task Force. "The CDISC Industry Advisory Board expressed an opinion early on that, although individuals are certainly welcome to participate in CDISC efforts, standards development is a corporate commitment. Hence, we feel that we must provide a mechanism for corporations of all sizes and types to join CDISC."

As of 1 September 2001, the contribution for Corporate Membership will be an annual rate of $10,000 for companies with 1000 or more employees, $7,500 for companies with 500-999 employees, and $5,000 for companies with 1-499 employees. To become a Corporate Sponsor, companies must pay the annual Corporate Membership dues and also pay a one-time Sponsorship contribution of $40,000 for companies with 1000 or more employees, $15,000 for companies with 500-999 employees and $10,000 for companies with 1-499 employees. This one-time Sponsorship contribution will be paid along with the first year's membership dues at the onset of becoming a Corporate Sponsor. Sponsors will then pay their annual rate for renewal.

In addition, the CDISC Membership Task Force opened up a new level of support of CDISC with an Associate Membership, which became available on 1 July. This level of membership was developed to enable smaller or start-up companies to support the efforts of CDISC. The Associate Membership is open to companies with fewer than 100 employees, academic entities or non-profit organizations. The annual contribution is $2,000. Along with this lower level of monetary contribution, Associate Members will contribute services to CDISC. These services may include volunteering to be on CDISC teams or task forces, documentation, or other services suited to the capabilities of that company. Associate Members receive the same benefits as Corporate Members.

"We were pleased to be part of the Task Force that developed this new membership option for companies such as ours," said Dr. Matthew Whalen of Chesapeake Research Review, a professional services firm with an Institutional Review Board (IRB). "Although we have been actively involved with CDISC for quite some time, we now have a means through which we can formally demonstrate and be recognized for our support of this organization and its mission to develop global, vendor-neutral standards to improve data quality."

For more information, please see the CDISC website at www.cdisc.org, or contact one of the representatives of CDISC listed above.

###