Clinical Data Interchange Standards Consortium Incorporated as Non-Profit Organization; Industry Seeks to Streamline Electronic Data Management For Drug Development Process.

Business Editors & Health/Medical Writers

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AUSTIN, Texas--(BW HealthWire)--June 6, 2000

The Clinical Data Interchange Standards Consortium (CDISC) has incorporated as a non-profit organization, supported by corporate members from the pharmaceutical product development industry. CDISC, which was originally a grass-roots effort and then a Special Interest Advisory Committee of the Drug Information Association (DIA), is an open, multidisciplinary organization with a mission to lead the development of global, vendor-neutral, platform-independent standards to improve data quality and accelerate product development in the industry.

The board of directors of CDISC is comprised of those who served as the CDISC Steering Committee for the past two years: David Christiansen, Ph.D., principal statistician, Genetech, Inc.; Kaye Fendt, MSPH, former FDA liaison to CDISC; Wayne Kubick, MBA, principal, PROsys LLC; Rebecca Kush, Ph.D., vice president and chief scientific officer, NextPhase International (CDISC president); and Judith Sromovsky, MS, director, Clinical Trial System Standards, Merck & Co., Inc.(CDISC treasurer). James Becker, president, PHT Clinical Networks, is the CDISC acting clerk/resident agent in Massachusetts.

"Since CDISC was conceived three years ago, there has been an increasing awareness that only standardizing within a company is not optimal. The faster we can all speak the same language electronically, the better this entire drug development process will be in the future," said Judy Sromovsky of Merck & Co., one of the initial corporate members of CDISC. "CDISC is a logical step for the pharmaceutical companies to achieve industry standards."

The goal of the new Austin, Texas-based organization, is to dramatically improve the exchange of data within and between companies. Currently, data is collected from patients by clinical trial site managers, monitored by sponsoring companies, processed, formatted and analyzed by data managers, statisticians and clinicians, and presented to regulators using a variety of incompatible data collection tools, database structures and computer languages that often cannot manage or integrate data consistently.

"Developing new drugs to improve the lives of patients has always been a costly, slow and laborious process," said Rebecca Kush, founder and president of CDISC. "Standards for electronic data interchange hold the potential to make information management faster, less expensive and more accurate. The industry has acknowledged that we need uniform standards so that pharmaceutical companies, clinical trial managers, physicians and software developers can communicate efficiently, from the information-gathering stage through regulatory submission and approval."

Dr. Kush will chair a session addressing industry representatives on the CDISC mission and progress on June 15 at the Drug Information Association convention in San Diego. For more information, please see the CDISC website at www.cdisc.org, or contact Dr. Kush at 512-791-7612, or via email at [e-mail]; or Jim McManus at Schwartz Communications, 781-684-0770, or via email at [e-mail].