CompleWare Announces the Release of RandomizeIT

Clinical Trial Staff Can Now Enroll and Randomize Subjects Using Either the Telephone or the Internet

Iowa City, Iowa -- December 16, 2002 -- CompleWare® Corporation today announced the release of RandomizeIT, a new software application that allows clinical trial site staff to enroll and randomize subjects in pharmaceutical trials using either the telephone or the Internet.

Many studies today exclusively use interactive voice response system (IVRS) technology to enroll and randomize subjects to treatment groups in multi-center clinical trials.

RandomizeIT is the 'next generation application that permits entry of subject data using either the Internet or the telephone," says John Weiler, MD, CompleWare President. Sites with Internet access may enter enrollment data and randomize a subject in a few seconds rather than having to enter data using cumbersome techniques required when the telephone is used. The telephone is still an option for sites that want to use it."

Once the subject is enrolled the site may record that the subject was a screen failure or randomize the subject to treatment or terminate the subject from the study. Sponsors and monitors can view and print enrollment logs and randomization data online 24 hours a day, 7 days a week from the RandomizeIT web site. Randomization confirmations can also be sent via email and by FAX if requested.

RandomizeIT simplifies the work of the site, monitor, contract research organization and sponsor," Weiler said. With all data online, users with rights to view data can see how the study is progressing in real time. RandomizeIT eliminates the necessity for faxed enrollment logs."

Sponsors with sophisticated randomization schemes can imbed them in the software to allow sites to stratify subjects at the time of randomization. RandomizeIT is designed to be compliant with FDAs 21 CFR Part 11 requirements for electronic records.

RandomizeIT is the newest member of the WebCRF® family of CompleWare products and services. A demonstration version of RandomizeIT is at http://www.compleware.com/webrandomizeit/

About CompleWare
CompleWare Corporation, based in Iowa City, Iowa, focuses on development of innovative software to capture clinical research data electronically with the highest quality, speed and ease of data entry. CompleWare is a pioneer in the electronic data capture industry, having provided services to pharmaceutical sponsors for 17 years. The first CompleWare IVRS software application was introduced in 1985. Through its CompleSoft division, CompleWare provides licensed software applications for use in the pharmaceutical industry. For more information, please visit www.compleware.com or call 319-338-8888 or (toll free) 800-369-8888.
CompleWare, CompleSoft and WebCRF are registered trademarks or services marks and RandomizeIT is a service mark of CompleWare Corporation.

CompleWare Media Contacts:
Kay Weiler
Vice President
319-388-3888
Email: kweiler@compleware.com

Mark Fullenkamp
Marketing Director
319-338-8888
Email: mfullenkamp@compleware.com