Medidata Solutions and Cytel Inc. First to Integrate Flexible Patient Randomization in EDC Platform for Clinical Trials

June 18, 2006

Applied Clinical Trials

Applied Clinical Trials, Applied Clinical Trials-06-19-2006, Volume 0, Issue 0

Combined Advanced Technologies Enable Both Traditional and Adaptive Clinical Trials

Debuting at DIA Annual Meeting in Medidata Booth # 229

New York, NY, and Cambridge, MA, June 19, 2006-Medidata Solutions Worldwide and Cytel Inc. today announced a major advancement toward dramatically increasing efficiencies in the biopharmaceutical clinical development process. The companies have combined their respective expertise in electronic data capture (EDC) and flexible patient randomization to offer clinical study sponsors the ability to, for the first time, randomize patients in all types of trials-both traditional and adaptive-directly through an EDC system.

Medidata and Cytel have successfully integrated Cytel's FlexRandomizer® engine into Rave, Medidata's popular Web-based EDC system. Most clinical trials today use multiple data entry tools, including one tool for capture of the majority of clinical trial data and another for patient randomization. Now, both of these tasks can be completed through a single interface provided by Medidata Rave®. Randomization and eligibility criteria are checked uniformly across all investigator sites, accrual of study patients is monitored in real-time, treatments can be adjusted to patients' dose responses or other adaptive algorithms can be applied, and all randomization data is securely maintained within one system.

These features result in increased efficiencies in study conduct, reduced costs, and most importantly, increased patient safety. Unifying EDC with flexible randomization offers even greater advantages in facilitating and implementing adaptive clinical trial methodologies.

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