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

FOR IMMEDIATE RELEASE
 
Medidata Solutions and Cytel Inc. First to Integrate Flexible Patient
Randomization in EDC Platform for Clinical Trials
Combined Advanced Technologies Enable Both Traditional and Adaptive Clinical
Trials; Debuts 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.

“Sponsors have realized the benefit of Medidata Rave in providing real-time visibility and early insight into clinical data and are now looking to evolve their use of EDC to enable adaptive clinical trials,” said Glen de Vries, chief technology officer at Medidata Solutions. “Cytel’s dynamic randomization engine provides Rave users the flexibility to not only perform randomization for traditional trials, but to also quickly and reliably implement adaptive clinical trial designs.”

“We are very pleased to be working with Medidata Solutions to provide a cuttingedge solution to enable more efficient clinical trials,” said Cytel’s President of Pharmaceutical Research Dr. Jerald Schindler. “Cytel has become a leader in helping companies plan and monitor adaptive clinical trials, while Medidata is a recognized leader in driving EDC innovation and adoption. By combining Cytel’s FlexRandomizer and adaptive trial expertise with Medidata’s Rave and clinical data management expertise, sponsors can offer sites a one-step process through a single system for patient data entry and patient randomization, enabling more efficient and flexible trials.”

This web-based platform for integrated EDC and randomization will debut at this week’s Drug Information Association (DIA) Annual Meeting. Attendees can view a demo at Medidata Solutions’ exhibit booth #229.

About Medidata Solutions Worldwide
Medidata Solutions helps the world’s leading pharmaceutical, biotechnology and medical device companies realize the maximum potential value from their clinical research investments. Working with companies large and small, Medidata Solutions helps accelerate the process of bringing life-enhancing treatments to market—on five continents and in more than 70 countries. Innovative process design, technology and services can streamline clinical trials by providing early visibility to clinical data for faster decision-making, optimized resources and lower execution risk. Medidata Solutions’ broad client base and deep clinical experience provide value for the world’s leading pharmaceutical, biotechnology and medical device companies, expertise in more than 20 therapeutic areas, projects in Phase I, II, III, IV, registries and surveillance, and studies with thousands of investigators and tens-of-thousands of subjects. To learn more about Medidata Solutions, please visit www.mdsol.com.

About Cytel
Cytel Inc. (www.cytel.com) is a leading provider of clinical trial consulting services and specialized statistical software for the bio-pharmaceutical, medical device, academic, and government research markets. Cytel’s unique expertise in adaptive, flexible clinical trial designs enables trial sponsors to improve the efficiency and success rate of the drug development process. Additionally, Cytel’s East® software suite is used by hundreds of biostatisticians and clinicians in industry, academia, and the FDA to design, monitor and simulate group sequential and adaptive clinical trials.

Contact for Medidata Solutions:
Susan Lombardo
Lois Paul & Partners
781.782.5767
Susan_Lombardo@lpp.com

Contact for Cytel Inc.:
Michael Weitz
Cytel Inc.
617.661.2011
mike@cytel.com