Companies Integrate To Develop Flexible Patient Randomization In EDC Platform For Clinical Trials

Cambridge, MA - Medidata Solutions Worldwide and Cytel Inc. 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(R) 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(R). 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 cutting-edge 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."

SOURCE: Medidata Solutions Worldwide