Criterium Kicks Off 2-Year Oncology Study In India

Saratoga Springs, NY-May 1, 2008- A meeting at The Mumbai Hyatt Hotel hosted by Criterium Inc. (www.criteriuminc.com) and The Thrombosis Research Institute (TRI; www.tri-london.ac.uk/) of London, England, assembled more than 60 investigators from India and marked the kick-off for a 2-year Phase IIIB oncology study. This one day meeting prepared investigators to conduct this major study of the incidence of symptomatic venous thrombo-embolism (SVTE) events in patients being treated for gastric cancer. Criterium India, Criterium CorporateManagement, and TRI management presented their expectations to the investigators, further solidifying the Criterium–Thrombosis Research Institute site team.

In this study Criterium is providing Indian regulatory expertise, recruiting sites that will screen, enroll, register, and randomize 740 patients at investigational sites representing every region in India, monitoring the study, designing and validating the case report forms, managing and analyzing the data, and writing the final clinical study report.

Criterium’s New York headquarters will coordinate real-time receipt and management of the study data using StudyControl™, Criterium’s innovative proprietary technology that integrates multiple technologies with Criterium’s unique workflow for seamless and timely reporting of results. Enrollment, randomization, safety, and efficacy information will be available to the Criterium–Thrombosis Research Institute team members in real-time as the data are received from the sites immediately after each patient visit.

“The meeting was a rousing success; the sponsor was extremely happy with the turnout and the quality of the presentations,” noted Eduardo F. Jahn, associate director of operations for Criterium and projectmanager for this study. “This is a tribute to the entire staff of Criterium India which took the lead on all the many details involved in this investigator meeting and provided an environment in which investigators could sharpen their understanding of this landmark study of SVTE events in patientsundergoing treatment for gastric cancer. Our team at Criterium India made my job easy.”

StudyControl in combination with on-the-ground Criterium staff in India allow headquarters staff in Saratoga Springs, NY, to manage the study remotely.

Dr. Janice Manisha Maganji, clinical trials manager for The Thrombosis Research Institute, commented, “It is very difficult for me to trust somebody or delegate a job that I envision to be done with a certainquality of perfection with correct, timely flow of events. It takes time for me to be confident and tell myself, ‘my study is in safe hands.’ With Criterium, my confidence has gone from strength to strength. Now I tell myself and my colleagues, ‘Our trial is in safe, efficient, and reliable hands.’ I can’t wait to initiate another and bigger project with them.”