(May 1, 2008- Saratoga Springs, NY) – A meeting at The Mumbai Hyatt Hotel hosted by Criterium Inc. and The Thrombosis Research Institute (TRI) of London, England assembled over 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 Corporate Management, 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 for Operations for Criterium and Project Manager 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 patients undergoing 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, New York 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 certain quality 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.”
About Thrombosis Research Institute:
The Thrombosis Research Institute is a multidisciplinary organization concerned with the interrelated problems of thrombosis and atherosclerosis.
The mission of the Institute, set out at its inception in 1990 and reiterated in 1997 is: To be the leading national multi-disciplinary organization, providing excellence in thrombosis research, education and patient care by seeking deeper understanding of the molecular pathogenesis of disorders of coagulation, in order to develop new strategies to prevent and treat thrombosis.
The Institute’s activities encompass drug discovery, basic scientific and clinical research with the aims of understanding the disease process, developing novel and affordable therapies whilst identifying those most at risk at an early age so as to intervene to prevent long-term disablement and early death. For more information, see: www.tri-london.ac.uk
Criterium Inc., is a full service, global and technology driven contract research organization that offers a unique mix of high-quality, innovative clinical research solutions for the biopharmaceutical, and pharmaceutical, medical device and CRO industries. From thought to finish, Criterium provides timely and accurate clinical trial data and support services at every phase of development allowing customers to make sound and cost effective decisions about their clinical trials. Drug development companies can benefit from Criterium’s expertise, high-value services and products and high-end results. Founded in 1991, Criterium’s services are customized to fit each client’s specific needs, providing a seamless flow of data and information from the investigative site through Criterium back to the sponsor. To learn more about the Criterium Edge, visit the website. Criterium has corporate headquarters in Saratoga Springs, New York with offices in Florida, California, South Africa, India, Netherlands, Israel, Russia and Canada.
Contact: Claire R. Wynters, Public Relations