For Immediate Release
Contact: Ronny Schnel
310-377-7517
rkschnel@criteriuminc.com
October 12, 2004
(SARATOGA SPRINGS, NY, October 1, 2004) Criterium, Inc., a global technology-based contract research organization, which has been providing creative clinical-research solutions for more than 13 years, announces today that they have completed an international clinical trial and report for FDA submission in record time.
This recent accomplishment is the result of a study Criterium, Inc. conducted in South Africa beginning late in 2003. This study was completed in the southern hemisphere, from November to February providing its client a 3-4 month advantage had the study been conducted in the United States. Although Criterium, Inc. has conducted several international trials and has been using state of the art technology for over a decade, this was the first time that South African sites and a naïve patient population had applied technology to produce such an outstanding success.
Since opening an office in South Africa, Criterium, Inc. has been very successful integrating innovative technology with experienced investigative sites to produce an ideal clinical trial situation. “South Africa’s patient recruitment statistics are among the highest in the world. English is widely spoken and understood, infrastructure is available to utilize technology if only the sponsors would provide it, costs are comparable and/or lower, and data collected from trials conducted in South Africa have significantly contributed to FDA approvals,” explains Lawrence Reiter, M.Sc., Managing Director, South Africa, Criterium Clinical Research Pty. Ltd., a division of Criterium, Inc.
To meet the needs for collecting high quality data, Criterium, Inc. used the IVR (Interactive Voice Response) system. This allowed data management headquarters to monitor the patients daily. Well over 20,000 calls were made to the IVR in two and a half months with compliance reaching a high of 92%. “This experience is another example of the benefits of Criterium’s application of multiple technology tools to implement Remote Study Management; we are successful in a variety of clinical settings, therapeutic areas, and geographical locations to save time and cost,” says John M. Hudak, President and Founder of Criterium, Inc.
With headquarters in Saratoga Springs, N.Y., and offices in Rolling Hills Estates, Calif., and Johannesburg, South Africa, Criterium is a global technology-based contract research organization that provides innovative clinical research solutions to the biopharmaceutical, pharmaceutical, medical-device, and CRO industries. Criterium manages the entire clinical research process from initial planning to approval. All 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 Criterium, visit www.criteriuminc.com or call (518) 583-0095
