For Immediate Release
Contact: Ronny Schnel
310-377-7517
rkschnel@criteriuminc.com
June 2005
(SARATOGA SPRINGS, NY, June 2005)- Criterium, Inc., a full-service technology-based contract research organization, which has been providing creative clinical-research solutions for more than 14 years, announced today that they have successfully taken part in bringing another drug to FDA approval.
Criterium remotely managed 35 sites and provided data management for this clinical trial that enrolled 540 patients within 11 months. Data was collected across the United States using Criterium’s fax- form system as well as the Tele-DiaryTM IVR system. During the study, patients were asked to call the IVR to complete a series of questions regarding their symptoms for a period of 7-days. Patient compliance to the IVR diary was nearly 90% at the close of the trial.
“We are very proud of the processes we have built around various
technologies to service our clients,“ says Founder and President,
John Hudak. “It is our goal to deliver every project, to every
client, done correctly and on time. At the end of the day, the real
validation of
our systems is regulatory approval of the data we have collected and
submitted to support our client’s product.”
Criterium has participated in over a dozen women’s health studies including bacterial and fungal infections, hormone replacement, breast cancer, contraceptives, menorrhagia due to von Willebrand’s disease and urinary incontinence. During the last ten years, Criterium has used technology-enhanced services to complete these studies ahead of schedule and to provide key data for successful NDAs and NDA supplements.
Criterium takes pride in utilizing systems that promote a high rate of patient compliance and as a result, provide good quality data.
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 offers a unique mix of high-quality, innovative clinical-research solutions and communications tools to manage the entire clinical-research process from initial planning to approval. The biopharmaceutical, pharmaceutical, medical-device, and CRO industries benefit from Criterium’s expertis e, 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.
