Criterium, Inc. is a full-service, global contract research organization that offers a unique mix of high-quality clinical research services, real-time data acquisition and personalized communication processes to manage a trial from initial planning to approval , on time and on budget. Founded in 1991, the Criterium team provides a high level of therapeutic expertise, high-quality clinical development services, and highly efficient processes to the pharmaceutical, biotechnology, and medical-device industries.

Criterium’s staff have the ability to handle large-scale clinical projects from site recruitment to patient recruitment, from study initiation to study closure, and from data acquisition to data reporting – while providing the personal attention often lacking in larger contract research organizations. With fewer levels of management, Criterium’s staff is able to respond quickly to a client’s request and initiate action in real time, without having to consult a committee. Using innovative products to improve efficiencies, without compromising the quality of data, Criterium’s staff can centrally manage studies thus allowing CRAs to manage more sites, more efficiently in the field. Criterium’s monitors can manage twice the number of sites that traditional monitors can handle. They are all trained to FDA, ICH and GCP guidelines. Criterium’s experienced and stable staff gives all projects, regardless of size, the attention they require.

At Criterium, who we are, what we do, and how we do it are centered on our service reputation: an uncompromising “Always Delivers” attitude in everything we do.

Criterium provides clinical research and development services to Pharmaceutical, Biotechnology, and Medical Device companies in Phases I-IV, Therapeutic Equivalence studies, patient registries, and preference, satisfaction and resource utilization surveys.

Study Control© is Criterium's proprietary 21 CFR Part 11 compliant comprehensive application for organizing, cleaning and managing clinical trial data for any clinical study environment - from small single site operations to worldwide organizations. It provides a centralized clinical trial data management environment that allows a compliant, standardized methodology for processing, validating and presenting real-time information to clinical trial management and monitors. Study Control© is the culmination of over 10 years experience in automated clinical trials using proven technological platforms and methodologies.

TeleDiary©, Criterium's IVR service, provides real-time data tracking for patient recruitment, registration, randomization, patient diaries, and CTM tracking. Remote data management using IVR combines the process of collection, correction, and database locking, as well as provides an audit trail not possible with paper patient diaries. Criterium has been implementing IVR in clinical trials since 1991.

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Through the implementation of IVRS, automated fax, web-enabled forms and online reporting, Criterium manages the data every day for timely decision making, rapid data editing and on time delivery of the final deliverable – usually a final study report. The use of real-time systems also allows us to manage the field staff to keep control of costs. Criterium sets up and manages clinical studies around the world using our automated systems.

• North America
• South America
• Europe
• Africa
• India
• Australia/New Zealand

Criterium concentrates on each detail of a clinical trial. Whether you require a single service, or complete management and coordination of your entire clinical development program.

• Clinical Drug, Biologics and Medical Device Development Planning
• Protocol Development
• CRF Design and Distribution
• Site Solicitation and Qualification
• Clinical Trial Monitoring
• Project Management
• Remote Study Management Using Real-Time Data Management Tools
• Electronic Data Capture (EDC)
• Interactive Voice Response Services (IVRS)
• IVRS-based Interactive Patient Diaries (TeleDiary©)
• Data and Report Management, Statistical Analysis
• Protocol, Statistical and Final Report Writing
• Regulatory Affairs and Agency Submission
• Risk Management
• MedDRA and WHO Drug Coding
• CTM Management
• Medical Writing
• Database/SAS Programming
• Bioequivalence/Therapeutic Equivalence Studies
• PK, BE and Phase I study design, placement, management and completion

Criterium is headquartered in Saratoga Springs, New York and has offices in California, South Africa, India, and The Netherlands. These international locations couple with real-time data capture, management and reporting enables Criterium to provide time- and cost-efficient study management and monitoring for our clients.

Site/Investigator Registration: www.criteriuminc.com

Contact Information

Criterium, Inc.
Ronny Schnel, Executive Director Business Development/Client Services
734 Silver Spur Rd., Suite 203
Rolling Hills Estates, CA 90274 USA
Phone: 310-377-7517
Fax: 707-929-0792
E-mail:

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