Criterium, Inc.

Contact Information

John M. Hudak, President & Founder
Ronny Schnel
Executive Director Business Development/Client Services
Criterium, Inc.
358 Broadway, Suite 201
Saratoga Springs, NY 12866

Company Overview

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 management, 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. We are project management experts!

Criterium’s staff have the ability to handle large-scale clinical projects from site recruitment to patient enrollment, from study initiation to study closure, and from data acquisition to data reporting – all while providing the personal attention often lacking in larger CRO’s. 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 centrally manage studies, allowing CRAs to manage more sites, more efficiently; Criterium 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 established 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. Get To Know Us!

Products and Services

Criterium provides full clinical research and development services to Pharmaceutical, Biotechnology, and Medical Device companies in prospective Phases I-IV, Therapeutic Equivalence studies, patient registries, observational and retrospective studies and preference, satisfaction and resource utilization surveys. Our translational science model allows us to provide expertise and innovative solutions for the rapid design, implementation, management and completion of complex cancer trials.

StudyControl™ was developed in 1997 as Criterium's proprietary 21 CFR Part 11 compliant comprehensive application for organizing, cleaning and managing clinical trial data for any clinical study environment. 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.

EDC (Electronic Data Capture) is one of the tools that Criterium uses to acquire and process real-time clinical data. Because clients have different needs and budgets, and often choose the EDC vendor for their studies, our sophisticated data management staff has experience with a variety of EDC vendor systems. The common factor in all these systems is that our workflow maximizes the facility of receiving real-time data so we can provide real-time information to clients.

TeleDiary™ brand of ePRO is Criterium's original IVR telephony service that collects data directly from patients. In conjunction with our IVR and evolved IWR services, Criterium provides real-time data tracking for patient recruitment, registration, randomization, patient diaries, and CTM management. The advent of IWR allows entry of information using computers on the most prevalent bring-your-own-devices (BYOD), i.e., Apple and Android smartphones and tablets. Remote data management using either stand alone or integrated IVR, IWR and EDC combines the process of collection, correction, and database locking, as well as a metadata audit trail not possible with paper CRFs or patient diaries. IWR Wed Board reporting includes smart phone or tablet component providing further convenience to all trial collaborators to securely access real-time data via the web. Criterium has been implementing technology in clinical trials since 1991.

Through the implementation of StudyControl™, IVRS & IWRS, automated fax, web-enabled forms and online web-board reporting, Criterium manages clinical data every day for rapid data editing, timely decision making, and on-time release of the final deliverable – usually a final study report. Our extensive use of real-time systems also allows us to manage field staff and control costs of clinical studies world-wide.

Global Markets Served:

  • North & South America
  • Europe & Russia
  • South Africa
  • South East Asia
  • India
  • Israel
  • Australia/New Zealand

Single Service, or Complete Management: Criterium concentrates on each detail of a clinical trial and coordination of your entire clinical development program.

  • Clinical Drug, Biologics and Medical Device Development Planning
  • Bioequivalence with Clinical Endpoint/Therapeutic Equivalence Studies
  • Oncology Specialty CRO: Research Consortia for GI, Myeloma, Lung & Breast Cancers
  • Translational Science
  • Advisory Panel of KOL’s at major academic institutions
  • Protocol Development
  • Site Solicitation and Qualification
  • Clinical Trial Monitoring
  • Project Management
  • Remote Study Management / Real-Time Data Management
  • Electronic Data Capture (EDC) using various commercial systems.
  • IVR & IWR: Interactive Voice Response, Interactive Web Response Services and Web Board Reporting (IxRS)
  • IVRS-based Interactive Patient Diaries (TeleDiary TM brand of ePRO)
  • IWRS-based applications programmed for Computers and Apple and Android smartphones and Tablets
  • CRF Design and Distribution
  • Database/SAS Programming
  • Data and Report Management, Statistical Analysis
  • Protocol, Statistical and Final Report Writing
  • Regulatory Affairs and Agency Submissions Globally
  • Risk Management
  • MedDRA and WHO Drug Coding
  • CTM Management
  • Medical Writing

Locations Around the Globe

Criterium is headquartered in Saratoga Springs, New York and has offices in California, South Africa, and India. These international locations coupled with real-time data capture, management and reporting enable Criterium to provide time- and cost-efficient study management and monitoring for our clients 24/7.

Other Information

Proprietary Site/Investigator Registration database:

Contact Information

John M. Hudak, President & Founder
Ronny Schnel
Executive Director Business Development/Client Services
Criterium, Inc.
358 Broadway, Suite 201
Saratoga Springs, NY 12866

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