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Criterium, Inc.

Criterium, Inc. is a full-service contract research organization (CRO) founded in 1991, providing clinical trial services and technology-driven data solutions to pharmaceutical, biotech, and medical device companies worldwide.

Last updated September 26, 2026

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Overview

Criterium, Inc. is a privately held, full-service contract research organization (CRO) headquartered in Saratoga Springs, New York, United States. Founded in 1991 by John Hudak, the company was established to address the need for more consistent, technology-based support of medical research. Its early innovation centered on the use of Interactive Voice Response (IVR) to create a system for real-time collection of patient diary data, which eliminated transcription errors and ensured accurate reporting. Over the decades, Criterium has expanded its technological capabilities to include Electronic Data Capture (EDC), Interactive Web Response (IWR), and Electronic Patient Reported Outcomes (ePRO), enabling tighter control of studies, cost-effectiveness, and adherence to timelines. The company provides clinical trial services to pharmaceutical, biotechnology, and medical device companies, as well as to government agencies and non-governmental organizations. Its service offerings include clinical trial management, CORE Science Solutions, a unique Centralized Network Model (CNM) for translational research, and Criterium Technology, which encompasses IVR/IWR and ePRO systems. Criterium positions itself as a "Premier Hands-on CRO" and a "Collaborative CRO," emphasizing personal attention, fewer levels of management, and rapid responsiveness to client requests. Criterium has expanded its global reach over time, with operations or partnerships in Canada, India, South Africa, the European Union, Russia, Australia, and New Zealand. The company has also developed Oncology Specialty Research Consortia groups in conjunction with major universities and nationally recognized institutions, making it a notable research network in the United States and Canada. Its successful FDA audits have reinforced its reputation for comprehensive capabilities. Criterium continues to be active in the clinical research industry, providing technology-enabled trial solutions and therapeutic expertise across areas such as oncology, cardiovascular disease, Parkinson's disease, traumatic brain injury, and rare diseases.

History

Criterium, Inc. was founded in 1991 by John Hudak. The company was created to fill a need for more consistent, technology-based support of medical research. Hudak's initial innovation was the use of Interactive Voice Response (IVR) to create a new system for the real-time collection of patient diary data. This system eliminated transcription errors and ensured accurate reporting, setting the foundation for Criterium's technology-driven approach. Over the following decades, Criterium widened the use and scope of state-of-the-art technologies to connect all stakeholders to real-time data sources. In addition to IVR, these technologies came to include Electronic Data Capture (EDC), Interactive Web Response (IWR), and Electronic Patient Reported Outcomes (ePRO). Obtaining data in real-time enabled tighter control of studies, ensured cost-effectiveness, and helped adherence to timelines. Criterium expanded into global markets, establishing a presence in Canada, India, and South Africa, and forming partnerships in the European Union, Russia, Australia, and New Zealand. This created worldwide trial accessibility for clients and patients alike. The company also successfully underwent FDA audits, which provided sponsors with confidence in its comprehensive capabilities. A significant development was Criterium's expansion into Oncology Specialty Research Consortia groups in conjunction with major universities and nationally recognized institutions. This made Criterium a definitive research network in the United States and Canada, with premier qualified sites available instantly for recruitment. Today, Criterium continues to operate as a full-service contract research organization, dedicated to providing efficiency and expertise in clinical trial services to pharmaceutical, biotechnology, and medical device companies, as well as to corporations, government agencies, and non-governmental organizations throughout the world. The company emphasizes its "hands-on" and collaborative approach, with a long-time dedicated executive team.

  • 1991

    Criterium, Inc. founded by John Hudak.

  • Introduced IVR system for real-time patient diary data collection.

  • Expanded technology to include EDC, IWR, and ePRO.

  • Expanded into global markets: Canada, India, South Africa; partnerships in EU, Russia, Australia, New Zealand.

  • Formed Oncology Specialty Research Consortia with major universities and institutions.

Products and positioning

Premier hands-on CRO; collaborative CRO with fewer management levels and rapid responsiveness; technology-driven clinical trial innovation.

  • Clinical Trial Services

    Full-service clinical trial management for pharmaceuticals, biotech, and medical devices.

  • CORE Science Solutions

    Unique Centralized Network Model (CNM) for translational research.

  • Criterium Technology

    IVR/IWR & ePRO systems for seamless interfacing with ancillary support technologies.

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