Clario Leads the Way in Responsible Artificial Intelligence with ISO 42001 certification, audited by Schellman
PHILADELPHIA, Feb. 18, 2026 /PRNewswire/ -- Clario, a leading provider of endpoint data solutions to the clinical trials industry, today announced that its artificial intelligence (AI) management system has been certified to the ISO 42001:2023 standard, following a rigorous audit conducted by Schellman, a globally recognized certification body. This achievement emphasizes Clario's continued leadership in defining responsible, high-quality, and secure AI practices for clinical research.
ISO 42001:2023 certification, the first international standard for AI management systems, recognizes organizations that demonstrate robust governance, transparency, and ethical use of artificial intelligence. Achieving this certification required Clario to undergo a comprehensive evaluation process, including detailed assessments of its AI governance framework, risk management protocols, and operational controls to ensure compliance with the highest international standards.
Clario is the forerunner in achieving ISO 42001 among clinical trial vendors. This certification amplifies the company's existing certifications for ISO 27701 (data privacy) and ISO 27001 (information security), further strengthening its leadership in data integrity and patient privacy. Schellman reports that as of January 2026, across all industries worldwide, they have certified fewer than 15 companies with a unified governance framework that includes all three certifications.
"Achieving ISO 42001:2023 certification by a third-party auditor is a concrete acknowledgement of our dedication to the responsible and innovative use of AI in clinical trials," said Clario's Chief Executive Officer, Chris Fikry, M.D. "This is a pivotal milestone in Clario's journey to set industry standards for responsible AI in clinical research. Along with our ISO 27701 and ISO 27001 certifications, it demonstrates Clario's leadership in building trusted, secure, and scientifically rigorous solutions for our clients and partners."
Clinical trial sites and sponsors rely on Clario to process more than 6 million data points from ECGs, apps, imaging modalities, spirometers, and many other clinical technologies every month. Since 2018, the company has developed and deployed AI models to optimize efficiency, data precision, data privacy, and scientific interpretation of the data it gathers.
"By ensuring our technologies adhere to international ISO standards," said Jay Ferro, Chief Information, Technology and Product Officer, "we instill confidence that the data we collect is not only accurate and reliable, but also handled with the utmost care and security throughout the drug development lifecycle. The combination of ISO 42001, 27701, and 27001 is a unicorn in our industry. It sets us apart as a trusted partner in clinical research today, and future-proofs our platform so we can adapt to emerging AI regulations, data protection laws, and cybersecurity frameworks."
Clario has for several years implemented a responsible-use framework for the development and deployment of artificial intelligence, ensuring that all AI and machine learning (ML) capabilities are designed to meet regulatory-grade standards and support clinically relevant applications.
"Our AI team's mission is to drive confidence through the responsible design of advanced AI and machine learning solutions that deliver regulatory-grade, longitudinal insights in clinical trials," said Clario's Chief AI Officer, Marko Topalovic. "We have developed over 120 AI models and deployed those tools in clinical trials more than 1,600 times, while building new agentic AI tools that will define new standards in our industry. Everything we do is about enhancing data quality, safety, precision, and platform efficiency – in an accurate and ethical way. With each new model we create, we focus on accelerating trust, decision-making, and most of all, improving outcomes for patients around the world."
For more information about AI at Clario, visit clario.com/solutions/ai
About Clario
Clario is a leading provider of endpoint data solutions to the clinical trials industry, generating high-quality clinical evidence for life sciences companies. We offer comprehensive evidence generation solutions that combine medical imaging, eCOA, precision motion, cardiac solutions and respiratory endpoints.
For more than 50 years, Clario has delivered deep scientific expertise and broad endpoint technologies to help transform lives around the world. Our endpoint data solutions have supported over 30,000 clinical trials in more than 100 countries. Our global team of science, technology, and operational experts have supported over 70% of all FDA drug approvals since 2015. For more information, visit Clario.com or follow on LinkedIn.
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