#USA #Philadelphia #ISO 42001 #AI Management #Clario

Clario Achieves Landmark ISO 42001 Certification

In a significant development for the clinical trials industry, Clario has recently achieved certification to the ISO 42001:2023 standard, marking a milestone in the responsible use of artificial intelligence (AI). This certification, which comes after a meticulous audit by Schellman, underscores Clario's commitment to maintaining high-quality and secure AI practices crucial for clinical research.

ISO 42001:2023 is recognized as the first international standard for AI management systems. It honors organizations that demonstrate strong governance, ethical transparency, and responsible utilization of artificial intelligence. The process for Clario to reach this certification involved rigorous evaluations, assessing the effectiveness of their AI governance framework, risk management protocols, and operational controls, ensuring compliance with the highest global standards.

As a frontrunner in securing this certification among clinical trial vendors, Clario already benefits from additional certifications including ISO 27701 for data privacy and ISO 27001 for information security. These credentials collectively enhance the company’s authority in maintaining data integrity and protecting patient privacy. Notably, as of January 2026, fewer than 15 companies across various industries worldwide have achieved a unified governance framework that encompasses all three certifications, reinforcing Clario’s position as a leader in the field.

Chris Fikry, M.D., the CEO of Clario, expressed the significance of this achievement, stating, "Achieving ISO 42001:2023 certification by a third-party auditor is a concrete acknowledgment of our dedication to the responsible and innovative use of AI in clinical trials. This is a pivotal milestone in Clario's journey to set industry standards for responsible AI in clinical research."

The impact of Clario’s AI capabilities is widespread, as the company processes over 6 million data points from various sources, including ECGs, apps, imaging modalities, and spirometers each month. Since 2018, Clario has actively developed and implemented AI models aimed at enhancing operational efficiency, data precision, privacy, and scientific interpretation.

Jay Ferro, the Chief Information, Technology, and Product Officer for Clario, elaborated on the importance of these international standards: "By ensuring our technologies adhere to international ISO standards, we instill confidence that the data we collect is accurate and reliable, while also being managed with the highest levels of care and security throughout the drug development lifecycle. The combination of ISO 42001, 27701, and 27001 is a unique achievement in our industry, positioning us as a trusted partner in clinical research today and into the future."

Clario has long championed a framework for the responsible deployment of AI, ensuring that all its AI and machine learning functionalities are designed to meet rigorous regulatory standards pertinent to the clinical context. According to Marko Topalovic, the Chief AI Officer, their mission focuses on fostering trust through the careful design of advanced AI solutions that yield regulatory-grade, longitudinal insights in the realm of clinical trials.

To date, Clario has developed over 120 AI models, deploying them in clinical trials more than 1,600 times, while also creating new tools that promise to set further benchmarks in the industry. Each new model emphasizes improving the quality of data, ensuring safety, accuracy, and increasing efficiency in ways that are both effective and ethical. "Everything we do is calculated to enhance trust, expedite decision-making, and ultimately, improve outcomes for patients worldwide," Topalovic remarked.

In summary, Clario's recent ISO 42001 certification is a testament to its ongoing commitment to transforming clinical trials through responsible and innovative AI practices. With a blend of comprehensive governance and meticulous data handling, Clario continues to lead the way, ensuring that its operations align not just with current regulations but also anticipate future requirements in AI and data protection laws.

For further information on AI capabilities at Clario, visit clario.com/solutions/ai.

About Clario

Clario is a prominent provider of endpoint data solutions aimed at the clinical trials sector, focused on generating high-quality clinical insights for life sciences companies. With over 50 years of expertise, Clario’s cutting-edge endpoint technologies have been pivotal in supporting more than 30,000 clinical trials across over 100 countries, contributing significantly to FDA drug approvals since 2015. For additional details, visit Clario.com or connect with us on LinkedIn.