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. This achievement emphasizes Clario's continued leadership in defining responsible, high-quality, and secure AI practices for clinical research.
Clario Achieves ISO 42001:2023 Certification
Clario, a major provider of endpoint data solutions for clinical trials, has been certified to the ISO 42001:2023 standard for its artificial intelligence (AI) management system. This certification, audited by Schellman, highlights Clario's commitment to responsible, high-quality, and secure AI practices in clinical research, making it among the first to comply with this international standard for AI governance.
Setting Industry Standards with Triple ISO Certification
Clario stands out as the first clinical trial vendor to achieve ISO 42001, augmenting its existing ISO 27701 (data privacy) and ISO 27001 (information security) certifications. This unique combination, held by fewer than 15 companies globally across all sectors according to Schellman, solidifies Clario's pioneering role in ensuring robust data integrity and patient privacy within its AI frameworks.
Leadership Perspective on AI Responsibility
Chris Fikry, M.D., Clario's CEO, expressed that the ISO 42001 certification validates the company's dedication to responsible and innovative AI use in clinical trials. He emphasized this achievement as a critical step in establishing industry benchmarks for secure, scientifically rigorous, and trusted AI solutions for clients and partners.
Impact of AI on Clinical Data Processing
Clario handles over 6 million data points monthly from various clinical technologies. Since 2018, its AI models have been instrumental in optimizing efficiency, data precision, privacy, and scientific interpretation, playing a crucial role in the vast amounts of data collected for drug development.
Future-Proofing with Integrated Security and Technology
Jay Ferro, Chief Information, Technology, and Product Officer, stated that Clario's adherence to international ISO standards guarantees accurate, reliable, and secure data handling throughout the drug development lifecycle. He noted that the combined ISO 42001, 27701, and 27001 certifications distinguish Clario as a trusted partner, prepared to adapt to emerging AI regulations and cybersecurity frameworks.
Driving Confidence and Better Patient Outcomes through AI
Marko Topalovic, Chief AI Officer, detailed Clario's responsible-use framework for AI and machine learning (ML), designed to deliver regulatory-grade, longitudinal insights. With over 120 AI models deployed more than 1,600 times, the focus remains on enhancing data quality, safety, precision, and platform efficiency to accelerate trust and improve patient outcomes globally.
About Clario's Role in Clinical Trials
Clario is a premier provider of endpoint data solutions for the clinical trials industry. It specializes in generating high-quality clinical evidence through comprehensive solutions including medical imaging, eCOA, precision motion, cardiac, and respiratory endpoints. With over 50 years of experience, Clario has supported more than 30,000 clinical trials in over 100 countries and has contributed to over 70% of all FDA drug approvals since 2015.
