ISO/IEC 27001 is an international standard that defines requirements for establishing, operating, and improving an information security management system.
It focuses on systematic risk assessment and the implementation of controls to protect sensitive data and critical information assets. In clinical research, ISO/IEC 27001 alignment supports strong safeguards for participant data, electronic trial systems, and regulated documentation repositories. Certification signals that security practices are governed, monitored, and continuously improved through an auditable program. This can strengthen sponsor confidence and support due diligence for vendors handling clinical trial data.