An Information Security Management System (ISMS) is a formal framework of policies, procedures, controls, and monitoring used to manage and protect sensitive information.
ISMS programs typically include risk assessment, access controls, incident response, security governance, and ongoing improvement processes. In clinical research, ISMS practices help protect participant data, trial documentation, and regulated systems used for study conduct. Strong security governance reduces breach risk and supports compliance with privacy and security expectations for regulated data environments. A mature ISMS also strengthens vendor qualification and inspection readiness by demonstrating controlled, auditable safeguards.