Ssg Medical Becomes First Domestic CRO to Obtain ISO/IEC 42001 AI Management Certification
The certification marks the first time a domestic CRO has met the international standard for AI governance, formalizing how the company uses AI in drug development modeling without adding new regulatory risk.
Reporting from 1 sources: ASCII.jp.
Ssg medical Co., Ltd., a Kumamoto-based CRO specializing in modeling and simulation for drug development, has obtained ISO/IEC 42001 certification for its AI management system, effective June 12, 2026. The certification, issued in 2023, establishes criteria for responsible AI use. The company already holds ISO/IEC 27001 for information security.
Ssg medical, a contract research organization focused on modeling and simulation for drug development, has become the first domestic CRO to obtain ISO/IEC 42001 certification for its AI management system. The certification, effective June 12, 2026, covers the company's use of AI in its core M&S services and related IT work that supports quantitative decision-making in drug development. The standard, issued in 2023, provides a framework for establishing, maintaining, and continuously improving an AI management system. Ssg medical already holds ISO/IEC 27001 for information security and says the new certification ensures safe handling of confidential data in pharmacokinetic and pharmacodynamic analysis.
Synthesized by Yomimono from the 1 cited source below, including Japanese-language reporting where cited, then editorially reviewed before publishing.