Achieving Standards Set by Leading Working Groups
Our central statistical monitoring technology was developed to support alignment with ICH and ISO guidance and standards, signifying not only compliance with regulatory requirements but also alignment with GCP best practices and a commitment to ongoing innovation.
ICH Guidance
ICH guidance is widely adopted by leading regulatory authorities, including the FDA, EMA, MHRA, and PMDA, making it highly relevant for CluePoints clients. ICH E8(R1) supports QbD through careful trial planning, design, and management. ICH E6(R3), the current Good Clinical Practice guideline, builds on these principles with stronger emphasis on proactive quality management, risk-proportionate approaches, and modern trial conduct, including interventional trials and trials incorporating decentralized, pragmatic, or real-world data elements.
ISO Guidance
ISO 14155:2026 is the current ISO standard governing clinical investigations of medical devices involving human subjects. It outlines the Good Clinical Practice requirements for the design, conduct, recording, and reporting of clinical investigations, with a focus on protecting participants and ensuring the credibility of clinical investigation results. For CluePoints clients, ISO 14155:2026 reinforces the importance of clinical quality management, risk-based oversight, statistical considerations, and clinical investigation audits within medical device research.
