Achieving Standards Set by Leading Working Groups
Our central statistical monitoring technology was developed in accordance with working groups such as the ICH and ISO, signifying not only compliance with regulatory requirements but also alignment with GCP best practices and a dedication to ongoing innovation.
ICH Guidance
ICH guidance is generally adopted by foremost regulatory authorities, including the FDA, EMA, MHRA, and PMDA, which makes them crucial directives for CluePoints clients. ICH E8 (R1) is a valuable resource for understanding the planning, design, and management of clinical development in biopharmaceutical products. It emphasizes the importance of carefully designing clinical research to ensure operational feasibility and quality outcomes, aligning with the Quality by Design (QBD) approach. This approach overlaps with RBQM, as outlined in the ICH E6 (R2) guidance for GCP. ICH E6 (R3) will replace R2 and further elaborate on both RBQM and QBD principles. This GCP Principles document is considered overarching guidance and will be accompanied by two Annex documents. Annex 1 will be published first, focusing on interventional trials. Annex 2 will follow, concentrating on non-traditional interventional trials. This is expected to address adaptive and decentralized trial designs.
ISO Guidance
ISO 14155:2020 stands as the most recent iteration of the ISO standard governing clinical investigations concerning medical devices for human subjects. It outlines the regulatory stipulations guiding the planning, execution, documentation, and risk-focused surveillance of such clinical investigations. Notably, for CluePoints clients, ISO 14155:2020 accentuates the importance of clinical quality management, risk-based monitoring and related plans, increased statistical requirements, and clinical investigation audits within this framework.Â
