Innovation & Accordance
ICH E6(R3) is now in force globally, cementing Risk-Based Quality Management (RBQM) as a core GCP requirement. CluePoints is built to operationalize every element of it, from protocol-level quality by design through centralized risk detection, site-level action, medical coding, safety review, and query detection, in one connected, inspection-ready platform. Explore how the latest regulatory guidance aligns with what CluePoints delivers in practice.
ICH & ISO Guidance
ICH E6(R3) is now in force, adopted by the EMA in July 2025 and by the FDA in September 2025, making it the active GCP standard for clinical trials globally. Together with ICH E8(R1), which underpins Quality by Design (QbD) and proactive risk planning, these guidelines require documented, proportionate, end-to-end oversight across every trial. ISO 14155:2026 governs medical device clinical investigations, reinforcing clinical quality management and risk-based oversight. CluePoints is built to operationalize all of them.
FDA, EMA, MHRA & PMDA Guidance
FDA, EMA, MHRA, and PMDA have all aligned around risk-based, proportionate clinical trial oversight, and that alignment is now mandatory, not aspirational. The FDA and EMA formally adopted ICH E6(R3) in 2025. The MHRA introduced its most significant clinical trial regulatory reforms in two decades in April 2026, embedding ICH E6(R3) and E8(R1) into UK law and introducing a risk-proportionate framework for trial authorization. CluePoints is built to meet all of these expectations in every region where your trials run.
Collaborative Pathways in Clinical Research Communities
CluePoints is committed to collaborating with other clinical research experts across various areas, including improving R&D, enhancing study quality and compliance, setting new industry standards, and advancing data analysis and reporting. CluePoints strives to align with the industry’s future vision and ambitions, which include contributing to the collective expertise and shared goals of the following organizations.
