In Alignment with All Major Regulatory Bodies
Our central statistical monitoring technology adheres to GCP guidelines set by regulatory bodies such as the FDA, EMA, MHRA, and PMDA, ensuring users can meet modern standards of compliance and efficiency. Discover how our expertise seamlessly integrates with the latest regulatory directives.
Food & Drug Administration (FDA) Guidance
The FDA’s risk-based monitoring guidance supports a more targeted, data-driven approach to clinical trial oversight. Its guidance emphasizes study risk assessments, centralized monitoring, documentation of monitoring activities, and reduced reliance on traditional onsite monitoring and 100% source data verification (SDV). It also highlights the value of statistical analysis of clinical data to identify potential risks, trends, and quality issues. These principles are highly relevant to CluePoints clients using RBQM and centralized monitoring to improve trial oversight, patient safety, and data quality.
Guidance for Industry Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring
A Risk-Based Approach to Monitoring of Clinical Investigations: Questions & Answers
European Medicines Agency (EMA) Guidance
EMA guidance supports risk-based approaches to clinical trial quality management, including early risk assessment, ongoing risk review, centralized oversight, and the use of Quality Tolerance Limits (QTLs) to help manage risks to critical trial processes and data. These expectations align with the modern Good Clinical Practice principles reflected in ICH E6(R3), which emphasizes proactive quality management, risk-proportionate approaches, and fit-for-purpose trial oversight.
Medicines & Healthcare Products Regulatory Agency (MHRA) Guidance
The MHRA released guidelines emphasizing tailored approaches to clinical trials and oversight of investigational medical products, stressing the benefits of risk-adapted strategies, such as cost reduction and improved resource use. The risk-adapted approach to clinical trials categorizes trials by associated risks and mandates specific assessments to inform management and monitoring strategies. The companion oversight and monitoring guidance outlines strategies aligned with trial risks, including central monitoring and statistical techniques. It also recommends a risk-based approach to source data verification to prioritize verification based on trial risk levels.
Good Clinical Practice for Clinical Trials
Oversight & Monitoring of Investigational Medical Product Trials
Pharmaceuticals & Medical Devices Agency (PMDA) Guidance
PMDA and Japan’s Ministry of Health, Labour & Welfare (MHLW) support risk-based approaches to clinical trial oversight, including risk-based monitoring and source data verification (SDV). PMDA materials emphasize the use of monitoring approaches tailored to trial-specific risks, with attention to critical processes, data quality, patient safety, and inspection readiness. PMDA also conducts GCP compliance assessments to confirm that clinical trials are conducted ethically and scientifically, in compliance with GCP, and that submitted data meet regulatory expectations for integrity and reliability. These priorities are closely aligned with CluePoints clients’ use of RBQM and centralized monitoring to support more focused, data-driven study execution.
