ICH E6(R3), Demystified Part 2: Defining Critical-to-Quality
Ethical and Actionable Trial Outcomes ICH E6(R3) is more than just an update to Good Clinical Practice (GCP). It represents a fundamental shift in how the industry defines quality and requires sponsors and CROs to show intelligent oversight focused on what’s Critical-to-Quality (CtQ). E6(R3) specifically calls for prospectively defining CtQ factors and associated risks. In this article, we explore how to identify and document CtQ factors that drive risk management and how to create a CtQ register […]
ICH E6(R3), Demystified: Turning Guidance into Oversight: Part 1
The New Era of Good Clinical Practice: A Practical Guide for Sponsors and CROs The updated ICH E6(R3) guideline represents a cultural shift in how the industry defines and demonstrates quality. No longer a checklist of prescriptive controls, it is a flexible, principle-based framework that expects sponsors and CROs to proactively design quality into the protocol, processes, and oversight strategy, protecting participants, ensuring reliable […]
How to Elevate Medical Coding with Machine Learning & Deep Learning
In most clinical operations today, only 50–60% of medical terms are automatically coded. The rest? Manual review. Multiple passes. Hours of coder time per study. This bottleneck drags down data quality and delays critical downstream analysis. Medical coding sits at the center of clinical trial operations, yet the process has remained largely unchanged for years. […]
What to Expect at RBQMLive 2025: A Glimpse Into the Industry’s Leading RBQM Event
Welcome to the fifth annual RBQMLive—happening one day only on September 25. This free, virtual event brings together leaders from every corner of the clinical research world to explore the trends, technologies, and strategies shaping Risk-Based Quality Management (RBQM). Whether you’ve joined us before or this is your first time, RBQMLive 2025 delivers a bold, […]
Leveraging RBQM In Ways You Never Envisioned
Risk-Based Quality Management (RBQM) is fast becoming a staple in clinical research, and the community is still learning new ways in which the approach can add value to drug development and Sponsor organizations. From monitoring sustainability metrics to enabling proactive inspection readiness, the model—first mandated by the International Council for Harmonization (ICH) in its guideline […]
Risk-Based Study Execution (RBx) – It’s Time To Close The Loop!
Transforming RBQM into Proactive Quality Actions When the journey began, the focus was clear: monitoring. The goal was to eliminate inefficiencies, optimize resource use, reduce costs, and preempt quality issues that could jeopardize clinical trials. This was the genesis of “focus on what really matters,” a principle that brought Risk-Based Monitoring (RBM) to life. RBM […]
Decoding ICH E6(R3): What It Means for Risk-Based Quality Management (RBQM)
https://cluepoints.com/ich-e6-r2-miracle-pill-for-the-clinical-rd-industry/ Authors: Frederic Blais, Jelena Pasimisina, Melissa Thomas ICH E6(R3) provides greater clarity on proactively designing quality into clinical trials, identifying critical-to-quality (CtQ) issues and adopting risk-proportionate approaches. The industry has been encouraged to implement it in the spirit in which it was written, focusing on issues critical to patient safety and trial success. So, […]
10 Steps for Practical RBQM Implementation for Your Business
Many clinical trial Sponsors and Contract Research Organizations (CROs) realize the great benefits of Risk-Based Quality Management (RBQM), and leading regulatory bodies such as the FDA, EMA, and ICH are championing its progressive strategy, including Risk-Based Monitoring (RBM) in clinical trials. RBQM advocates for a shift toward centralized and risk-focused monitoring methods, which aim to […]
QTLs: Where Are We, And How Much Further Can We Go?
Quality Tolerance Limits (QTLs) represent a significant advancement in clinical trial research, aimed at proactively identifying and managing risks that could jeopardize study validity or patient safety. Mandated by the International Council for Harmonization (ICH) in its guideline for Good Clinical Practice, E6(R2), QTLs were introduced in 2016 as part of a broader shift toward […]
Risk-Based Quality Management (RBQM) Adoption: Shifting from “If” to “How” in Clinical Trials
Risk-Based Quality Management (RBQM) solutions allow Sponsors and CROs to confidently detect and effectively manage risk in clinical trials. It’s an evidence-backed approach with regulatory backing, meaning wide-scale adoption is becoming increasingly inevitable. But how do organizations embed this new way of working into their processes? Laura Trotta, VP of Research at CluePoints, says technology […]
