ICH E6(R3), Demystified Part 4: Informed Consent
From Signature to System: Why E6(R3) Raises the Bar For years, informed consent has too often been treated as a regulatory artifact, a document to be signed, filed, and archived. ICH E6(R3) quietly but decisively challenges that mindset. The revision does not radically rewrite the rules of informed consent. Instead, it does something more powerful: it […]
RBQM for the Mid-Market Explained
Mid-market sponsors are expected to meet the same ICH E6(R3) standards as large pharma, often with lean teams, heavy CRO reliance, and limited analytics support. The good news: modern RBQM doesn’t have to be complex or disruptive. The Mid-Market Reality Under ICH E6(R3) ICH E6(R3) has clarified something many mid-market organizations already feel: RBQM is no longer optional. Sponsors are expected to demonstrate proactive, CtQ-driven […]
5 Myths Mid-Market Teams Believe About RBQM and What ICH E6(R3) Actually Requires
Risk-Based Quality Management (RBQM) is no longer a future-state concept. Under ICH E6(R3), it is a clear regulatory expectation. Yet many mid-market sponsors still struggle to move from understanding RBQM to operationalizing it. The hesitation isn’t usually philosophical, it’s practical. Long-standing assumptions make RBQM feel complex, disruptive, or unrealistic for lean, CRO-dependent teams. The problem is that many of those assumptions are based on myths, not […]
Modern RBQM Has Evolved. Is Your Organization Ready?
Most sponsors and CROs are now fluent in the language of Risk-Based Quality Management (RBQM). Terms like Quality by Design, Critical-to-Quality factors (CtQs), KRIs, QTLs, and centralized monitoring are widely understood. And yet, many organizations still feel unprepared. Not because they don’t understand the guidance, but because RBQM has evolved faster than the way trials […]
ICH E6(R3), Demystified Part 3: Quality Tolerance Limits
Proactively Identifying and Managing Risks Quality Tolerance Limits (QTLs) were mandated in ICH E6(R2). Reflecting industry feedback, E6(R3) acknowledged QTLs as a tool to support the control of risks to Critical-to-Quality (CtQ) factors. In this article, we explore how QTLs support risk management and how to turn acceptable ranges into actionable triggers. It is the […]
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 […]
