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)
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, what […]
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 […]
RACT Use in Clinical Trials: How to Implement Risk Assessment Categorization for Better Trial Outcomes
The move toward Risk-Based Quality Management (RBQM) is transforming the landscape of clinical trials by introducing a more efficient, data-driven approach to ensuring trial integrity, participant safety, and regulatory compliance. Inspired by TransCelerate’s Risk Assessment Categorization Tool (RACT), RACT provides a structured approach to identifying, categorizing, and managing potential risks in clinical studies. The RACT […]
From Dialogue to Action: Women at CluePoints on Driving Gender Equality Forward
At the current rate of progress, it will take until 2070 to reach equal representation for women in STEM1 and 2158 to achieve full gender parity.2 These shocking statistics highlight the need to take swift and decisive steps to achieve gender equality. But what do those steps look like, and how can we help speed […]
Meet MSR: Why Data Accuracy Matters in Clinical Trials
Accurate data is the backbone of successful clinical trials. Every piece of patient data, from electronic health records (EHRs) to lab results, holds critical value for decision-making processes, influencing not only trial outcomes but also patient safety. Traditional, manual methods of medical and safety reviews often struggle to keep data fresh, consolidated, and error-free, and […]
The Bold Future of RBQM for CROs
In a world where complacency is the enemy of progress, Contract Research Organizations (CROs) stand at a crossroads. Traditional approaches have their merits, but they’re no match for the transformative power of risk-based quality management (RBQM). It’s time to be bold, challenge the status quo, and redefine the future of CROs. CROs are uniquely positioned […]
