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
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
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
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
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,
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
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
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
Meet SPOT: Transforming Site Monitoring Practices with Adaptive Intelligence
Site monitoring is one of the most expensive components of clinical trials; on-site monitoring alone accounts for around 25 to 30% of the total trial
A New Era of Automation: Improving Efficiency & Outcomes with Intelligent Medical Coding
In clinical trials, patient data such as adverse events and concomitant medications is coded against standard medical dictionaries. However, this process comes with challenges. A
