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 […]
Meet SPOT: Transforming Site Monitoring Practices with Adaptive Intelligence
Clinical trial site monitoring is one of the most expensive components of clinical trials; on-site clinical research monitoring alone accounts for around 25 to 30% of the total trial expenses.1 A substantial portion of the clinical trial timeline involves inefficient Source Data Verification (SDV) and Source Data Review (SDR) activities, which can also consume a […]
A New Era of Automation: Improving Efficiency & Outcomes with Intelligent Medical Coding
A New Era of Automation In clinical trials, patient data such as adverse events and concomitant medications must be coded against standardized medical dictionaries like MedDRA and WHODrug. This process, known as medical coding in clinical trials, ensures that data is categorized consistently across sites and studies, enabling accurate analysis, regulatory submission, and cross-trial comparisons. […]
Centralized Monitoring in Clinical Trials: Everything You Should Know
What Is Centralized Monitoring? Centralized monitoring is a key component of Risk-Based Quality Management (RBQM) that enables proactive detection of quality-related risks, both pre-identified and unanticipated, during clinical trials. Central Statistical Monitoring (CSM) is a subset of central monitoring that specifically uses advanced statistical and analytical methods to identify unusual patterns in the trial data. […]
Centralized Monitoring In Clinical Trials: Everything You Should Know
What Is Centralized Monitoring? Centralized monitoring is a component of risk-based quality management (RBQM) that aims to detect emerging quality-related risks (either pre-identified or unanticipated risks) proactively during the conduct of a clinical trial. There are three main elements of centralized monitoring: Statistical Data Monitoring (SDM) serves as an unsupervised method for quality oversight in […]
