The Value Of Risk-Based Management (RBQM) in Clinical Trials
Risk-Based Quality Management (RBQM) has been increasingly integrated into clinical trial practices by the FDA and EMA since 2011, becoming a GCP expectation in 2016, with further reinforcements in subsequent years. The shift is driven by rising complexity and costs in clinical research, evidenced by a significant increase in procedures, participating countries, and endpoints per study. Contact us to discover how we can support your upcoming clinical trial or to request a demo of our platform.
The Journey to RBQM in Clinical Trials with Vertex, Astellas & Parexel
Why Risk-Based Quality Management Software from CluePoints?
As RBQM innovators, we harness advanced statistics and machine learning, leveraging RBM software solutions to turn data into positive clinical outcomes.
Analytics & Risk Detection
Analyze data, detect patterns, and derive insights that drive proactivity and compliance. Our RBM software ensures effective risk and data management, as well as the optimization of clinical trial processes.
Trial Management & Documentation
Document issues and actions taken in RBM clinical trials to manage risks effectively and ensure compliance. Our RBM software fosters transparency and facilitates the knowledge transfer of all crucial analytics and risk management processes.
Expertise & Client-Focused Services
Leverage experienced RBM and clinical research data analysts and specialists. CluePoints targets areas requiring attention and manages implementation, streamlining workflows and establishing a robust foundation for compliance efforts.
RBQM Adoption
Revealed
What’s shaping today’s RBQM landscape? Discover the answers in this insightful webinar from the Tufts CSDD, CluePoints, and PwC. Explore survey findings from 206 responses spanning 32 RBQM practices, revealing trends and actionable insights for pharmaceutical, biotech, and CRO organizations.
The Ultimate Guide
to Risk-Based Quality Management (RBQM)
Every organization’s RBQM journey is unique, but the core principles remain universal. This guide provides expert insights, proven best practices, and a clear step-by-step framework for confidently rolling out RBQM. Overcome challenges like organization size and therapeutic focus and unlock the keys to success.
Quantifying the Impact of RBQM Central Statistical Monitoring: Insights from 159 Trials
Can central monitoring transform data quality? See the impact in this analysis of 1,000+ sites across 150+ trials. From uncovering risks to enhancing patient safety, the insights reveal how central monitoring changes the game for clinical research.
Understanding New Sources of Risk in Decentralized Trials
Decentralized trials aren’t going anywhere. Understand new risks related to end-user error or misuse and flawed technology.
Driving Smarter Trials with CluePoints
CluePoints is the premier provider of RBQM and data quality oversight software. Powered by advanced AI, including machine learning and robust statistical methods, our platform ensures the quality, accuracy, and integrity of clinical trial data throughout and beyond the study lifecycle. Fully aligned with industry guidelines, we support monitoring, medical review, and quality risk management for a comprehensive risk-based approach.
