Achieving Success in a Phase 3 Dermatology Study with the Power of Effective RBQM
In clinical research, ensuring data integrity and patient safety is paramount to the success of any study. Risk-Based Quality Management (RBQM) focuses on addressing and resolving significant errors that could impact these critical areas, rather than striving for an unrealistic zero-error objective. By prioritizing the identification and mitigation of major risks, RBQM enhances the overall quality and reliability of clinical trials.
Download this case study to learn how CluePoints’ advanced statistical methods and centralized monitoring techniques led to the early detection of potential issues, maintaining the highest standards of data quality and participant safety.
This case study explores how RBQM was used to protect data quality in a Phase 3 dermatology trial, revealing and correcting issues that threatened the study’s success. Discover how CluePoints helped a renowned dermatology company and their CRO partners identify and manage risks, ensuring reliable and efficient trial conduct across 24+ sites with 680 participants.
About CluePoints
CluePoints is the premier provider of RBQM and data quality oversight software. We’re leveraging the potential of artificial intelligence using advanced statistics and machine learning to determine the quality, accuracy, and integrity of clinical trial data both during and after the study.
Aligned with guidance from the FDA, EMA, ICH, and MHRA, CluePoints supports central and on-site monitoring, medical review, and quality risk management to drive a holistic risk-based strategy in all trials. Coupled with thought leadership and consulting expertise to aid pre-study risk assessment, identification of risk controls, and solution implementation, you now have everything you need to adhere to global regulatory guidance. The result is positive clinical development outcomes, increased operational efficiency, lower costs, and reduced regulatory submission risk as part of the industry paradigm shift to RBQM.
