The Ultimate Guide to Risk-Based Quality Management (RBQM)
Every organization faces unique challenges when it comes to implementing Risk-Based Quality Management (RBQM). There are numerous influencing factors, such as organization size and structure, therapeutic focus, and so on. At the same time, RBQM represents a set of universally applicable fundamental principles.
Download our guide to understand these principles and get your hands on an implementation framework and proven best practices to ensure the successful rollout and adoption of RBQM.
What’s Inside
- An insider’s perspective on RBQM’s history and purpose
- Essential insights and strategies for implementation
- Proven best practices for more complicated applications
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.
