Within the bounds of risk-based quality management, the utilization of predefined Quality Tolerance Limits (QTLs) is a way to control quality and risk in clinical trials. QTLs identify systematic risks to patients and data integrity at the study level. We've listed the 7 most commonly used QTLs that are applicable to most trials.
Learn how risk-based quality management (RBQM) helps simplify coronavirus vaccine development and helps mitigate any unnecessary burden from clinical organizations ensuring vaccines are readily available when needed.
Are you an orphan expert? Do you care about rare? We invite you to collaborate with us on a rare disease-focused RACT that will help reveal and address orphan drug trial risks more efficiently.
We've documented real-life case studies for you, illustrating how the MyRBQM® Portal helped address common risks using the principles of risk-based quality management.
We've documented real-life case studies for you, illustrating how the MyRBQM® Portal helped address common risks using the principles of risk-based quality management.
We've documented real-life case studies for you, illustrating how the MyRBQM® Portal helped address common risks using the principles of risk-based quality management.
We've documented real-life case studies for you, illustrating how the MyRBQM® Portal helped address common risks using the principles of risk-based quality management.
Checking and maintaining trial integrity, and proactively adjusting trial analysis strategies to ensure trial data validity, are the FDA's two key areas of concern.
It took a pandemic to eventually shift the focus to long-overdue regulatory changes. In this article, we explore the concept of risk-based eCOA and how it has evolved over time to befit this ‘new normal’ phase.
We've created this "ask the experts" Q&A to provide clear responses to the questions that were most often asked by the forum's participants.
