Building Critical to Quality Trees helps you to translate critical study needs and quality drivers into measurable outcomes and processes. Initially, this Lean Six Sigma approach serves as a business tool based on customer needs. Still, it is a helpful method of implementing Quality by Design in clinical research.
Do you find the prospect of Risk Analysis and Risk-Based Quality Management (RBQM) to be daunting? Then bear with us. We shall help you simplify and demystify the process by using an example to illustrate the key steps to consider.
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.
