Best Case Studies for RBQM | Avoiding Regulatory Non-Acceptance
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.
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.
We can help establish near real-time centralized monitoring, enable the use of "ad-hoc crisis management" Key Risk Indicators (KRIs), and mitigate patient safety and study quality risks.
Adaptive and intelligent Risk Based Quality Management (RBQM) is a powerful strategy for rare disease research. One of the main benefits is that RBQM allows for patient-centric trial design that is uniquely tailored to the specific rare disease.
As change can be a significant source of risk, RBQM or risk-based monitoring (RBM) implementation programs should include a roadmap and change management plan for initiating a process of continuous improvement.