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.
Nov 2020
Nov 2020
Best Case Studies for RBQM | Controlling the Number of Open Queries
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.
Nov 2020
Best Case Studies for RBQM | Accurately Predicting Important Events
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.
Nov 2020
Best Case Studies for RBQM | Detecting and Mitigating a Conflict of Interest
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.
Sep 2020
FDA Concerned About Statistical Power COVID-19 Impacted Clinical Studies
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.
Aug 2020
Optimization of eCOA Data Quality using Risk-Based Quality Management
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.
Apr 2020
Q&A | Minds-On Impact COVID-19 on Clinical Trials
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.
Mar 2020
Coronavirus | What if you can no longer visit your sites?
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.
Feb 2020
Indication Focused RBQM for Rare Disease Drug Development
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.
Feb 2020
Change as a Risk?
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.