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.
Mar 2020
Best Case Studies for RBQM | Merz Pharma’s RBQM Journey
This week Applied Clinical Trials published an interesting case study of the risk-based quality management learning curve. The provision of a set of training modules helped Merz Pharma to initiate a smooth RBQM rollout.
Mar 2018
Adaptive Monitoring: Anticipating The Human Factor
An effective way to control risks during a clinical trial is to anticipate events induced by human factor before the study even begins. Dr Johann Proeve's third chapter on Adaptive Monitoring talks about how human factor is complementary to numeric data.
Mar 2018
Adaptive Monitoring: Beyond Data Trends and Timely Performance
Adaptive Monitoring is not a “status quo”, it is a dynamic response to clinical research that drives monitoring scope and activities to the evolving areas of greatest need which have the most potential to positively impact. Each clinical study requires its own tailored monitoring approach ensuring risks are minimized.
Feb 2018
Adaptive Monitoring: The First Implementation Steps in Real-Life
It is widely broadcasted that pharma companies will have to accelerate adoption of adaptive clinical trial designs to reduce study timelines and costs while increasing success rates. Risk-based Monitoring “Real RBM” integrates the Adaptive Monitoring (AM) process, which addresses all aspects of Quality Risk Management.
Dec 2015
Clinical Trials: Viva Bias
by Alexandra Grossman Alexander K. is a thoughtful man, mid-50s, a writer by profession. He earns money with German and English lessons, and it is almost always tight. "A few years ago, I was sitting in the subway and saw posters seeking volunteers for [...]
Mar 2015
Using RbM to Evaluate Site Engagement
Case Study Clinical trial site engagement has been advocated as a critical component relating to a study’s performance and success, however, a minimum amount of data supports this connection. In this article a reader will find quantitative and qualitative approach based on risk-based [...]