Download our DIA 2025 posters and see how upfront RBQM—applied to rare-disease trials and joint CRF design—sharpens data quality, elevates patient safety, and keeps studies ICH E6(R3)-ready.
The COVID-19 pandemic has accelerated alternative distribution strategy adoption to facilitate “new normal” decentralized and hybrid trial concepts. Capturing the IMP supply chain risks associated with these more flexible distribution approaches requires synergy among people, processes, and technology. Former Senior Project Manager at GKM, Anke Mueller, shares with you how pandemic-induced supply chain risk data knitted together in a single RAC tool enabled her study team to pivot quickly and continue their studies in a timely fashion.
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.
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.
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.
