This article explains why sponsors should adopt RBQM principles early in trial planning, supported by regulatory recommendations, and highlights the benefits of early implementation compared to addressing these elements later in the monitoring plan—or not at all.
Dive into the FDA's latest draft guidance on Decentralized Clinical Trials and the role of Risk-Based Quality Management. Learn how RBQM and centralized monitoring can elevate your clinical research efficiency and reliability.
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.
Predictive Analytics is seen as the next generation methodology: “growing across most therapy areas in the coming years”. Pharma companies and CROs that embrace next generation analytics will position themselves for immeasurable competitive edge in the industry.
Regulatory bodies are unanimous, today's clinical research needs Centralized Monitoring. We summarized Centralized Monitoring the infographic way, download your free copy here...
Our expert team reviewed the March 2019 RBM Q&A draft guidance document and extended the FDA guidance with RBM solution specific insights and a MindMap to help you even further.
Conference season has started! Our first stop was the Global RBM Summit 2018 in London. Our CSO Dr Johann Proeve was invited to join the conversation as a speaker on the topic “Pragmatic Centralized Monitoring – How to get there?”. Johann shares his observations with us.
