Clinical monitoring is a critical element of every clinical trial – and it can be one of the most costly aspects of your trial.
Much has been written about the use of risk-based monitoring (RBM) or risk-based quality management (RBQM). Remote monitoring and centralized monitoring have been promoted more recently as part of decentralized trial deployments.
So what are the right elements you should consider for your trial? You have a multitude of options, ranging from outsourcing your monitoring needs with a full-service RBM implementation driven by your CRO or partner of choice, or you could implement your own monitoring platform, integrating your study processes for use across your portfolio, or every aspect in-between.
If you are responsible for delivering clinical trials as a project lead, heading up clinical operations, medical or clinical monitoring, or driving your outsourcing strategy, you should understand the breadth of your choices.
Zabir brings expertise spanning risk-based and centralized monitoring, business analysis, continuous process improvement, and analytics for clinical trials. He is currently a process lead for Centralized Monitoring, including advanced analytics, for clinical trial design and execution. He holds a Bachelor’s degree in Computer Science from India and has a MBA in Management and Marketing from USA.
Gayle is an experienced Risk-Based Monitoring project advisor and project lead with an extensive background in clinical operations and project management. She has supported RBM Thought Leadership, IT development of an end to end Risk-Based Quality Management system, and study teams in RBM implementation across all phases and therapeutic areas, driving the development of processes, tools and systems assuring high quality business performance of clinical operations within global projects. Gayle’s background is in emergency medicine and nursing.
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