PAREXEL - Drew Garty Discusses the Differences in Monitoring Types and new Innovations
The real difference between Risk Based Monitoring and Data-Driven Monitoring is that Data-Driven Monitoring incorporates Risk Based Monitoring as one of the key elements into monitoring. Ultimately, monitors need to focus on a wide variety of inputs, risk or quality related issues, also the workload, and the activities that need to be performed to validate quality. In addition there’s a relationship. It’s important to remember that while a single undetection of a quality issue is good, the key of the monitor is actually the ability to influence that and motivate the site to improve either in their quality or performance. Some examples of innovations around Data-Driven Monitoring include adaptive monitoring where we’re really deploying now resources in a truly agile manner. Another is the combination of coupling of the cost of quality, not only looking to quality as an end goal but the effectiveness to which we reach that, and understanding that cost of quality helps to drive our cost down, and allow us to put more resources to improving quality yet again. PAREXEL has developed a number of innovative tools to support Risk Based and Data-Driven Monitoring. Namely, Data-Driven Monitoring itself, which is a tool utilized by monitors, the CRAs, (onsite as well as remote monitors), focused on also the line managers to understand the monitoring resource allocations, global resource management and clinical leads. In addition, while we’re focused predominantly with Data-Driven Monitoring and operational data, we also focus on scientific data and its interrogation through the data surveillance solution. Data surveillance allows for a cross-functional review of the scientific data, ensuring the highest degrees of patient safety and study integrity.