HighPoint Blog

Lee Walke, Director, Research and Development

Lee Walke, Director, Research and Development, works with clinical research teams to identify and implement optimal technology and processes. He has 28 years of experience in clinical research, with a focus on data collection, analysis and reporting, and developing and deploying technologies to facilitate these areas of clinical research. He has been a leader in applying technology and common-sense solutions to complex problems in clinical research; including Data Integration, Data Standards, Quality Processes, Real World Evidence, Electronic Trial Master Files, Risk Based Monitoring, Electronic Patient Reported Outcomes, and accessing data from Electronic Health Records. He earned a Master of Science degree in Management Information Systems and a Bachelor of Arts from the University of Virginia.

Recent Posts

In this continuing blog series, we explore the adoption challenges of risk-based monitoring (RBM) of clinical trials. So far, we’ve addressed the risk assessment process and centralized monitoring of analytics. In our latest post, we explore the broader challenges of organizational change that research teams face when moving to RBM.

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The shift to risk-based monitoring (RBM) is not without challenges for clinical research teams. In a previous blog, I outlined three key adoption challenges teams face. That blog also provides an in-depth review of the first challenge, risk assessment. In this blog, we focus on the challenge of establishing and performing the sophisticated statistical analyses which are critical to detecting...

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By now, there is strong consensus that Risk Based Monitoring (RBM) is an essential practice in clinical research. There are ample resources and supporting data on the benefits of a Risk-Based approach to monitoring, and we will not add to the chorus of voices promoting its adoption.

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Recent Posts

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