HighPoint Blog

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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Let’s face it – traditional on-site monitoring is becoming obsolete. Given the complexity of today’s global, multi-site clinical trials landscape, traditional site monitoring can be an inefficient method to ensure patient safety.

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