Tag: Risk-Based Monitoring

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Helping clinical trials run better, faster

As you read this post over your afternoon coffee, scientists all over the world are hard at work trying to prevent the spread of deadly viruses, and cure and treat debilitating illnesses like cancer, HIV and Alzheimer’s. When a breakthrough happens and one of those scientists puts her finger on

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Getting started with risk-based monitoring

Our own Richard Zink has written extensively about the risk-based monitoring (RBM) capabilities in JMP Clinical, both on this blog and, of course, in his book. As a complement to the wealth of hands-on information that Richard has created, which primarily covers the mechanics of RBM with JMP software, we

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7 things to love about JMP Clinical 5.0

New versions of JMP Clinical and Genomics are available starting today, so I wanted to take the opportunity to give a brief overview of some of the new features you’ll come to enjoy with the new release of JMP Clinical 5.0. Below are seven things to love! 1. Risk-Based Monitoring

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Risk-based monitoring: Defining thresholds for risk

Now that we have put together a data set containing the important metrics to monitor safety and site performance, we need to define the thresholds that constitute elevated risk. Unfortunately, there is no one-size-fits all solution to this problem. The study population (e.g., pediatric, elderly or at particular risk of safety

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Risk-based monitoring: Let's start with the data

To begin our discussions on risk-based monitoring (RBM), we first need to start with the data. The data include various metrics to assess site performance, and may include several key measures of safety such as deaths and adverse events (to assess safety concerns or under-reporting). But where to start? These

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JMP attends the PSI Conference in Edinburgh

I had the pleasure of interviewing Richard Zink, Principal Research Statistician Developer in the JMP Life Sciences division, prior to his visit to the UK to speak at the PSI (Statisticians in the Pharmaceutical Industry) Conference in Glasgow on 14 May. His PSI talk is titled "Assessing the Similarity of