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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Identifying re-enrolled subjects in clinical trials, the sequel

This past June, at the Drug Information Association (DIA) annual meeting, I had the opportunity to present and participate in a panel discussion on innovative approaches to ensure quality and compliance in clinical trials. Not surprisingly, a majority of the discussion focused on sponsor responsibilities for building quality into its […]

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New JMP book on risk-based monitoring & fraud detection in clinical trials

Risk-based monitoring (RBM) is a hot topic in the clinical trials arena. It’s a new way of designing and operating clinical trials. Now, rather than visiting each clinical trial site and reviewing all patient records, you identify just those who present the higher risk of poor data quality, fraud and […]

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Coming in July: Book on centralized monitoring of clinical trials

In the spirit of shameless self-promotion full disclosure with the goal of collecting huge royalty checks promoting the efficient review of clinical trials, I’d like to make everyone aware of the forthcoming SAS Press title Risk-Based Monitoring and Fraud Detection in Clinical Trials Using JMP and SAS. Clinical trials are […]

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More things to love about JMP Clinical 5.0: Internationalization 更多的值得您挚爱的JMP临床5.0:国际化

Richard Zink blogged about “7 things to love about JMP Clinical 5.0” the day that JMP Clinical 5.0 and JMP Genomics 7.0 were released. In his post, he highlighted seven important new or improved functions in JMP Clinical 5.0, including RBM (risk-based monitoring), fraud detection, SMQs (Standardised MedDRA Queries), predictive […]

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Summarizing patient safety with standardized MedDRA queries (SMQs)

If you work or have worked within the pharmaceutical industry, then you are likely familiar with MedDRA, the Medical Dictionary for Regulatory Activities. This dictionary makes it possible for drug and device companies to perform analyses of adverse events or medical history. First, MedDRA provides a way to consistently map […]

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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: Visualizing the risk to your clinical trials

We’ve talked about the data. We’ve defined our thresholds for risk. Now it’s time to talk about how you can visualize the safety and quality signals from your ongoing clinical trials. If you want to minimize the impact of quality issues to the data or quickly address any safety concerns […]

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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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