The QbD Column: Is QbD applicable for developing analytic methods?

Development of measurement or analytic methods parallels the development of drug products. Understanding of the process monitoring and control requirements drives the performance criteria for analytical methods, including the process critical quality attributes (CQAs) and specification limits. Uncovering the characteristics of a drug substance that require control to ensure safety […]

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 […]

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 […]

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 […]

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 […]

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 […]

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 […]

Work smarter, not harder in clinical trials: risk-based monitoring (RBM)

There is a lot of interest in risk-based monitoring (RBM) of clinical trials, and it’s easy to understand why. Monitoring activities can account for 25-30% of the cost of a clinical trial, so any efficiencies to be gained can come at substantial savings for the trial sponsor. ICH Guideline E6 […]

It’s time to "crossover" to JMP Clinical 4.1

My colleagues are often surprised to hear I went through five majors in college to find my niche in statistics. I started as a physical therapy major, which quickly turned to nuclear medicine, communications, psychology, and finally late in my junior year I became enamored with the beauty of statistics […]

Got Help? You do in JMP Clinical and JMP Genomics

In a recent blog post, I listed all of the updates to the Help system for JMP Clinical 4.1 and JMP Genomics 6.1. The Documentation team has worked hard to put all of the information you need to do your analyses right at your fingertips. Just click on the Process […]