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Why is the funnel plot so important to risk-based monitoring?

Before I dive into some of the detail about funnel plots, I wanted to start by highlighting a few key concepts, driven by risk-based monitoring (RBM) which are likely to come into play, whatever your specific approach to RBM is going to be:   You want to start assessing site quality risk as early in the trial as possible,…

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A monitor’s perspective on RBM

I recently had the pleasure of meeting with a group of monitors and trainers working on a RBM project.  Over the course of the meeting the team were introduced to terms such as risk, mitigation, thresholds, key risk indicators (KRIs), probability, RAG (red, amber, green) status, root cause analysis …  I could see their eyes widening as they were faced…

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Build or Buy RBM Technology?

“We are trying to decide if we will build or buy something for risk-based monitoring”, or some variation of it, is something we hear at nearly every meeting with a prospective customer of TRI’s OPRA. With everything from email to infrastructure to applications frequently being outsourced today, I find it curious that so many companies are interested in making…

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Risk-based monitoring poll #2

Again, we want to say thank you for all those who attended and the very positive feedback we’ve had since the webinar. We asked you where the key challenges in implementing RBM are.  It should be noted that we allowed the respondents pick more than one challenge if they wanted to. The results are shown below: Knowing where to…

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The impact of RBM on sites

1 – There are still a significant proportion of trial sites who are not being informed that there is a risk-based approach being taken to the monitoring of their site. This is an easy issue to remedy and one that will start to build trust immediately. 2 – There is concern from sites that RBM is being used to…

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Risk-based monitoring poll #1

Firstly, I wanted to say thank you to all those people who attended the webinar. It is very gratifying when so many people dial in. We asked you all where you were in your RBM program. The results are shown below: Not yet started – 12% In planning – 12% Developing processes and or selecting technology – 24%  Running…

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The maturing of RBM implementation

  As we at TRI continue to engage with industry on RBM implementation, I am pleased with the observations that we are currently making across a range of CRO and Pharma companies. Rolling back the clock 18-24 months and most of the discussions we were having with customers and prospects were about risk detection, data visualisation and stats models….

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Does Risk-based monitoring improve inspection readiness?

This highlights a serious concern in the gap between what the regulatory authorities are looking for from RBM and the way in which RBM is being practiced. Triumph Research Intelligence (TRI) have engaged both the MHRA and FDA during the design and development of their operational platform for quality oversight and RBM, and during those discussions heard loud and…

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2014 Risk-based Monitoring in Clinical Studies

If you want to find out more about Risk-based Monitoring, the opportunity it presents and the approach TRI are taking to helping companies start their RBM journey then please join us at the CBI event. Triumph’s CEO, Duncan Hall will be presenting to the audience on the following topic:   Operationalizing RBM — Turning Insight into Action into Evidence…

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