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A great Sponsor question

Last week I was asked a great question by a Sponsor. “What does RBQM Technology give me that I don’t already get for ‘free’ from my EDC, CTMS and other systems?”. A quick demo of OPRA later and not only did they know the answer to the question, but they now want to use OPRA on all their clinical trials.

So, what does RBQM Technology give you that your existing systems don’t? Very simply, it creates a framework for quality, and then provides views and insights to manage quality which you can never get from a single source system.

It sets you up for success by giving you a simple, structured approach to identifying and evaluating risks and factors critical to success, as well as being able to review historic data to understand what has worked well in the past (a key component of quality by design as set out in ICH E8(R1)).

Once your trial is up and running, aggregating data across multiple sources gives you visibility into what’s going on across your studies in a way you can’t achieve with point solutions.

For example, how do I simply identify what data is missing at a subject and site level? This view is a combination of forecasting data from the schedule of assessments (usually held in a CTMS) and the actual data being collected by an EDC. Once I have both these data I can compare one to the other and give a clear view of what is missing. This can save you hundreds of monitoring hours and also show emerging trends for sites or cohorts with a propensity for missed data.

Another example is being able to look at historic views of data as they were at the time they were being collected. With an EDC or business intelligence tool, you can only look at the data as it exists at the very moment in time you are assessing it. But what if you want to look at the data as it was months ago and across all source systems to understand why a key decision was made? What if you want to look at quality and performance over time to see if your quality management is being effective or not?

These are key questions to ask of data to know you are being effective and to learn from the data, ready for your next trial (again, quality by design being a driver). These are just a few examples of the way in which RBQM technology, like our OPRA platform, has taken the world of multiple source systems and created one source of quality planning and quality management with visibility and insights never seen before.

At the end of the demo last week the Sponsor said that they’d never heard of RBQM Technology before, but now they’d seen what it can do, they want it for all their trials. If you want to know what it can do for you, let us know and we’ll be happy to show you.


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