Looking through the lens of a CRA?
In my role as a product leader, it’s always important to stay on top of trends and changes in the industry. One area that has gone through changes in recent times, and will no doubt continue to do so is that of site monitoring.
By now I think that we all know what the changes in ICH E6 R2 say about monitoring, I don’t really need to repeat that here. The bit I find quite interesting though is that because of the regulation changes there is now this drive for RBM and this drive for more centralised monitoring which, yes, I do believe is going to help CRAs - but I think is also detracting away from some of the key pain points that they will continue to experience irrespective of a reduction in on-site monitoring. CRAs are the focal point between sponsors/CROs and the sites and they are forced into working with a number of different systems and processes in order to their job. There is data in all sorts of places that they need to be aware of and use to make informed decisions and centralised monitoring is there to support.
I’m all for change, I’m all for maximising the data that we collect in clinical trials to aid more efficient and more accurate ways of working. However, I am also all for the end user and ensuring that whatever we do to change doesn’t forget them and what it is they are suffering from. CRAs are still going to go on-site, they are still going to perform a lot of the activities that they have traditionally had to and with that they need the right tools, systems and processes in order to make them efficient and more effective. Just saying ‘you’ll do less onsite monitoring and less SDV’ does not mean they will have less work. Just saying that the central monitoring group can provide greater insight into areas of more risk also doesn’t mean they will have less work, or less stress in working across multiple tools and processes.
Our goal at PHARMASEAL is to provide an intuitive user experience which facilitates changing conditions in the industry but doesn’t ever forget about the outcomes our end users are trying to achieve. We recently posted about our Site Monitoring capability and I strongly believe that what we have developed (and will continue to) is serving both the CRA of today in alleviating some of their current pain points as well as the CRA of tomorrow who has access to more data, in real-time and can thus operate either at home, on the move or on-site without having to use 3rd party tools to get their job done.
The role of the CRA is changing. It is evolving. But it is not going away just because of RBM and centralised monitoring therefore it is incumbent on us that support this critical role in a clinical trial to evolve our offerings to support them as their roles change.
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