The Right Tool for EDC

By Dr. Kuno van der Post | Chief Commercial Officer, eClinical Division

Recently, I’ve been thinking about the right tool for the job. It has a lot to do with trying to work on my Triumph Bonneville and realizing that I actually need a plethora of different sized tools (that I don’t entirely have) to get the jobs done. Ah well. We all learn. I didn’t think about the unpredictable repairs and replacements that could arise at the time of purchase. I had bought into the brand.

Interestingly, I am having similar (and more interesting) discussions with prospective clients whose studies/trials are in big trouble due to Covid-19. They are trying to find ways to overcome some significant problems, including patients/subjects refusing to go to sites, sites not letting monitors on site, struggling to enroll patients/subjects. They have found themselves on the phone asking what technology we have that could help.

There is, of course, something I can offer, but through my questioning, it is clear that they are frustrated that their key critical technologies like the EDC or CTMS or IxR are not helping out. So, we go through the list.

For example, TrialMaster, our EDC system, can support remote monitoring with autoredaction for forms to be attached to eCRFs (seriously powerful as at the very least it will prepare a monitor better for when they do go on site). It has eConsent. It has direct data entry on any device and in doing so, also has built in ePRO helping our clients deploy decentralized, direct to patient studies. It supports RBM, and so you don’t enforce 100% SDV. When they start to break down on the phone and beat their chests clamoring “Why O Why didn’t I use your technology from the outset” (I’ll admit to using a certain amount of theatrical exaggeration here), I am quick to state that it is not too late. We have done so many rescue studies and database migrations that we can get started immediately and thanks to some smart product development, it has the ability to make really fast mid study changes as you make the big changes to your protocol (great for when you hit problems like this).

So my message to people running their studies, always try to find the best tool for the job. Not all EDCs, CTMS, etc. are alike. In fact, there are big differences. Today, these are differences that are determining the continued conduct of a study vs. putting it on hold. It couldn’t get more impactful! I am seeing great (and highly enviable) marketing being delivered by companies with far deeper pockets than my company and they are selling their wares effectively as you’d expect.

Yet, I know this isn’t easy. It isn’t easy to get into the super fine details of finding the right tool for the job. But, amazingly, I am actually seeing people starting to “re-learn” about all things EDC and what the nuances of functionality can mean in terms of study success vs failure. Truthfully, I am a little humbled. I feel like I should follow their example. Can you believe that I am on my second Triumph Bonneville?  I caught myself just yesterday reviewing details of the new Bonneville T120.

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