3 Protocol Considerations that Drive eCOA Design

August 23, 2017


Full Transcript

So there are various key parts of the protocol that we’re gonna really pay a lot of attention to because they have a lot of influence into what we’re gonna design. So the very first thing is, what are the end points. What is this study, this trial, trying to collect.

So primary and secondary and then the tertiary or exploratory endpoints, they’re in the order of priority. And that gives a message to us, what is the most important piece of information that this trial is trying to collect, and that’s the parts then that we have to pay particular attention to.

But there are other parts of the protocol that we’re gonna pay a lot of attention to. So for instance, you’ve got the inclusion-exclusion criteria. And some of those criteria are gonna be related to the data that we may end up collecting. And so what we can do is, we can take the data we collect, run it through the calculations, and then tell the sponsor or the site, whether the subject meets that particular inclusion or exclusion criteria. It’s really helpful for them.

We’re going to pay attention to the schedule of assessments, so that’s where everything is listed out as to what’s being done, and make sure we haven’t missed anything, because some of the pieces of data that we may end up collecting aren’t actually part of the endpoints

So what’s the data, when is it collected, what type of calculations might we be doing. All of those things are things that are in a protocol that are gonna influence the design of the solution.

And what we need to do is take all this information from the protocol and put it together and say okay, what would we really recommend here.

But we’re also kind of taking a step back and thinking, what is the best solution for this. Okay. This is what they want to collect, this is how they’re thinking about running the study. What is the right modality. And we have various modalities. Now, in our solutions, we have hand-held devices, we have tablets, we have an app, we have ah web-based types of modalities.

And so we’re gonna make sure we pay particular attention to that so that we collect that with the highest data quality possible.



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