SCOPE 2024: YPrime CEO, Jim Corrigan Speaks About the Company and Addressing Uncertainty in Clinical Trials

Applied Clinical Trials: Could you tell our audience a bit about YPrime?

Jim Corrigan: First, thanks so much for having time here. It's great to be here at SCOPE again. I get the question a lot about why YPrime? And it's kind of fun to answer. The company is organically built, which is unique in the space; over 17 years, and the founder, Shawn Blackburn still works with us quite intimately in the company, so that's great to see. But when I came to the company, I really felt there was a couple of things that really made a lot of sense. One, I'm still very, very passionate about solving the problems for patients. One of the things that we really focus on at YPrime is that there is patients waiting for the things that we're all trying to do here at SCOPE and within the pharmaceutical business. And that really involves a couple of different constituents: one, pharma, they're the ones developing the drugs, and then two, the sites and the patients with conditions. And they're the ones actively working on these clinical trials, trying to really match the right patient with the right outcome. And so for us at YPrime, we say, well, how can we help there? Our “why” is really focused on simplifying clinical trials so that we can advance science and health for everyone; our family, your family, it doesn't matter. We also have to say, well, where are we going? Well, we're so inspired by the fact that we're going to make the simplification happen. But we really want to make sure that patients and sites feel that. Clinical trials are tough enough, you have someone who's sick and you have someone is trying to help someone who's sick; we do not want to make the clinical trial process any more invasive than it has to be. And so for us, we really focus on that. One of the things that you'll see here in SCOPE is some of the reports that we've done. I've been in the industry now for about 15 years. Whether it's site startup or site adoption of technology, it really all comes down to there are too many delays, too many amendments, and quite clearly too many dropouts. And so for us at YPrime, we say well, how can we help at least manage that better? And speed and quality is the way that we do that. At YPrime, if we have the protocol, if we have the design, if we have the number of languages that the trial is going to be based in, we can get our trials up and ready within weeks. And that is an industry best practice. And that also translates to amendments. So again, as a clinical trial operator is learning about the trial, which is what the whole point of a clinical trial is, they're going to make amendments, we understand that. And our ability to respond to those amendments, and help them solve that problem with a level of certainty is really the YPrime difference. Now, our experience; everyone in clinical trials has experience. The difference at YPrime is that we're incredibly focused on IRT, clinical supplies consulting, and eCOA. And we've done that incredibly purposefully; we built our technology around that, we built our base of expertise in terms of our SMEs around that. And so, when we give the commitment to our customers of solving with certainty, we can help them from the design of the protocol, all the way through the development and implementation, user acceptance testing, go live, but most importantly, through data lock. We really want to make sure that our customers feel the YPrime difference in terms of making it simpler and easier, making it less invasive, making it less complex. But most importantly, getting them to the outcome as quickly as possible. Some people would say, “Let's fail a little bit faster.” We would say, “Let's succeed a little bit faster.” And that for us is the YPrime difference.

ACT: Where do you think uncertainty in clinical trials comes from and how can it be addressed?

Corrigan: A clinical trial is an experiment, it's trying to solve a problem that is out there in the space. And one, do it with higher safety. And then second, do it with higher efficacy. And so, you cannot discount the heroism that goes into taking on something that no one has ever saw before. The part that I want to make sure and that we focus on at YPrime is never forgetting that it always comes down to two people: the patient who is sick, and the clinician who is trying to help that patient feel better, or give them hope, or in some cases, just make them have the opportunity to see what their journey is going to be in terms of recovery. And so by delivering information at the right time, with higher levels of efficacy and higher levels of quality, we feel we can help all three constituents; we can help pharmaceutical companies, we can help the clinicians, and we can help the patients. Again, we're doing it with compliance, we're dealing with safety, we're dealing with quality, but making sure people have the right information at the right time so that they can make sure when they wake up every day and go to sleep every night that they know that they're making progress. That is so important in the clinical trial journey and in everyone's healthcare journey.

ACT: YPrime recently released its eCOA report. Could you tell our audience a bit about the results and challenges it identified?

Corrigan: Recently, we've done a lot of remarketing and rebranding, and we've done that really for one very significant reason. We're very well known in the industry, but we really want to make sure that we have people rethink and ask the question that you just asked me: why YPrime? And so, this report is really a big thing that really helped us. And we've found that over one out of every two clinical trials are delayed for a variety of reasons. Almost 80-90% of them have some type of data quality issues. And then almost 70% of them have some level of changes. And so that within a clinical trial process, which is already trying to solve a problem that's very difficult to begin with, really adds a lot of complexity to that. So we're saying, “How can we make the information flow from the design of the trial, through the implementation and testing and then through the deployment be so much more efficient?” “How do we make sure that we do not add any percentage points to any of those issues, but we actually take down the cycle time so that the data quality can increase so that the number amendments when they do happen, can happen faster?” And so that when a trial has to start up, we don't talk about months; we talk about days and weeks. And that really is something that our customers, which are pharma, really, really are excited about. But most importantly, and I keep coming back to this, that patients on the sites get to see the benefit sooner.

We have one little thing that we just implemented, if you don't mind me talking about it. So we sponsored an innovation network, and it had nothing to do with YPrime. It was just getting industry experts together and talking about the problems in industry: study delays, data quality, etc., and we said, “We're going to come up with different ideas, we're going to brainstorm, and we want to pick the ones that we feel are the ones that are most effective for the industry.” And so someone came up with the Heinz ketchup idea. And if you remember, Heinz ketchup, the bottles used to stand up and now they stand upside down. It was a brilliant idea, correct? Well, we came up with an idea where we said, why don't we put QR codes on the outside of our boxes, so that when they arrive at a clinical site, all they do is click them, and they know it's a YPrime trial, with this protocol and how many devices are inside it; it's all they need to know. Then when they open up that box, and they have the boxes inside with the devices, whether they be tablets or handhelds, doesn't matter. And they click on that, again, they know that device number, they know what trial it's for. And if they want to initiate the device and get it started, they can do it. And then the last box, they open up and they have the device itself, they click on that, the device turns o,n the device knows where it is from a geofence perspective. The device asks, “Would you like some additional training?” Because it's been many, many months since the training actually occurred. And then it says, “Do you need any help?” It’s just one simple idea, using very, very relevant contemporary technology that has really made the sites and the patients have less delays. Because again, I come back to this, you know, you pick up that device, and you have to use it, you have to know how to use it, you have to make sure it has accurate information, and you have to make sure that both the site and the patient can interact using a device so that that information can be translated so that the trial can go through approval as quickly as possible. That's just one of the many cool ideas that we have going on at YPrime and it's one of the things that I think is going to not just help us take these percentages down, but also help address the root causes of these percentages and really prevent them from happening in the future.