In healthcare, data is essential for development and innovation.
In this episode of Bite the Orange, we feature Niki Kutac, the Senior Vice President of Product Management at Fountayn (formerly Datatrak International), who discusses the relationship between Electrodic Data Capture and clinical trials, and what that conveys for getting drugs to market. Each data entry within a trial determines a different aspect of the drug and information regarding the patient, like the cadence of visits. Fountayn provides technology that makes data capture and management much easier, gathering everything on a single platform that provides insights and improves the clinical trial experience for patients and providers.
Tune in to this short and sweet episode about data management!
FULL EPISODE
BTO_Niki Kutac: Audio automatically transcribed by Sonix
BTO_Niki Kutac: this mp3 audio file was automatically transcribed by Sonix with the best speech-to-text algorithms. This transcript may contain errors.
Emmanuel Fombu:
Welcome to Bite the Orange. Through our conversations, we create a roadmap for the future of health with the most impactful leaders in the space. This is your host, Dr. Manny Fombu. Let's make the future of healthcare a reality together.
Emmanuel Fombu:
Good morning. Good afternoon. Good evening, ladies and gentlemen. Welcome to another episode of Bite the Orange. And today we have a very special guest with a very interesting background. She has been with this particular company for a very long time and has lots of fantastic insights. And today in the studio actually have Jess with me for the first time watching the podcast in real time, I'll introduce you guys to them later. And so today is a very special episode. First time I'm recording with guests actually watching this. So Niki, you're in very special company today. So with that being said, I know kind of leaked the name earlier, but today we'll meet someone that comes all the way from Texas, which is a very unique and interesting hub for technology and innovation that people don't usually talk about, right? Because everyone focuses on talking about California, Boston, New York, but Texas is representing today. And so for those that don't know, the company has a new brand name, it's called Fountayn. They call it Fountain, which is completely wrong. So Fountayn was corrected. And so today we have Niki Kutak joining us. Welcome to the show, Niki.
Niki Kutac:
Thank you. Looking forward to it.
Emmanuel Fombu:
Thank you. That's probably the longest intro I ever did, and I'll probably tell you that, right? But I think it's very special. This is a company that I've spent some time with, know your CEO pretty well, right? And I really care about the company, great people within the company. So I'm particularly interested to actually learn about Fountayn. So tell us, first of all, about who are you, Niki? What's your background? How did you end up in this story and what drives you?
Niki Kutac:
Yeah, so I have been in the e-clinical technology for almost 20 years and I have an interesting background. I actually started as a student worker for a technology doing Double ...
Emmanuel Fombu:
Where were you born? ... Niki ... Tell us about you.
Niki Kutac:
Where was I born? I was born in a small town in Texas called Kern, Texas, about an hour south of Dallas. And I went to college in Texas A&M in College Station. From there, I started working for a company that did a clinical early date, double data entry for clinical trials, and those that don't know what double data entry before you had EDC companies would complete a casebook report on paper.
Emmanuel Fombu:
You know, interesting. I've been in this space of clinical trials now. It's very interesting, like, things like ... for example, right? ... And all these terms, they're pretty interesting cases that you hear about. But look at different clinical trials. Some listeners might actually know how this fits in, okay? So if you describe in general what a clinical trial looks like, what is that problem and what are you solving? Right. I think I'll be pretty interesting because myself, I'll tell you, I'm not an expert on the term .... I'm actually want to learn.
Niki Kutac:
Okay, so the clinical trial is the testing they do to get drugs through the market. It's a fascinating process that take many years and many different trials. He tried endured the right. dosing, the right safety for a drug before it goes through the market. And so from a technology standpoint, I like, EDC is what captures that data during the trial that can then be reviewed and submitted to the FDA. It's kind of like the collection and that's what it's called electronic data capture or the collection of that information that the sites and the doctors are capturing from their patient subjects that participate in the trial.
Emmanuel Fombu:
And this explains piece of clinical trials. So I spent a lot of time as a physician on the front end of trials, designing the protocols and the, design patient visits and other data sets that you use to capture. Then I go to my clinical operations team and I passage over to them, and then they find like a CRO or someone that is able to execute this, right? And it's a whole process of identifying sites and also collecting that data most people don't get to see. Is a very interesting part, and it's like a back end, right, as a developer, it's like a back end developer kind of mindset, right? And it's a very interesting world where a lot of people that necessarily are not clinicians that are doing a lot to actually impact the life of patients because the, the data that you collect is very important, right? Because we have to look at data from a statistical point of view to show that this drug works or it doesn't, so it's very important work. So tell us how this works in the back end. So how you design the study, the CRO study is ready, you have the site, patients are enrolled. Now the patient is on a platform. So what do you do? Is it like an app? Where is the data go?
Niki Kutac:
Yeah. So you take that protocol to the study that you design. Every study is different because you're trying to test different endpoints, you're trying to find different safety mechanisms, that, how the drug works. So you take that protocol or that trial that you designed and you evaluate and determine what is the data that you need to capture to help prove that endpoint, to help determine to execute that trial, to get the data for analysis. So teams take that schedule, like, within the protocol, there's a schedule of events that kind of determined what are the assessments the sites are doing, what is the timeline that those patients are coming to follow up visit, how many visits they're going to have, how many dosing that they take. And we, with our technology, you create casebooks or forms online that the data can be entered into as that patient is going through the clinical trial. So as their assets by, getting their lab work done, as they're at the site, what are their vital signs? What's their medical history? So you can help have that information as that patient progresses, taking that drug or using that device. Our technology helps capture that information, but there's also a lot that goes, it's not just capturing it, you also have to data clean it. So with technology, you can apply, edit checks as they're entering the data, you can provide reports to help schedule out the patient. So when a patient start that screening to ensure that it meets the visit schedule that you define, alerting either your safety teams or even the doctor, if something's entered that's a concern what, maybe an adverse reaction that the patient had had that is tied to the drug or is it related to what's happening or is it just an event that has occurred? So there's a lot that goes on to get the data, but also ensure that the data is accurate and that the patient is safe through it, and you use technology.
Emmanuel Fombu:
Let me interrupt you there. But that's something that's very important, right? As a medical director on several studies, the data you capture, I get an alert, if someone gets like an adverse event, which means that study could stop immediately of we find out that patients are getting sicker or there's something really bad happening, it could be stopped. It's very important the data sets that you're capturing, and it's very important that also get that in real time, right? As someone was seeing that particular study. And so something that is being watched diligently. But with that being said, so Fountayn previously you and others did a track and you've been around for some time. And I've heard about many companies, for example, like if you guys were a CRO, like a massive CRO, right? And I don't need to call any names here or if you look at every sponsor, some life science companies want to run their own studies, right? Which is pretty difficult. So the technology that you're talking about is very unique. Is this something that's easy to develop in the backend? Why not just put it in Excel for example? Right? Why not just documented in the EHR system? What is unique about your technology?
Niki Kutac:
Well, what's unique is what needed, is every trial is different. It's not that you can just go create a study and capture all have a vital plan form or a schedule of events. Every trial that, as you talked about, starting as what the trial is going to do and what is, what's the point of, point of it. The technology has to be configurable and flexible to capture that but it's so much more than excel. You want, you need to ensure that it's secure and the data is accurate and there's integrity to it. But there's also a lot more that needs to go on to ensure that it's accurate, to ensure that those safety notifications go out in real time and that the date of the available for every user across the world, especially if you're running a global trial, you need to have it online, cloud-based, real time from a technology standpoint. But there's a lot more depth and functionality of features that are needed to really run a trial, to really utilize the data the best that you can to maybe find early on, maybe there is a data of signaling or data item that needs to be reviewed by the medical team early on. So using the technology to help monitor and analyze and ensure the safety of the patient and the speed of getting that drug to market. So the factor that you can have people looking at the data, the factor that you can get the data out for analysis or submission helped get that product to the marketplace faster to help patients in the end.
Emmanuel Fombu:
So with that being said, Niki, if I think about what you're saying, in my head, I'm thinking, why is everyone not using your technology? Because this is something that is necessary in every single study that we do, right? So I can imagine in one site, for example, a clinical site, where you could have different CROs, right, and the clinical trial managers on that site need to have like five different things, they need to log in into and look at different data sets. So why not just install your software like Microsoft does on Windows or Safari does for Apple. Why not just install it there and show everyone that does a study at that particular site? It's your technology. That's what Epic has done, right? And ... Has done. What do you think about that?
Niki Kutac:
Oh, I think that would be great. I think that makes it easier for the site. But it's a competitive marketplace. There are other vendors out there that do, let's say EDC, eClinical and the CRO pick different vendors based off of the features that they want to perform. But at the end of the day, that causes more work for the site. That's putting a bigger burden on the site that are really running the trials and getting the data. So being able to standardize on a product would help at the end of the day for all of the different vendors, all the different sites and organization. So that would, that's the end goal is just trying to get there, trying to.
Emmanuel Fombu:
But if we are in a space of innovation, right, and you've been in the space, you make sense to me that we have one login platform. Imagine you have to log in to like five different platforms, ... for this, ... EHR or this or windows for that and PowerPoint for that. There's like a zillion things, that gazillion passwords that you need to do, at the same time you have to prove to patients. So if we know these things, okay, from a business model perspective, I think it makes sense to install Fountayn on all the sites and everyone has to use Fountayn or not. I think it's an easy monopoly for business model to do. I think so, right, right. I mean, and I think in your space I see a lot of maybe consolidation taking place, right? To make sure it's all about the patient and make it easier on the sites so they don't burn out. What do you think about that?
Niki Kutac:
Oh, I think that the, that's definitely where it needs to go, because you are right, they are burning out and having data across different features, too. It's amazing sometimes that for trial you might have, for the same trial, you can have one EDC system, you can have another system to do randomization, you could have another system for inventory, you could have another system for imaging adjudication. And why not? I mean, our platform provides all of those within that same login. That data is entered in one time and it can be used across the different, you could pretty much turning on features. So you don't have that data movement, you don't have to have multiple logins or one day where you have to enter in the patient's information across five different platforms for the same study. So having that consolidation and that central platform that can perform that just within one trial, but then all the trials as well really will decrease the burden on the site and make their lives easier.
Emmanuel Fombu:
I'll make your promise during this chat. And I just have like this business model in my head right now, Niki, and I think we should test it out and hopefully we have results and probably a press release before this episode actually airs. But I think we'll be successful. I think if we package the whole thing together, we go to the sites and say, we'll make your life easier and then make a decision and then insist on using that particular platform, I bet you everyone else will follow along because we can't put all this pressure on them. What do you think?
Niki Kutac:
I think that sounds great.
Emmanuel Fombu:
So that's our challenge and I'll wrap it up here and that's our challenge. And I want us to continue to part two of this episode after we do it. What do you say?
Niki Kutac:
Yea accepted.
Emmanuel Fombu:
And when we do it, you have to bite the orange, we'll meet together. But ... Thank you very much and welcome to the show, Niki. We're going to bite the orange when we get this implemented. Deal?
Niki Kutac:
Deal.
Emmanuel Fombu:
All right. Thank you.
Emmanuel Fombu:
Thank you for listening to Bite the Orange. If you want to change healthcare with us, please contact us at info@EmmanuelFombu.com or you can visit us at EmmanuelFombu.com or BiteTheOrange.com. If you liked this episode and want more information about us, you can also visit us at EmmanuelFombu.com.
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About Niki Kutac:
Niki Kutac is the Senior Vice President of Product Management at Fountayn (formerly Datatrak International).
Things You’ll Learn:
Clinical trials occur to get drugs on the market.
Texas is becoming another hub for technological innovation in the United States.
Data gives insights into the drug’s safety mechanisms, dosage, and more.
Data collection also requires data cleaning.
Since every trial is different, the technology used must be flexible and configurable.