Why Fragmented Technology Shouldn’t Hold Back Clinical Trials

---

Contributing Expert: Mike Novotny, CEO at Medrio

In this executive interview, William Hurth of Fierce Biotech interviews Medrio’s CEO, Mike Novotny. 

You’ll hear why Mike returned after five years away. For the first time, he says, the top technology pain point his customers have named for decades is solvable.

He explains what fragmented trial technology costs small and midsize sponsors, and how Medrio is building a connected platform to address that issue. He also covers the new Medrio CTMS, how PharPoint and other early adopters are shaping it, and why he believes clinical research is in a golden age.

Below, find an edited transcript featuring the highlights of the conversation. To hear the entire discussion, watch the video.

Questions and answers below:

• [00:52] What exciting things are happening in clinical research right now?
• [03:10] What’s the biggest obstacle holding back scientific progress?
• [03:49] What are the biggest challenges smaller companies face when it comes to technology?
• [06:14] Mike, tell me what brought you back to Medrio?
• [07:10] How is Medrio collaborating with customers to help solve these problems?
• [08:48] What’s your vision for what clinical research looks like in the future?

What exciting things are happening in clinical research right now? 

[00:52]
Well, I’m just incredibly optimistic. I believe that we’re in the golden age of clinical research and life sciences. It’s just an incredible time in terms of the technology that is coming out and its implementation. 

In the middle of the Industrial Revolution, nobody called it the Industrial Revolution because all they saw was new factories being built. I think we’re in the same equivalent now where everything that we think of as a disease, I believe, will be cured by the end of the century, or at least be very, very manageable.

I’m super bullish on what’s happening in life sciences, and I’ll give you a couple examples from Medrio’s customers. 

So there’s NKGen Biotech, which is a biotech that Medrio works with, and they’re doing research on Alzheimer’s. This has been one of the hardest therapeutic areas—the CNS, central nervous system. But they’re making progress on it now. They’re actually able to address Alzheimer’s in some of their early research. And they even think that it’s the platform that’s going to go beyond that to include Parkinson’s and ALS and be able to address a lot of things in CNS. 

Another example I’ll give you is diagnostics. I’m a huge fan of diagnostics—I think it’s the future. We’re going to diagnose things earlier and have more success. And one of our customers, QIAGEN, is close to my heart because they do diagnostics for diseases, including meningitis. My wife was diagnosed with meningitis, and she spent days in a coma and nearly died from it. And the only reason she survived is that she got lucky. She got a doctor who had just come out of his residency and was studying meningitis, recognized the symptoms, and gave her the medications right away before a test could come back knowing what she really had, which eventually was confirmed. 

So QIAGEN’s doing the same. Within two hours, you can get a test. They already have approved blood tests in 2024. And in 2026, they’re going for final approval so that you’re not guessing and getting lucky anymore. You actually know exactly what you have. And if you treat it early, then the outcomes are good. 

So those are just a couple of examples of the incredible companies that Medrio gets to work with. 

What’s the biggest obstacle holding back scientific progress? 

[03:10]
My customers tell me it’s funding. And that’s been a rough run for a few years. Funding’s been down, but it’s come back in the last 9 or 12 months. We’re seeing more funding come in, so hopefully it ends up being sustained. 

And this is something that, for my whole career, has been going up and up and then there’s a sudden crash, and there’s a flat period. Then it comes back again, and then there’s a sudden crash. And so there are definitely limits to progress. 

It’s slowing us down, but it’s not stopping us. Science is marching forward. 

What are the biggest challenges smaller companies face when it comes to technology? 

[03:49]
I founded Medrio 21 years ago and worked in eClinical software for clinical trials before that. And for my entire career, the number-one pain point our customer base talks about, as it relates to software, is the connection and fragmented software. 

Our customer base is small and mid-sized life sciences companies. The pain point is you may be using Medrio’s ePRO but then somebody else’s RTSM, somebody else’s EDC, and some other CTMS. And then you’ve got to link all this together using spreadsheets or your CTMS, whatever the case might be. Then, during and after the study, getting all that stuff to come together has been the number-one pain point every time you survey customers or when I talk to them for 30 years. 

I founded Medrio 21 years ago, but I took five years off. I didn’t think I was coming back to run the company. But I came back a year ago because I just couldn’t stay on the sidelines, because for the first time, we’re going to be able to solve that [pain point]. Medrio is building out a connected platform, so there are no more integrations. So if you create a document in EDC, it’s also then available in eTMF. 

We’re launching Medrio CTMS this month. For example, if you’re going to go visit a site, you want to know the CTMS information, but you also might need some information from EDC, like how much of the data has been monitored. So that number-one pain point of having to integrate disparate, fragmented technologies is something Medrio is solving, and it’s just what I’m super excited about. 

A top-20 pharma company I was talking with told me they are spending $100 million a year integrating one of the enterprise systems. That doesn’t count the software. That’s just their additional cost to fill in all the gaps in the software, to train their team, and so on. Our customers can’t do that. They can’t spend that kind of money to enact all the different pieces of software. And the great news is that we’re solving that. And I’m just like a kid in a candy store, excited about making that happen. 

Mike, tell me what brought you back to Medrio? 

[06:14]
I love this question. So I was CEO for 15 years, and then I stepped down for five years. I wasn’t planning on coming back, but there’s so much happening in software and in life sciences that I just couldn’t stay on the sidelines. 

The mission when I founded Medrio 21 years ago is still the same mission today. We want to make it easy for our customers. 

Our mission for the small and mid-sized life sciences companies is to make things seamless and easy to use, the way bigger companies get things to work smoothly when they spend a ton of money on systems designed for them. But smaller companies need a one-stop shopping solution too. In general, they need to have an easy experience. 

How is Medrio collaborating with customers to help solve these problems? 

[07:10]
I’m a product manager by training, so I like building software. And to me, the essential thing to that is what I call “customer listening.” We have people in Medrio who have been in the industry for decades. We have a lot of information, but we don’t count that. What really counts is what customers tell us. 

So I launched something a year ago when I came back as CEO called our Early Adopter Program, where we sign up and work very closely with our existing customers. 

The first company I called was a midsize CRO out of North Carolina, PharPoint. They’ve been around as long as Medrio has been around. We were in close collaboration. So I said, “Hey, listen. We’re building out CTMS. Will you help us? Will you get into the details with us and figure out what exactly we’re building it right? How should we change it? What should we add?” 

PharPoint’s been amazing. They were hands-on. We show them a demo of what we got. A week later, we showed them the upgrades. And so now they’ve signed up to use our CTMS along with other early adopters. 

The Early Adopter Program has just been a fantastic program for us to get really intimate feedback. There are other companies that are maybe using spreadsheets or SharePoint or other things trying to piece together a CTMS. Or if you’re unhappy with the system you’re using, then you’re a perfect candidate to be very deeply involved with being sure that Medrio is on the right path and getting you what you need. 

What’s your vision for what clinical research looks like in the future?

[08:48]
I’m a super optimist. As I referenced earlier, I think that we’re having the success we’re having and we’re going to continue to have it. I see no blockages in that. 

We’re going to see great science. We’re going to see great process. We’re going to see better diagnostic tests that are going to launch us into a very good future where we’re just eliminating every disease. 

In fact, a mentor of mine talks about how, depending on how you categorize it, there are about 10,000 diseases that could impact a human. On a basic scientific basis—like in the lab, understanding the function of that disease—we’re figuring out about one per day. That’s what’s happening globally. 

That may not sound like a lot relative to 10,000, but we already have and understand a lot of those 10,000 diseases. One a day means in three years, we’re at 1,000. So we are just steadily chipping away at understanding a disease. And once we understand it, it’s much easier to develop a medicine target for it or diagnostics for it or whatever the case may be. So I’m super optimistic. 

But it’s also true that clinical research has been getting more complicated for years. So there are more requirements from the regulatory environment. For example, the FDA wants to see live data while the study is being done rather than just afterwards. There’s dose escalation. There’s including PROs in your study. 

But I think that with companies like Medrio doing our part, our two cents in this world of making the system interconnected where the word “integration” is a four-letter word, there’s just a tremendous amount of things we’re going to be able to do to handle that complexity and bring us to this incredible future.