Beyond The Protocol

Fixing the Disconnect: Why Clinical Tech Fails Without Operational Clarity

• Melody Keel • Season 1 • Episode 9

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Clinical trials don’t derail because of technology alone—they fall short when people aren’t equipped with the tools needed to meet real-world demands

In this episode, Melody Keel sits down with Jason Spivey, Founder of Unifora and clinical tech strategist, to unpack how even the best technology can cause clinical operations to break down without the right leadership, workflows, and cross-functional alignment.

What you’ll learn:

  • Why trial delays often trace back to unclear roles—not missing features
  • How to spot the early warning signs of tech friction in your ops team
  • A practical framework to embed enablement into every stage of study delivery
  • What VPs and Directors need to know before their next platform rollout

This episode is a must-listen for clinical operations leaders who are tired of firefighting and ready to align their teams for faster, cleaner execution—with or without a tech upgrade.

Welcome to Beyond the Protocol—where authentic conversations about clinical research happen.

Hosted by Melody Keel, bringing together diverse professionals from across the industry to share insights and experiences about what it really takes to deliver successful clinical trials.

This isn't about perfect processes—it's about real people sharing real solutions.

Let's go beyond the protocol.

That's all for today's episode of Beyond the Protocol—where we explore what it truly takes to deliver successful clinical trials. 

If you found value in today's conversation, please subscribe, share with your network, and leave a review. 

Have experiences or insights to share? Reach out and be part of the conversation.

Join us next week as we continue to discover what lies beyond the protocol.

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This Podcast is Sponsored by The Research Associate Group, Inc.

Melody Keel: All right. Welcome back to Beyond the Protocol. I am so excited today to have our guest, Jason Spivey, who is the founder of Unifora and a clinical tech strategist in our world of clinical trials. And I know you and I have the opportunity to have a really awesome conversation. So I'm so excited that we get to bring that to the folks that enjoy listening in on beyond the protocol.

So I would love for you to take a moment and introduce yourself. And I think we can frame this entire episode by saying clinical trials don't fail because of bad platforms. They fail. When we, as the operations folks and the teams. Don't fully understand how to utilize them, and we're under pressure and we just haven't connected the dots properly to make it all go.

So I'm so happy you're here and I would love for you to introduce yourself and tell us about your background and how you arrived to where we are today. 

Jason Spivey: Yeah, thank you so much, Melody, for having me. I, it's my pleasure to be here. So my background is in, obviously in clinical technology of late, but it started in more of a technology infrastructure capacity.

So it's servers and networks and those types of components that you traditionally think of. And there's some strategy and solutions, as part of that work. But in a at an adjacent fashion. And not part of the. Every single day work. But after a few years of my career, that sort of started to shift into more of a strategy and solution role.

You're talking over 20 years ago now. And then about 16, 17 years ago, I had an opportunity to take a role at a pharma company, at a biotech company that's a sponsor. They're a top 10 sponsor in the industry. And it was a great opportunity when I got there the hiring manager actually.

Gave me an opportunity and say, look, we actually have a few roles I think you'd be a good fit for. We have some in digital forensics and e-discovery, those types of things. Or like monitoring of devices and again, more traditional roles. And she said, but I think you have another role here that I, you'd really be interested in, and it's around solution design and service delivery for bringing our suite of technology services in-house.

And enablement, right? For all our third parties across the company. So not just clinical research or r and d type functions, right? But marketing and legal and operations, all of those pieces. And so that was really the launching pad to get me towards clinical research. I was supporting a heavy part of that was in r and d, so clinical research and labs and all that type of thing.

And then that just headed off into more and more clinical research, and then I got into specific clinical research vendor roles and supporting. Yeah, go ahead. I have to tell 

Melody Keel: you, I have never been at a company where the role you just described that was offered to you existed, but oh my goodness, if it had, what a difference it would've made.

Jason Spivey: I tell you, I consider myself extremely lucky, not only for that opportunity because it was such an eyeopener to what my true passion is. Technology. So the reason why I went to that company in the first place is medical science is my second biggest passion behind tech. And I thought that'd be cool to bridge the two somehow.

Little did I realize how much of an opportunity I would have to really dive in that deep and roll my sleeves up over the years to learn more about all the things that go into bringing medicines and lifesaving technologies. And to. Things like that. It was such a benefit and I had such a great mentor and manager at the time who brought me into all that which I'm so grateful for because I would not be anywhere near the path I'm on now without her.

But yeah it's been such an interesting trajectory from there. 

Melody Keel: I love this. 

Jason Spivey: And the past several years I've focused specifically on clinical trials. So I've worked for a few different vendors supporting things like RTSM and eCOA and e-consent. Telehealth, those types of functions. You work heavily with study design to understand it, market for improvement, those types of things.

And then deploy your product based on the needs of the study team. And then more recently I launched Unifor a, as you mentioned, which is an independent consulting firm that focuses on the challenges we see. Across the industry for different roles. So we serve as sponsors and sites and tech vendors with the different operational gaps or the management gaps, right?

So at our core, what we do is unify strategy, delivery, and management of clinical research technology. And my career, what we saw what I saw was a lot of repeat patterns of areas or where projects would either fail or stall for a while or have to go back and do lots of rework, right? Or respend millions of dollars.

Yes. Some common gaps. And so in talking with a lot of colleagues and clients, independently without them being in the same room, I kept hearing the same message. It would really be great if someone had told us this ahead of time or if we were aware of this, or if someone had this sort of neutral oversight to steer things in the right direction, and that's how I got to where I am today.

Melody Keel: I think your journey's amazing. One, I'm not a techie. I tell everyone that, so I always line up with the ones that are the techies. 'cause that's how I get, that's how I get the job done. Yeah. Yeah. But I do wanna take a step back and just acknowledge, I think the times that we're in our industry very specialized addressing a gap and partnering with.

Companies, yes, that can come in, be nimble, flexible, and address the problem. And we don't have a lot of red tape, and we just know we're the expert. We can get this done and we can deliver results in very efficient way. And I think I'm starting to get the opportunity as a result of LinkedIn to engage with more and more companies.

Like yours and like my company where we have the ability to do such amazing things. But I feel like sometimes we may be overlooked because we're not as big, but we bring such a great alternative option to get a solution in place quickly and effectively. 

Jason Spivey: I completely agree with that, and that was why I was so excited the first time you and I ever spoke because I saw the same thing, and I see the same thing when I talk to others on LinkedIn, much like you, right?

I'm getting this opportunity now. I, we see this per proliferation of individuals or small startups that work in these types of spaces, right? Where all of these little gaps are, and I think the big driver behind that is we're seeing studies that aren't being. Put together, or they don't have the same components the same way they did 15 and 20 years ago, where a more traditional oversight model or execution model was practical.

Not to say that those places, those pieces don't have a role. They do. But I think they absolutely have a role. But there's so many more very specific. Very nuanced details that go into newer trials, whether it's things like decentralized trials or very specific therapeutic areas or therapies that are being, tested out in these trials or even academic studies.

I've seen some really interesting heated efforts there, and I think because of that's where you're seeing this need for additional support and niche support in those areas, because those are the areas that aren't fulfilled. And then teams are left kind of spinning their wheels, for days or weeks or months 

Melody Keel: or answers or solutions.

Absolutely. Yeah. I think this is a great segue into the actual technology, right? And why it's such a critical component of our trials. And I know, the buzzword is ai, but it's not about ai. It really isn't. There's so many companies that offer amazing solutions. Under the tech umbrella to help us deliver our trials in a, in the best way that we can.

But when you don't know how to put them together properly and the teams don't know how to utilize all the functionality of the systems, then it's almost what's the point? Why do we have all of this here? Why do we pay millions of dollars to bring in a company with this technology expertise, this platform?

And then we don't use it fully and we just use a little bit of it, and then we have a system over here and then, oh, we better go get this system for this and now we need to do a data review, so we're gonna go get this platform. When if you had just stopped and had an expert to strategize, right? You may have only needed two systems that you already have instead of going out and buying five more. So I would love to get your perspective of that and how you bring that expertise into organizations. 

Jason Spivey: Yeah. I think the first piece of it is really around understanding the principles of where people struggle, right?

We see lots of conversation and places like LinkedIn or in events, right? Industry events where people are talking about principles that they really need to extend. Into the clinical technology realm, right? So you have people talk about pace patient centricity, or they talk about site centricity or helping them out, right?

We're helping improve workflows and things, and then people will sell technology. But the piece that's often missing is how do you get from A to B, right? You can't just pick up technology and go, not to say again that those technologies aren't valid or useful. But a lot of teams see that stuff and they want to pick it up and run with it, and then they don't really understand how that gets put in place and 

Melody Keel: I integrated into the work that needs to be done.

Jason Spivey: Correct. And technology vendors I think, sometimes really struggle. They're very excited to work with these sponsors and sites and partner with them, but then they feel like the rate's really on their shoulders. To help them figure this out. And they don't either have the time or the right frame of mind, to really help make that technology work or the 

Melody Keel: experience and expertise, 

Jason Spivey: right? Yeah. And while some teams will sell you that expertise and sometimes that comes at a premium and that's great. Look, there are teams out there that do a great job with that. And there are sponsors and sites who have people who help them.

But the reality is many don't. That's because sometimes that need is on demand, right? So why pay a person or a team full-time when you only need certain times to bring this type of people In other times it's a functional issue. It might be a pharma that's really nuanced and focused on a key area.

And they may have 20 people total on staff. They're not gonna hire a fleet of five or 10 people. Or even one or two people constantly just to, to handle these things. So we try to come in and service them, but the way we do that is looking at what are their true goals, right? Listening to not just what they describe as their problems, but look a little bit deeper and say what's the root cause of their current challenges?

And then what's their future path, right? What's their future goals? Where do they want to get to? And then how can we bind them with the right technologies, whether that's placing them with the right technology or maybe they've already identified what they want to do or who they want to go with, and they wanna understand how that's going to work for them, right?

So we don't replace anybody's expertise. We help bring those expertise to fruition, right? 'cause we don't wanna impact anyone, or we're not here to pull the rug out from anybody, right? We wanna make that process smooth for all the parties involved. We don't want vendors to be frustrated. We don't want sponsors or sites to be frustrated.

The deployment process in itself can be frustrating. It can take months, and it's really time consuming and distracting from the work you're doing, especially 

Melody Keel: when people don't know the how. So you say, okay, we're gonna bring this. System in-house, we're gonna, we're gonna get this platform, but we don't wanna spend a lot of money, so we're gonna use the out of the box.

Which oftentimes doesn't meet what we need it to do, but we need to save money, so we're just gonna use the out of the box. And then because we're compliant and we have to show documentation of our system requirements, we need to do a UAT. But then there's no script and the team doesn't know this side of it, and so then we just muddle through and we get it to go live and then it fails.

It doesn't do what we need to do. 

Jason Spivey: Yeah. The worst thing you can do, I think the best way to sum that up, and I tell people this often, the worst thing you can do when you're investing any sort of resources into clinical technology is to do it, to simply check a box. Or to simply check boxes while you're going through that process.

If you do that you're already behind. Because you've lost your sense of purpose. You've lost the sense of how it's going to help your end users, whether that's patients or site personnel or data analysts, right? So you really have to keep your eye on the prize the whole time as you're going through that process.

But in fairness to everybody involved, that can be really difficult. Your job's already busy enough with everything you're doing. And then, as we know, study startups or even, technology initiatives in general. They rarely stay on a straight path when you're going through all these things, right?

It, it needs the right attention to focus. And a lot of I hate to overuse this term 'cause people sometimes misuse it, right? But people talk about North Star initiatives and things, right? Oh yeah. And that's something I think is really important when you choose a technology or a technology strategy.

Melody Keel: Agreed. Because if you don't, you end up. It just came me a tech spot, a tech stack flop. That's what you end up with. It's essentially in your organization where you've gone out and you've not had a strategy and you've select all these pieces and components of different platforms and it just flops because nothing works together.

Jason Spivey: Yeah. It's such an interesting, it's such an interesting piece because you have the tech stack to worry about. You don't want that to tumble over. But at the same time, you have to consider your people. So it's really an operational stack in a sense, where technology is a part of your foundation, but you have to figure out how you're going to get your people to work with it.

And because you have people from different backgrounds and skillsets and different focuses with what they're doing, you have now your job is two or threefold because you have, you can't just come up with one. I see sometimes people will really focus on. Yeah, we're gonna, sell people on this and get buy-in and get the who, so maybe the sponsor or the study people running the study, maybe they have buy-in, but your site team doesn't, or vice versa, maybe site teams are all in.

And that's a feat in itself sometimes because they're all over the place and really busy. But you get their buy-in, but then it doesn't help patients or it doesn't help the biostats people that they're getting all this data and they're saying, this isn't helpful to me. I didn't ask for this.

So you have to do things in a way that are. Be efficient and as smooth. I can't say things will be perfectly smooth 'cause this industry's just so turbulent. But you don't wanna invite the opportunity for more turbulence, right? Or 

Melody Keel: more chaos. Yeah. Yeah. Yeah, and I think it's a really good way for us to talk about the people behind the tech and the platforms and the systems and the strategies that we decide to bring into the organization.

Because a lot of times what I hear is, okay, just train everybody. And it's not about training. It's literally not about training. So I wanna hear how you feel about training versus enablement. Like, how do we really make sure. From an operational perspective, our teams are ready to manage and handle the tech strategy that gets deployed into our organization.

Jason Spivey: Yeah, there's a lot of components that go into that. So I think the first piece is having champions and buy-in from your population, going into it, if they already have a very negative feeling going in to start for whatever reason, prior experience and things like that, you have to find a way to turn that around.

Yes. And so I think having a strong champion from leadership. Who can help break, bring a more positive feeling to your audience. That's the first part. Because now anything else you involve them with is going to make them much more receptive. Yes. And then from there you really have to work on the awareness part of it.

Which means, giving them context around why they're getting involved with this technology. Why is this being brought in, or what's the future mode going to look like? 

Melody Keel: What problem was it solved that's gonna help you in your day to day? 

Jason Spivey: Exactly the true value. I think a lot of people get caught up in looking at how can we make this platform work?

How can we make it look nice? How can we make it easy to use? And that's an important component. But if even not the only one, not the only one. If that's the only thing you're doing. It's still a great to use platform, but it doesn't provide value and benefit for its users. People are still going to ask what's the point?

Because they're still going to have to take that time to learn it, remember it. And in this industry, it's not the only platform they're using. It's not the only study they're on. There's five or 10 or 15 other things they're using and they're not using it full-time, so they have to come back for a refresher later.

All those different components. So it's really important for them to understand what the benefit is, how it fits into their operations, right? Their day-to-day job or their weekly job when a patient comes in for a visit or whatever it is, right? I think also helping in the case of sites, helping them understand how it's helping patients.

That's important because I've heard, sadly, stories of patients who go to sites and they're there and they're trying to talk to the site and the person is a cheery person, but then they have questions about, oh, what is this software? What's this app you're telling me to download?

Or, what's this form? And sites will say, I really don't know, or I'll have to get you the answer. And patients are. Befuddled by that sometimes, right? So having that sort of preparation and context and things like just in time training or reminders or tool tips that are within platforms that help people quickly remember what it is they're doing right now, or what to enter, or what's the step right behind this, right?

So again, for contextual awareness, I think those are all big factors. 

Melody Keel: I agree, and sometimes just a little common sense sprinkled in. I was visiting a site last week and helping they're new to research and so I got the opportunity to go down. It was wonderful. And something that struck me asking just for user manuals, she said is there a, like a user guide that you can give me for this system?

And I remember not that long ago. Vendors did have, you had user guides for study coordinator. The sponsor. Like different roles that the system had, but that seems to be going away. And I had to tell her no. And then I went to the vendor and said, do we not have this available for our site staff? I'm like, oh, just send a question in the help functionality in the system.

And I'm like, that's not common sense. Why don't we just have a guide to get them initial. WI mean through the system when I need to do X, before I go to the level of reach out to the help desk. And it was embarrassing a little bit for me to have to say, oh, there's no user guy for you, even though you're new and you're just now getting in the system.

We don't have that. 

Jason Spivey: Yeah it's amazing how often this has actually become a hot topic lately. A lot of people are talking about how do we improve, investigator meetings and the SIV process and things like that because those are the, exactly the types of gaps people are seeing more and more of.

And not only, I think platform specific user manuals. Study specific manuals, right? People, so often people are just leaning on the protocol and saying, just do what the protocol says. But as we know, besides being a massive document there's a gap in what the clinical protocol is.

Versus what an op, an operations manual, not only for the site, how they operate is a little bit different than what just the protocol says. Yes. But then if they're using the technology as well, there's some sort of guidance that needs to be behind that to say Exactly. '

Melody Keel: cause the protocol gives us the study.

But it doesn't necessarily, again, we take what we need from the protocol and we build our systems. We pull in the data points we need or what we need to collect here. But that doesn't always translate unequivocally right. To the protocol. And so we just can't say, go look at the protocol 'cause that doesn't give us what we need.

Jason Spivey: No, that's exactly right. It's again, it's all around context. People being having different ways to quickly understand what it is they need to do, but why not just how, but why they're doing that. And I think when you add that piece in, that makes things move much more fluidly. 

Melody Keel: Agree. I agree.

And I think when you add that piece in and you look at it from that kind of bird's eye view, it also takes us over to leadership and how do we bring leadership in? They're the ones that approve the use of this technology and these platforms, and they open up the budgets for us to bring this technology into our teams and our departments.

But then how can leadership utilize the same platforms? Because a lot of times what I find is we have all of these systems. They do give an output. We can get metrics, but then we get the same questions from leadership over and over again. Or they want a separate dashboard built, or we have to present it in a slide deck every week.

The information's right here in the system. Like we can get our leadership to see what they need to be able to report in their world what's going on with the trials. And so I would love to know your perspective how leadership can play a role in this as well. 

Jason Spivey: So I think so I think leadership has two big important roles, right?

One is, of course, understanding the benefit of a technology or a technology strategy overall, right? Understanding where they really want to go, what they're, what problems they're trying to solve, what benefits they're hoping to realize with this. I think oftentimes, again. Leaders are very busy people too.

Yes. And they get swept up in sometimes the flashiness of an, a option or a solution that's out there for them. And on paper it sounds great, they have to really understand what's the realized value to come from this. So I think taking the time to work with the team, a leadership team or a project team.

That can really help flush those things out a little bit more. I think leaders should feel really empowered to not have to put that entire weight on their shoulders. And if they wanna start a committee. To go out and look at, what are the problems we really need to solve, or what options are there to bring things in-house or, I don't mean necessarily in-house, but to bring things into our operating model, right?

And make the success, what are those things? Rather than, a quick one-off decision because there's pressure to move, especially you mentioned AI earlier. I think we see a lot of that right now. Now that AI can't bring. A lot of value potentially. But sometimes there's this pressure, I think especially because it's such a buzzword Yes.

To shoot from the hip in decisions, to Oh, that sounds, that one sounds really good. We need to bring that in because that's going to sound great in a few. Exactly. So I think, one piece is to tell leaders to be a little bit more metered. But not feel like they have to, body that all themselves, right?

That to bring in other people and their team, bring in your science officer, bring in your clinical ops director, right? Police people like that to, to help work together and figure out your problems and your paths forward. And then the other piece of that is I think really understanding and that goes hand in hand at the first, which is understanding what are your metrics.

For understanding success. So when you talk about dashboards and things like that whether it's overall for your overall strategy or you're talking about metrics for a specific study, knowing where you wanna go, I think the biggest people joke a lot about dashboards. I'll make a comments about, oh, that's great that you're selling a new platform, but how many dashboards does it have?

Because that's what people always ask about. But so many dashboards, I can tell you, melody, they go unused. People will obsess about wanting them to exist in a platform or somewhere. And then they're never leveraged because they know that it's important to have quick analysis, visibility into statistics like that. But there's not necessarily a lot of thought given again about what is the value about that, or what is my target for what I'm trying to achieve. So I think the best thing you can do for those pieces for dashboards and analysis is again, understanding what it is you want to achieve with that information, right?

And then use that to work backwards and say, okay, this is my goal. 

Melody Keel: Yes. 

Jason Spivey: Now these are the metrics I need to measure that goal, and then this is how I need to display. And then, okay, programmers, right? Let's go build a dashboard, or let's find a platform that has these dashboards or can email a dashboard summary so that I don't have to go log into a system, right?

If it's anonymized data and things like that. So 

Melody Keel: I feel like that's pressure testing the strategy before you decide that this is how we're going to proceed forward. You really get the opportunity to make sure this is. What we really need. That's such a big part. Instead of doing that on the back end.

Jason Spivey: Yeah there's people think about, like you told, mentioned UAT, right? So people, and that's an important piece, making sure your technology's working and meets user's requirements. I think having the right user requirements though. Is the more important part if you, again, if you're checking the boxes because they're steps, but those steps don't really have any contextual meaning to what you're doing for your study or what you need it to do.

What you need it to do, right? Then what's the really the benefit you're spending all that time going through a process? Isn't actually bringing you value. So it's just that same concept, right? Applied at different stages of your technology adoption process, right? You have a high, very high level process you have to look at.

Then you have very, niche level or a detailed level. Steps in that process were, how does it serve the patient? How does it serve a site? How does it serve an, even a data analyst or data manager? All these different components. And then of course, at the end of the day, you have to say how do all of those in individual pieces serve my broader strategy?

Yes. And so for a site that might be their strategy might be, or their goal might be making their operations more efficient or taking workload off of their site staff. For a patient they're not really in charge of this, but they're going to be more likely to, that helps them. People forget that just because you get a patient in.

It doesn't mean they're staying. And poor technology, AB adoption can realistically lead to massive. 

Melody Keel: I've seen it at times that don't work or what need to use technology for a population that's older and not as tech savvy. And you don't have a paper option. They're forced to use an iPad or an app and then they're like, forget it.

Jason Spivey: Yeah. And I think and I think that's like a common example. I think the biggest piece to that because there are some cases where those populations even can, will enjoy the benefits 

Melody Keel: of technology at times if we have it set up properly. Exactly 

Jason Spivey: right. That's the piece people forget about.

So people will say, look, it worked really well in this study. I always point to, yes. But go back and look at how that study was designed or look at how that technology was implemented and you'll see why that was a great fit and why there was such benefit realized. Yes. In that particular study, for every one or two of those, I can probably name five or 10.

That may have been a disaster for that same population and 

Melody Keel: that we're pressure testing. We didn't pressure tests. We just assumed it would work because it did for this study. 

Jason Spivey: Exactly. So those are things that leaders need to really be privy of, is having open dialogue with the rest of their team and the teams that their team work with, right?

To understand, what are these problem areas? What are we really trying to solve for? And then once you have that target or set of targets right now, that's what you can execute against and that's your. If that's your grounding or anchoring factor that you can continue to go back to and bring things right and make sure you're really on the right path.

Because if you have no single point that you're focused on and you're going through your study startup process or your technology deployment process and you don't know what you're supposed to be looking at. It's like you're on a ship, right? And you're, you've been in the storm, or it's a cloudy night if you don't have a star, that's what North Star came, right?

If you don't, if you don't know what you're supposed to be looking for in the first place, or it's going to be a rough day. Yeah. Or a rough week. And then, if you lose traction on that or I've even seen, where platforms do a major overhaul mid deployment or mid study startup.

And yeah. So what you bought into. Three months later isn't right. It's totally different by the time you actually go to launch. And so that can be a very stirring situation and I feel like we're bringing up, all the me scenarios. But 

Melody Keel: yeah, that's why you need the expertise and the strategy.

And as a leader, one of the scenarios I see over and over again is the decision to invest in technology for our trials and our programs, but. We oftentimes don't truly understand what the investment requires for the platform to do what we need it to do. And so we make an investment, but it may not be enough to get the system to be as robust as the vision we have it to be.

And so we get it, we set it up, and then we start to use it and we realize we need to invest more. To upgrade for it to work the way that we need to. And so again, we didn't pressure test the strategy. We've made an investment, we don't have more to invest in it. And so we, our platform that now the team says, we're just gonna sit this over here and go back to what we were doing because even though it wasn't as efficient and we really would like to have technology to support it, we're just gonna go back to our old way.

And then you have systems and platforms and technology that's just collecting dust. We're paying a vendor for that system that's not being utilized. And I think that's something leaders should really make sure we've got a proper strategy, that we pressure tested and we know the system's going to provide the capabilities that our organization and teams needed to do.

Jason Spivey: Yeah, that's completely true. Look, the reality is, and this is gonna sound a little harsh but user experience goes beyond what's on the screen. It's about the impact the technology's having with everyone involved. And to your point, if you're only saving 20% of your time in one area. 20% of your effort or your cost in one area, but you're doubling the burden for your sites and you're doubling the burden for your patients, that's a huge negative impact.

You failed at that point. Yeah. You, and you don't understand the role that technology is meant to have in your study or you don't have the. Capacity, the resources or the experience, right? To understand how to make that technology work for you. And you don't want that failure, which I think is why teams are sometimes reluctant to invest in the technology.

They know it's a big question mark, and they know that if they miss the mark, that's a big loss. So I think in some ways people who are hesitant are, at least, I would say they're wiser in some aspect because they understand the. The negativ, the negative impact that can come if they're off the mark.

However, you can't just sit still waiting for the perfect solution because you're also never going to iterate and make any sort of improvements. So you have to be strategic about when you make those leaps. Maybe they're not great leaps. Maybe sometimes you're making little jumps or just little steps.

But calculate it. Calculate it. Great. And that can common increment, people think sometimes, they like to think in terms of 10 x improvement. And guess what? 10 x improvement sometimes comes with 10 x more cost. Yes. So you have to really pick and choose your opportunities for advancement there.

And that can come in different ways. It's not just if people talk about monetary spend, they don't think we, when we, we're talking about people, often they don't talk. Think about the people spend, the people costs. That comes with a poor implementation or a poor decision. Not just the time, right?

People sometimes will think about, oh I wanted to do some, I didn't like that. I had to hear. Doing, I couldn't, I have, it was gonna take me 12 weeks, I pushed for six weeks. Now it's taking me 36 weeks. Yes. Because I pushed things too fast. And so they may think, and this doesn't even happen sometimes, but they may think about that gap.

But what I think is often missed is the time consumption of your users. If you're con if you get buy-in and you're moving forward, but it's very poorly designed or implemented. Your burden and your subsequently your time in investment from all of your users. Yes. You know that. And that's every time they go through that same task.

So if it took them twice as long and they do that task 10 times a day or 10 times a week. That's right. That's exponential. And it, that's not extra one user. You have a thousand users across your study because you're a big global study now that's happening every time. And if your dropout rates for your study are high.

For the same reasons, right? 

Melody Keel: Costs are not only immediate financial, it impacts your recruitment, your retention trust in you to be able to run this program. And then where you ready to go and do another program? Is the psych gonna be as excited to continue? Because it was really hard this last time with those types of challenges.

So it's just, it has a domino effect for sure. 

Jason Spivey: Yes. Yeah, absolutely. I think that's a lot of what. Negative impact has a domino effect, but so does positive impact. Yes. And I think that's the real key to all of this is when you're looking into this, that's your purpose. Yes. Is understanding why are we spending a little more time now.

And short term pain for long-term gain is really watered down version of that. Saying, Hey, if we take a few more weeks to think about this and really what we're trying to achieve. That's really gonna get us at the door much more quickly in the long ride. Sustain us 

Melody Keel: on the positive side longer, right?

Jason Spivey: Yeah. And that's not just, again, for the immediate financial benefits or the immediate timeline projections and things, but that's gonna be your ongoing domino effect impact. Your sites are gonna be much more happy, your patients are gonna be much more happy, and that's just for momentum for your future studies.

Absolutely. Opportunity. Better. Better. Absolutely. Which is what, that's what's important. 

Melody Keel: Yeah. No, I think this has been an incredible discussion, so I'm so glad we did this today. And I wanna leave on a positive note. I really would like to know what do you see as, for great things in terms of technology and this intersection between tech and clinical and moving our trials forward?

Jason Spivey: I think the biggest thing technology is going to serve us in the next few years is better automation and better insights. So people, I don't want to use the term AI 'cause I think people overuse that for a lot of different things, or they think that's going to be a genie in a bottle that they're unlocking.

But in some cases it will be ai. I think I'm actually writing a piece right now talking about intelligent automation and how that people will throw the AI label on that. But they're really two different things and I think yes, cool technology tools that give us better insights into our data and keep things on rails a little bit more fluidly are really important aspect.

I think where we need to be careful is including human in the loop and not forgetting where humans play a role in all of this. And so we have to find interesting ways. I think sometimes people talk about human in the loop and they quickly want to they want humans to just serve as a check box, right?

And say, okay everything looks good. But I think there needs to be a nice, strong interaction. But I think those things are coming. I think the people that work with that are coming and they're gonna refine their skillsets, and I think new technology that works with humans. Not in place of humans. I think you're going to see more focus in that.

Supporting patients, again, supporting sites, supporting data management type roles. Those things are coming and I think that's really exciting for people. And what we're going to be work, what you're gonna see people working through in the next few years is refinements to that. 

Melody Keel: Yeah. I love that.

And I love to hear the opportunity for. Retooling of the professionals that have the subject matter expertise and how they can view themselves as becoming the solution to technology moving forward, they'll be part of that. And not 

Jason Spivey: is people are going to I think by force. But I think we're seeing that willingness now.

There are early adopters now who were sitting there saying, how do I not just push a product, but how do I really leverage technology? For a benefit and understand how to make it work for my team or be a champion for my company, right? To help others get on board and elevate them to that level and make technology work for them.

And I think that's something we're gonna see a big change in the next, where we are five years from now. We're 2030. Can't believe it's 2025 already, but I. Will be very different because we will already be so much further down the line in terms of as humans, how we perceive technology.

Much the difference between the early nineties Yeah. And late nineties, people's perception of the internet and all that was two wildly different things. And I think we're gonna see that with how technology benefits us in business and especially clinical research. 

Melody Keel: I agree. I agree.

Thank you Jason. It was great having you. I think this was an awesome discussion and I hope everyone gained some nuggets and feel more informed about technology and how we're using it. 

Jason Spivey: Me too. Thank you so much, melody for the time and this was a great conversation. I look forward to talking with you more in the future.

Melody Keel: I too. Sounds good. 

Jason Spivey: Thank you so much.

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