Transcript
Speaker: Welcome to Clinical Data Talks, a podcast brought to you by CRS-Cube. I'm your host, Sylvain Bertelot. Join me and industry experts as we discuss the latest trends impacting the world of clinical data.
Speaker: With over three decades of experience across sponsor and provider organizations and a lifetime achievement award to show for it, my next guest brings a rare 360 degree view to clinical trial technology.
Speaker: Having worked alongside him during our time at Calyx, I can vouch for his deep expertise firsthand, though I'm mostly just glad we became such great friends in the process.
Speaker: In today's episode, we're sitting down to unpack a pivotal industry topic, sponsor growth and its direct impact on clinical technology.
Speaker: It's a great pleasure to welcome the founder and principal consultant of IRT Advisors Group, Craig Mooney. Hi, Craig. I hope you liked the introduction.
Speaker: Thank you very much, Sylvain. It's great to see you. And I did like the introduction, particularly the acknowledgement of our past working experience that has turned into a friendship. And I'm very excited to to to be on today and to and to support the cause, right, of talking about clinical data and clinical technology.
Speaker: So thank you for asking. Well, thank you for joining me. i i don't know where this is going to go. i know i know we love talking to each other. And what I like is that we don't necessarily agree, but we're we're always better for having the discussion anyway. So yeah looking forward to it.
Speaker: And what brings today's discussion is that you recently wrote an article with another of our friends, Joan Munoz-Pujol, that is titled Choose your heart, an honest look at standalone IRT platforms. In the article, you laid out ah a truth for our industry and I think for people who may not have read it yet. Could you break down that core premise so that they can understand the why this discussion today?
Speaker: Yeah. So first of all, the like with you, this article, your our our relationship and our interactions, this article came out of a genuine discussion between Joanne and I about the tension between sort of standalone providers who provide maybe one or two technologies such as IRT and providers who perform who provide a platform, which has a lot of different services across a unified platform.
Speaker: And my experience in my past life working at a large pharma had always been one of, well, I always go for the standalone product and that's what my experience was has been. And in in trying to expand my horizons and think, well, but why do I do that? what is the Why do I think that that's so and so important? and having two colleagues and friends that work for, you know, an organization that provides a platform that will let me let me talk to Juan. Let me learn about this and the way and the way he can see it, having worked at both. um And I think that the tension or what we came back with is very specific to say there is no right answer.
Speaker: Right. And I know that sometimes I can be unsatisfying for people like, well, should I choose this or should I choose that? And I think there are, and so we use the, I use the phrase, choose your heart, which means, which is a way of saying, no one answer is perfect. You either are choosing, in my phrase, you know, a provider that's focused on one thing for a particular set of reasons, or you're choosing a platform which focuses on many things and they each give you advantages and disadvantages over the other. And you have to choose for yourself.
Speaker: Well, what's the most important thing for me, for my organization and possibly even at the level of a particular study? Why does it matter? And so I just and trying to become in the consulting business, it's important not to just have one view and say, oh, this is the way you do it. It was really about trying to understand and expand what the possibilities are in, you know, sort of clinical trial technology.
Speaker: Yeah, and I really enjoyed the article because In a way, I like it that you you didn't conclude because everyone should get to their own conclusion, like you said. ah But the way I read it made me think, well, it's interesting because there seems to be a point from what I see where oh when a company grows, so a sponsor or CRO, they might
Speaker: move from using ah platform to using different systems that are more specialized um ah And so that that really made me reflect on that. what Why is there such a thing like that? um And I wonder if you, from what you see in your consulting work, if you see the the same and if you have a feel for what that tipping point is.
Speaker: Yeah, you know I do. I do see the same. where it's and To me, it comes down to where decisions get made.
Speaker: right like who's that We used to have this saying when I worked at BMS, who has the D, which means who has the decision. and I think in a smaller company,
Speaker: It's a very top-down approach. have a small organization, you have a CEO or a vice president of like say clinical operations who has domain over just about everything. I will say, obviously have domain everything, but at a smaller organization, they're involved in just about everything, right? It's a size and scale where they can be looking and saying, we wanna do this, we wanna do this, we wanna do this.
Speaker: And ah I think a a smaller organization, they become more attuned to streamline. right like In other words, you're like, well, if we have one approach, for example, a platform, then we don't have to have four or five different vendors and whatnot. And as organizations expand and get larger, i think those decisions are pushed down more into the operations.
Speaker: So now instead of having sort of one leader or a small group of leaders making a decision about, well, what's our approach going to be to IRT, EDC, TMF, you have operational folks who are saying, well, this is my area of expertise.
Speaker: So now I want to make the decision about what we do or what we don't do. And I think that's the point at which they get to a certain size and those decisions now have to be dispersed and people are empowered to make their own decisions. And so they say, well, if I'm responsible for it, then I'm going to go out and I'm going to make the choice.
Speaker: That's sort of how I've seen this happen and I've seen this happen. throughout my career, you know, no matter which side of the, when you know, we were together in our past life, you would see this too, like, oh, who owns this? Oh, now I know. Now I know why they're talking to us because of who owns it or why they're not talking to us because who owns it, if that if that makes sense.
Speaker: I think you've described it very well that the bringing the decision layer down means that in a way, then your technology selection becomes siloed.
Speaker: Yes. And because it's siloed, you don't you don't care about the same things. And we saw it together IRT where We wouldn't talk to data managers, for example, because they don't care about IRTs. And they weren't buying the IRT, right? they They weren't the buyers. So why would we need to talk to them? We should have an idea about what they do, but they're not the people we're talking to.
Speaker: No, and it but but then it's interesting because data managers get data from IRT. Bringing the decision layer down means that in a way then your technology selection becomes siloed.
Speaker: Yes. And because it's siloed, you don't you don't care about the same things. And we saw it together IRT where We wouldn't talk to data managers, for example, because they don't care about IRTs. And they weren't buying the IRT, right? they They weren't the buyers. So why would we need to talk to them? We should have an idea about what they do, but they're not the people we're talking to.
Speaker: No, and it but but then it's interesting because data managers get data from my RT. So I find that extremely interesting. and And so do you think it's the like the the silo comes from this division into departments?
Speaker: or or Or do you think it's like the the technology, because you also have point solutions, does it also reinforce the silo in a way?
Speaker: You know, I think if I look back through what I just said to the previous question, I think silos come first.
Speaker: I think as organizations grow, then they say, okay, well, we just can't possibly all keep our eyes on the same thing. You know, think about, I've, you know, when I had my own for a couple of years, I was ah a business partner in IRT company.
Speaker: We had a customer, it was like six people in a compound and all six of those people were on every single call that we ever did. um And obviously at at scale, that just becomes, that becomes impossible to do.
Speaker: So I think the silos are created first and people aren't having, now there are people who put in a position whose job it is to see across those silos. you know Like in clinical operations, you know you sort of have the compound lead who's supposed to be looking across those silos, but those silos still exist and they're all working independently.
Speaker: I think the technology choices they make reinforce those silos right just like we were talking about before if i'm if i'm in clinical supply i'm gonna put the product that focuses on clinical supply i think where it so the circumstance of where the opposite could happen where the technology could drive a silo might be if you have a bad outcome So let's say you're a mid-sized pharma company and and like I'll mention IRT because my area of expertise. And IRT is given off to somebody who's like, oh, I did that once in my past life. I'll look over i'll look after IRT and then something goes really bad.
Speaker: then it's like, okay, now we can no longer treat this. And I love to say, you know, moonlighting. Now we can't have someone moonlighting an IRT. We have to have someone who's dedicated to that and we're going to give them the responsibility for making sure that happens. So I would say typically silos are created at scale, but a bad outcome can also create a silo.
Speaker: Does that make sense? Yeah, yeah it does. and It's a very good point because then, yeah, if you if you give responsibility to someone, it doesn't go well, then you take that responsibility away from them.
Speaker: And an IRT is a very good example because if it doesn't go well, usually it really doesn't go well. Right. Yeah. It puts trials at risks. Yeah. And I've seen that literally, literally that example, people have said, we had to bring someone in because we we got our IRT wrong.
Speaker: And I imagine the same thing could happen in eighty see a number a number of a number of different areas Yeah. Well, it's interesting for me because I moved from IRT where, and you know that very well, I've told you that already, where I was focused on point solution and really seeing the benefits of that.
Speaker: to a platform where it's really changed the way i look at trial data.
Speaker: um Not saying that there's a better or or a worse one here, by the way. But what I find very interesting is that we've talked about silos, selection of technology, but then your data becomes siloed as well if you move from a platform to point solutions.
Speaker: And to compensate, what we do is integrations which require a lot more um stitching, I would say.
Speaker: Yeah, I like that word too, stitching. That's a good word. um But there are there are benefits of having point solutions despite breaking down your data capture into siloed inputs in a way.
Speaker: From your point of view, we can take IRT as an example as well again. What benefits do companies get from choosing their own?
Speaker: point solutions that outweigh having to stitch the data back together? Yeah, it's it's a really interesting question because i return to the context that you know weighing what's more important, not important depends on the individual buyer.
Speaker: Right. So I think sometimes the perception and my experience, and again, I'll talk about IRT, is that for IRT, When it comes to a point solution, i think it's more fully featured in the clinical supply area, right?
Speaker: Um, and I, I think platform providers are focused on data. Like that's, I think that even because EDC usually sits at the center of a, of a, of a platform, it's like the first place that people are like, okay, we're to have a platform. We really need to be in with EDC and every decision they make sort of is relevant to that Genesis as it were. It's like, okay, we're gonna, we're gonna manage data here.
Speaker: um
Speaker: But it's not always the case. You know, I'd say, in my learning about platforms, right? And and I credit you too, for like, when i you know, I did this thing called IRT Insights Initiative where I was gonna go look at IRT providers and talk about what they do. And you say, hey, don't forget the platforms. And I did, and I included them. And I've been learning a lot. And I would say for a vast majority um of studies, lots of studies where there isn't a great distinction between whether you do use, whether you need to use that standalone
Speaker: versus versus a platform. But at the edges, there are and it's about feature set. It's always about feature set. Think about it this way. if If you're developing a platform, you're trying to have a holistic view of the entire clinical development lifecycle and that perspective. If you're a point or a unique provider,
Speaker: you are laser focused on the one thing. And that means that you will probably have more experience in that thing. So you will have seen more design elements. You will have seen more crazy, sophisticated um resupply algorithms.
Speaker: um I'll also say that even some of the platform providers, they're actually just doing the same thing by sharing data behind the scenes. right I know that's not the case with the organization, but I do know that there are some, it's like it comes across as a platform, but really they're moving data just like a point-to-point organization would.
Speaker: um And so you sort of lose that where you're like, well, I'm not really getting that. What I'm really really getting is just a skin that looks the same. um So I think if you were, again, it comes back to the buyer. If you're not a buyer who's focused on data, but you're a buyer focused on clinical supply algorithms and those sophisticated then you might more likely go and say, Hey, I'm going to get a point to point solution. Now that's just for IRT, but I imagine the same thing's true with, um, with other parts of a platform. And I imagine that there there will be point where
Speaker: if you don't have a point solution, there may be workarounds, if we think about clinical supplies. yeah And the point solution avoids having to do that manually. yes because Because then those workarounds can be quite difficult, labor intensive.
Speaker: yeah So yeah, yeah, yeah, I do. Yeah, but I'm shedding my, you know, I'm trying to be as, as a sort of not agnostic, maybe that's not the right word. and I'm being more and more open now than I, than I maybe was maybe a couple of years ago when perhaps you and I worked together, you know, now I see value across the, across the spectrum of different types of providers.
Speaker: So I'm converting you. That's what I'm saying. You're educating me. Conversion is an all different thing. ah I want to talk about data reconciliation because we've had many discussions about that. Yes, have.
Speaker: And that's another trade off when you have point solutions, you get data from different types of technology, uh, and you need to make that data match at the end of the day. Uh, but you always bring up a great example. So please share that example. Cause I love it.
Speaker: Yeah. I just, you know, I think the primary thing you have to know is you need to know what your system is supposed to be doing, right? And what is it built to do and not confuse it with any other type of system.
Speaker: IRT is built to a so randomized patient and assigned drug to make sure the right drug gets to the patient. the right patient at the right time every single time. That uses data to achieve that goal.
Speaker: It is not a data management system. And I think the the example you're talking about that I love to to talk about is visit date versus transaction date.
Speaker: You know, in in in the IRT, as I said, is built to do those things.
Speaker: Someone goes into an IRT system in order to get something back. you the material number, for example, they're not going into register a visit. So oftentimes, when a transaction occurs, is not the same date as when the patient shows up.
Speaker: Some sites might use the IRT system the night before, so that they're prepared for their early morning visits to make sure that they have that material. And you will see a lot of companies come back and say, Oh, the visit date in the IRT is wrong. It needs to now match the date that the patient showed up. i'm like, well well, that's not correct. The date in the IRT is correct. It's the date of the transaction. It's not the visit. And all of this to say, people just have this blind obedience to data reconciliation without really understanding what each system is doing, what is its purpose,
Speaker: What is the system of record for a particular data point? um And I think So much time, money, energy has been wasted in the pursuit of reconciliation. Now, what I find interesting about a platform, which is kind of funny because when I talk about point solutions, I tell people like, you know in my past big pharma career, we did very little reconciliation and we sent very little data to the EDC from the IRT. It was like three data points, the same data points, every single study without exception. So we got, you know we were good at it.
Speaker: But smaller companies have this like, oh, we have to reconcile everything. That's where I think a platform actually benefits them, right? Because now they don't have that.
Speaker: Even if they have that sort of feeling, oh, my God, we have to reconcile everything. The platform means they don't have to have that internal argument about where they should or shouldn't do that.
Speaker: reconciliation because it's all it's happening in real time. They don't need to reconcile that data. So going back to the article you wrote, choose your heart.
Speaker: I feel like, ah and you may not agree with that, so tell me what you think, but I feel like it might not necessarily be a binary choice in a way. ah Because when we started this conversation, i thought, well, it's either you're a company for point solutions or you're a company for platform solutions.
Speaker: But maybe there's a middle ground. What do you think about that? When you say you're a company, you mean you're a provider of or you're a consumer of? You're a consumer of. Yeah.
Speaker: It's funny when I was... So... I would say my answers are no, there there is no binary choice. i don't think there's an ah ideal choice.
Speaker: It depends on a number of factors, which is a frustrating answers. Like people wanna know, hey Craig, platform or standalone? I'm like, well, tell me what your situation is and and I'll tell you maybe what is better you. think that um i think that Now, I do think it is an organizational philosophy and discussion based on size and what you value and all the things I said before, who owns it? you know So I think organizations make a decision, hey, we're gonna do a platform, A, we're gonna do point to point solutions.
Speaker: But if you were to throw away the confines of an organization, At a study level, you could say, hey, for this study, the platform makes perfect sense for us you know because of the type of the design of the study or whatnot. Or no, for this study, we actually, because of the specialized circumstance, we do need you know a point solution.
Speaker: um I don't, i don't so I'll reflect the market. I don't think large pharma in the market is deploying platforms as much because of the tension, what I said about who's buying it and where those decisions get made.
Speaker: Now I will say, talking about specific providers, I think there were opportunities or there were in the mid 20 teens, late 20 teens, when platform was was making a sort of showing itself, they were selling sort of what i would say at the C-suite level, like, hey, you know we're gonna try to help you across all your stuff and this is great one solution. Um, but it didn't quite take because of the way these larger organizations are organized.
Speaker: Um, so I don't think i think now it sounds like I'm umm sort of stepping on my own words. It doesn't have to be a binary decision, but it sometimes is.
Speaker: Um, and I think that has a lot to do with the size of the organization and who the buyer is. Um,
Speaker: and I think it also can evolve. I don't know, maybe. So, um hey, I'm going to ask you a question. Have you seen customer your customers leave because they've got bigger and decided to go?
Speaker: Or have you seen bigger companies come to you because they're like, hey, we tried the specialized and we now want to go towards the more more platform level? I don't think that we've seen any of that.
Speaker: Okay. I don't think we've seen any of that. And I think probably because of this divide maybe between the type of companies who are interested in a platform and the type of companies who are interested in a point solution. Yeah. So you see it the same way, right? like Yeah. Yeah. Okay.
Speaker: yeah
Speaker: Wow, the tables have turned. I'm answering questions. I'm sorry. I'm like, oh man, I asked you a question. Sorry. ah But no, I love it. I have one last question for you.
Speaker: Sure. I'm asking everyone who comes on the podcast, what's the best piece of advice that you've received in the past and that you constantly apply in your work?
Speaker: So it's funny. I don't know where I got this piece of advice, um but I say it all the time. And probably when I say it, you're going to be like, oh, yeah, Craig says that all the time.
Speaker: And it's two of them. The first is no $10 solutions to $2 problems, right? Which means do not over and engineer your solution to your problem, which sort of lands in the discussion we're talking about here, right? Like, hey, do I need to over engineer this? No, I don't. This this this thing works perfectly fine. I don't have to go and do this very complicated thing.
Speaker: And the other is about root cause. and And I would say in a project or when someone would come or post something, I would say, well, what's the actual problem you're trying to solve for?
Speaker: you know Or said differently, is this a solution looking for a problem? um and In my career, i have seen these had things happens all the time. $10 solutions to do a lot of problems and someone says, oh, we we need to do this. and I'd be like, well, okay, why? what What are we trying to solve for? Why is this a thing?
Speaker: and I'm surprised at the number of times people have a hard time articulating you know clearly. Why? why you know, and whatnot, or they're focusing on the wrong thing. Or so I think that's maybe about root cause. So those are and I again, I can't remember where are they where they came from.
Speaker: um But and I'll add another listen, you're asked for one, I'm going to give you three. The other thing I learned and this probably maybe applies to what you guys is at one point, someone asked me why I wasn't buying more of what they were offering. I said, it's not that I'm not buying what you're selling. You're not selling what I want to buy.
Speaker: And I think as a business owner, that that makes me always think about like, am I focused on what I want to sell? am I focused on what my customers want?
Speaker: And in my you know In my consulting business, I constantly ask myself that question, like, hey, Craig, remember, which is why it comes back back full circle about talking about the difference between platform and you know point solution is saying, you I have to understand why both are helpful and where both one shines versus the other and then try to help a customer come to the decision that's best for them instead of saying, well, this is my position. This is what you use. You should just use that. So sorry, I took you on a bit of a journey there.
Speaker: Yeah, but you've summarized think the conclusion we came to very well, actually. So I really like it. um oh oh surprised Were you surprised by those? kind You've heard me say those things before, right?
Speaker: I have, I have. But yeah, I like them. Well, thank you, Craig. i yeah It's interesting because I didn't know where this was going to take us. And and I feel like we've ah we came to the right conclusion. So I like it.
Speaker: Yeah, I really appreciate it. And i I love talking to you and I talk to you anytime anytime I can. Yeah, that'd be great. Me too, me too. Thank you. And thank you all for listening or watching today's episode. You can find more on the CRS Cube website.
