Sylvain Berthelot, Calyx
Sylvain Berthelot is the Senior Voice of Customer & Stratefy Director at Calyx, one of the leaders in eClinical and Regulatory technology. In his role, Sylvain aims to transform customer feedback into insights and decisions that will positively impact trial teams, sites and patients.
Sylvain has assumed various roles during his 12+ years at Calyx, and he consistently kept his focus on reducing burden for sites and patients. He is the host of the podcast Calyx Café, where industry experts talk about clinical research trends, futurology, and best practices to reliably solve the complex in clinical trials
This week we discuss the often underappreciated role of IRT in clinical trials, the concept of “site approved” technology, and the zen of surfing.
+Full Episode Transcript
Brad: 00:02 All right, Sylvain. Thank you so much for coming on, man.
Sylvain: 00:06 No, thank you for having me. I'm a big fan of the show, so it's nice to be on.
Brad: 00:12 Well, and I love you know, before, we sorta just talked beforehand, I thought you were in Canada, you're in the UK. So I appreciate it's probably gettings getting towards the end of your day there if I had to guess.
Sylvain: 00:24 We're, yeah. Getting towards it, but I still have a couple hours, soall good
Brad: 00:30 I'm still waking up and you're, you're starting to wind down, so I like that
Sylvain: 00:34
Brad: 00:42 Yeah, you can just point and laugh and say, Haha, my day. Yes,
Sylvain: 01:07 So, interestingly, it wasn't quite by accident by hear a lot of that a lot as well. For me, so I went to Uni not really knowing what I wanted to do because of that, I wasn't very successful at Uni cuz I didn't have any goal. But I didn't like failing
Brad: 03:01
Sylvain: 03:05 It feels like it.
Brad: 03:07 Yeah, it it sneaks up honey. You, doesn't it? No, I mean, look, I can relate, you know, I didn't do well in college because I, you know, was an 18 year old kid and I had no idea what I wanted to do at all. So it's, I think it's pretty relatable actually. But I do find it interesting that you found a program that was, I mean, sounds like perfect for kind of what you're doingnow or the, the, you know, role that you kind of got into, right?
Sylvain: 03:30 Yeah, pretty much. And it was very, very well done because there was a lot of time spent in the industry during those three years overall. I think after the three years, I probably spent 10 months in the industry and that was what really taught me a lot, Obviously then I had my first job. I didn't know how to do it.
Brad: 04:05 Yeah, That's cool. I mean, I don't know that I, I'm sure there are programs like that here in the US but I don't, that doesn't ring any bells to me. It seems like that would be something that would be in high demand or, you know, at the very least, something we need to see more of. You know, we, we do have a lot of people entering the, the field still by accident, but, you know, a lot of people coming in kind of completely fresh with no real idea of how the industry works, which is
Sylvain: 04:35 Yes. Yeah. And I've seen a lot of people like that. Yeah. which require a lot of training when they come in.
Brad: 04:43 Yeah. Yeah. And I mean, it must be frustrating too to, I mean, on the one hand, I appreciate the enthusiasm a lot of people are coming into the industry with and wanting to, you know, change the game or be a disruptor or whatever the case may be. But then it must be frustrating to be like, Oh, this is actually really complicated and
Sylvain: 05:17 Yes, I did so well, Perceptive Informatics became Parexel Informatics. So I think when I joined, actually, we'd just been acquired by Parexel, and Calyx became Calyx from splitting from Parexel at the beginning of 2020 no, sorry, 2021. So I spent more or less 11 years within Parexel, which for me was like, it really gave me the opportunity to see different aspects of the, what we do for a clinical trial. But then I, I also saw that the vision from a CRO is a certain vision and that sponsors will have a different vision. Thankfully they meet somewhere, but it's very interesting when you start, like in my role now, I spend a lot of time interviewing sponsors and end users. And like, you, you get that people come from different angles and then you understand why sometimes there are conflicts because not everyone sees it in the same way as the others. So yeah, it is very interesting and I love our industry for that because we have such a noble role in society, but we don't all go about it in the same way, although we all try to achieve the same thing. There are so many different ways that people approach this goal that we are all aiming for. It makes it, Yeah. Even more interesting.
Brad: 07:02 Yeah, I'm, I mean, it's something I've, I've pointed out a lot is that, I mean, there's so many roles contain, like, if whatever you love, there's something in the clinical trial industry you can, you know, relate to or, or I think get on board with, because to your point, it's, we're all working towards the same thing, but there's just so, there's such a breadth of different things to do
Sylvain: 08:26
Brad: 10:45 Yeah, I mean that's a, something I've been pretty keen to now for a while, is the, the disconnect between buyer and user, right?Which I think trickles down into a lot of interesting issues. But, you know, IRT specifically is an interesting one to me. I know when we first started talking, I was sort of like, Huh, IRT is like, I guess I don't, you don't think about it that much from the site level. I mean, I guess that's a good thing, right? That means it, it works because, you know, I, I've, I mean, I can tell there are clear differences between some of the systems, but unless it's not working, it's almost you're just, like you said, you're in and out within, you know, a couple of minutes, you're done, your drug shows up when it needs to, it spits out the right, you know, numbers that match up to a kit somewhere. And you know, it, it all works. But there are certainly differences between the systems, how easy they are to use and how you know, how much also just sort of how much useful data they can give you as a site. I mean, what, what, what sort of sets Calyx apart, like the, from your, from your experience from other, other IRTs. Cause I think sometimes it can be tricky for sites to know like, Oh, well, who cares? They're all just kinda, they're all just kind of the same
Sylvain: 12:03 Interesting question. So from a a site's point of view, what we, what we try to do is to give access to the tasks that sites need to do. So what's interesting in an IRT is that, you know, the dispensing visit schedule, so based on when a patient was randomized, you know, when they're meant to be coming, give or take three days for the next visit. So you can actually like start showing to the sites what's coming next. And like what's key for us is like this being in and out within two minutes. Like it's giving access to the functionalities they need straight away so that they can really be going, Okay, you need to dispense this, and that's it. Then I come out of the system. But then there are aspects as well that sites don't see. And what I love about what, like I r and what we do in the industry is that sometimes we spend a lot of time and a lot of effort so that people don't see what's happening.
Brad: 13:57 Right. Yeah. Good point. Good point. Yeah. To the site, everything looks like business as usual, which yeah. Would be, that'd be a success at that point.
Sylvain: 14:05
Brad: 14:16 Yeah. No, again, I think that's yeah, I like that nuance. I've never thought about it that way. I, and again, even to your point, some, something that maybe is as simple as getting a visit window when you dispense a kit is, I mean, that's great for a site. If I can not have to go do a calculation on my own and only to find out later, I go to dispense a kit and it's like, Oh, you're a day out of window. Well crap, why didn't you tell me that before? You know, why couldn't I know that beforehand? Which is the case with a lot of, you know, IRT systems out there. Something as sort of of simple as that could be a huge advantage for a site. You know, avoiding protocol deviations and avoiding misdosing and things like that. Again, simple but elegant, you know? I love that.
Sylvain: 15:04 Yeah. Yeah. And we do a lot of work working with sites directly, which like, considering they're one of the key actors in the, the clinical trials, they interact with patients. For me, this, that's how we help patients in a way, cuz I t doesn't touch patients directly, but if we help sites get it faster than we help patients in a way that's, that's the way I see it. So yeah, we spend a lot of time like interviewing end users to, to make sure that the way we build the system is, is useful that we display the right information that we give access, as I said earlier, to, to the right functionalities. And that's something that, so I, I'm a big dreamer
Brad: 16:11 Yeah, no, I, I love this and I've, I've talked about this for a while. There's just a lack of, I don't wanna say it's lack of transparency, but it's a lack of communication. Like between, cuz you know, sites talk to each other, but there's not a lot of public information and certainly not a lot of public conversation cuz I guess people are afraid to speak badly of different technology solutions. But I, I think we do need more of that because, you know, if a CRO or sponsor doesn't know that particular vendor is just terrible. I mean, it's hurting sites, it's hurting patients, it's hurting their studies. So if we could come together in some way to say like, look, these are good solutions that we want and these are bad solutions that we don't want anymore. Which I think to your point, would encourage more companies to work directly with sites because you can tell from a site level what's been built without any site input. It's pretty easy to tell like, Oh, this is not for me, this is for, this is for the CRO or sponsor, even though I'm the one who has to use it. You know, So I I love that idea. I mean, I'm curious what that would look like because many patients have no idea what they're using. If I hand them a E-diary, they don't know what the company is, they don't know who it's coming from, it's in a lot of ways becomes more of a reflection on the site. Cuz all they know is the site I'm giving them this old Android phone with one app on it that doesn't open up half the time it crashes and it won't connect to their wifi. And they think that's me doing that
Sylvain: 18:05 I think it starts with your research. So like if you have interview sites in the process or even like an diary, you could work with patients and hopefully E-diary vendors work with patients. And then I think there would need to be some sort of validation with the sites as well of the end product. And if you've spent this amount of time developing it with the sites and get some sort of stamp that a site or several sites have used a better version of your system and that you've taken into account their feedback, then you could have a site approved lable. I mean, you could do the same with patients. I think with patients it becomes a bit more difficult, but involving end users in the validation of your system is something that should be part of the process, in my opinion.
Brad: 19:09 Well, I think to your point too, a way to sort of standardize and validate that process rather than just saying like, eh, we talked to a patient, they liked it, you know like make it more stringent and you know, follow some sort of some standard process. So that, I think again, to your point, it would be good to know probably not just from the site side, but from a customer, CRO, or sponsor would want to know, you know, if a vendor has gone through that, I mean, I have to think that affects the success of their trials maybe more than they can appreciate. I know that if I'm using a system in a trial and it's terrible and I mean I'm, I'm just a lot less likely to focus on that trial cuz it's a bad experience for me and for the patient. And again, I think that sometimes may be very underappreciated by sponsors and CROs. If I say, Hey, your E-diary sucks, we can't get it to work. The, the patients hate it and they're like, eh, too bad use it. And I'm said, well, I got five other studies, so I'm gonna go work on those because patients want to be in them and they're easier to work with. I mean, again, I think maybe that isn't being appreciated enough.
Sylvain: 20:16 No, and it's terrible to, to even get to a point that you, you think like that by completely get why you would, because if a system is taking too much of your time is not working, is making patients reconsidering, taking part in the trial, then why bother? But do you think, so at your, at your end, do you think you can influence sponsors? Like are they listening now to sites or not?
Brad: 20:48 You know, it's hard to say. I, I will say that there appear to be more sponsors, CROs, vendors, reaching out and, and trying to engage sites. It's hard for me to tell if that's having any real effect. I mean, I certainly have not had any sponsors come to me and say, Hey, we're trying to choose between these vendors who do the sites? Like, I mean, I haven't had that level of, of engagement, but more of like vendors saying like, Hey, can we bounce some ideas off of you, we'd like to do this or that or the other. So it's getting a little bit better, but I think it's hard to see yet if it's having any real practical effect on, on what's happening or what vendors are being chosen. I still think that probably a lot of this
Sylvain: 22:34 Yeah. That, that, that would be a very good way to approach it because they obviously, so the sponsors will use part of the systems as well and they will ask their end users like, how is it for you? So why not ask other end users even if they're not in your organization? There's something that frustrates me actually because like when you look at the, the industry in general, there's a lot of focus in making the life of employees easier, like caring for your own employees, which I think is great. But then sponsors have this role of selecting systems that you use on a daily basis. So like, they should also look to make your life easier and the patient's life easier. Right. And I know, I mean, I know there's a, this thing about decentralization being the, the holy grail of making it easier for, for patients, but I don't really see it as being the, this wholesome solution.
Brad: 23:45 Yeah, no, I mean, again, it's it's being a little oversold at this point probably. I think it's gonna have a much more narrow application than sort of what it's being made out to be. There's still gonna be, you know, you can't be doing trials with colonoscopies and surgeries and you know, a lot of, you know, unless they just completely change how clinical trials are done, which I don't
Sylvain: 24:46 Yeah.
Brad: 24:47 And you can't do it without them.
Sylvain: 24:49 Nope.
Brad: 24:49 Sites love their patients. We're walking these people through their journey of a clinical trial. I mean, we bust our asses to work with them and help them. So make it easier, make it easier for all of us. You know, just talk to sites. I've used, we're, we've done a hundred trials over the last few years. We've worked with seven different E-pro vendors. We've got a lot of experience like working with different systems. So, I mean, and we're not even that big. So go talk to some of these sites. They'll, they'll tell you who they like to work with.
Sylvain: 25:17 Yeah. Yeah. That's interesting. I was talking to site pharmacists not so long ago who told me, Oh, I used 10 IRT, at the moment because of all the studies we work on, and I can't start imagining having to use 10 different email systems
Brad: 25:52
Sylvain: 26:28 Yep. Not me.
Brad: 26:31
Sylvain: 26:42
Brad: 26:45 Yeah. It, it, again, it's very challenging. But no, I love the idea of having some mechanism by which you can say, look, patients and sites have vetted this software or solution and they like it. I mean, do you think that should be done, like outside or just like independently that should possibly be taken on by maybe some sort of site consortium or, or some other movement? I mean, there's no reason that couldn't be done like independently of, of any vendor or, or sponsor. Yeah?
Sylvain: 27:14 Oh yeah, definitely. And I think, I mean, even if, so for example, thinking about myself, I'm very interested in doing something like this. I'd like to be involved, not necessarily to influence the output and like make sure that Calyx would be voted higher than others, but just to have the process in place. And I think you're right, that having a consortium of sites maybe other users or I don't know what it could look like, but having this group that would review that a certain piece of software functionality has been validated by sites. And it shouldn't be something that is very difficult to do. Like for, for that consortium, just sharing some, I don't know, validation report or something like that. And then you have your site approved label and then a sponsor could still go, No, I don't want to use that. But then it's their choice and, and I think it becomes more obvious, which vendors make the effort and care about their end users more than others. It's a bit like buying eggs that don't say free range. You can still do it. It's, it's your choice.
Brad: 28:39 Yeah. Yeah. Well, and again, at least you've created some sort of standard to start picking through the
Sylvain: 29:04 Yeah, and like, there's so much innovation you can do as well. So like vendors end up not differentiating this much from one another. And sometimes what, what makes sponsors set it to certain vendors is not what they do better than others. It's what they get right and that others get wrong. So yeah, I don't know if, if we are going to see this change in the future. I mean, when I joined IRT there were probably five key IRT vendors and that was all. Now we are getting towards the 20 mark
Brad: 30:02 Right. Well it sounds like 10 or so years ago, there was a lot of consolidation with, cuz you know, I, I remember a lot of these IRT vendors who have all disappeared and rolled up underneath, you know, some other company. But now it's like happening all over again. Every now there's more. Do you think there will be another round where they all start to consolidate to some degree?
Sylvain: 30:25 Possibly. I mean, it's very hard to tell but I don't think, I don't expect there to be much more new vendors because it's going to become not worth the investment if the like, market share between vendors gets tiny.
Brad: 30:45 Yeah. Well I have to think that's already a concern to some degree. Cuz again, I mean, yeah, how many do you need? How many do you need? I guess competition's good, but at some point, I mean, someone's gotta go away, right?
Sylvain: 30:58 Yeah. Yeah.
Brad: 30:59 Well, fair enough. I wanna, I wanna shift gears a little bit if you're okay with that. Something I like to ask all my guests, you know, what's maybe a, a tool or a resource or something you use kind of in your, your everyday life? It doesn't have to be research related, but something that kind of makes you you know, some helps you be the best you can be. It can be anything. Again, book, podcast I dunno, exercise, breathing techniques, anything. What, what's, what's a resource or something you use that's really invaluable to you?
Sylvain: 31:32 That's an amazing question. So for me it's, I'll reply with two different, well two things that are related but kind of different exercise and nature. And I try to combine both as much as possible. But I, I love running, so being outdoors running really helps me get some space in my head. And it's not unusual for me to start a run feeling stressed and then suddenly during my run I'll find a solution to a problem. I wasn't even thinking about
Brad: 32:18
Sylvain: 32:18 And then you get home and you're like, Oh yeah, no, that's good. That did, that didn't me good
Brad: 32:50 Yeah, no, I think there's a lot of things in that space that are sort of just create a little bit of a meditative quality where to your point, you just kind of shut your brain off and you're doing something physical, which requires some, some attention. So your brain stops having a bajillion random thoughts that it's oftentimes having throughout the course of a busy, busy work day. Yeah. And it just allows you to, to find a different, you know, find a little bit of a flow state, a little meditative state where you, you can calm down and, you know, I'm very guilty of having to remind myself of that when you know, I'm stressing out throughout the day and I'm like, okay, we need to need to step away and do do something physical or again, being in nature to your point is, is great and just sort of like
Sylvain: 33:56 Yeah. Yeah. It's interesting you said slap in the face. So I started surfing last year which is not something I was expecting to, to start in my forties, but hey
Brad: 34:54 Yeah, no, I, I agree. It's sort of like I don't know if you're familiar with like Wim Hof and you know, cold submersion. I mean yeah, that's a big interesting thing to me too. It does, it can definitely change your head space and but to your point, you have to force yourself. You have to force yourself outta your comfort zone a little bit sometimes to get the, the benefit that comes along with, with doing hard things. Right. I mean that's that's, I think there's some real beauty beauty in that. Well, fair enough. Where can people find you online?
Sylvain: 35:28 So I'm on LinkedIn so Sylvain Berthelot on LinkedIn. They can also find Caylx Cafe my podcast on Spotify. I think we're on Apple and other streaming platforms. And we also have our own site where we store the, the podcast. Yeah, I think that's about it.
Brad: 35:51 Yeah, definitely. I mean, I'll put all your info in our show notes, but definitely go check out Caylx Cafe, the ridiculously awesome production on that.
Sylvain: 36:00 Thank you
Brad: 36:00 I think really unparalleled. I would, I yeah, you're really trying to put us all to shame with your production quality, but
Sylvain: 36:10 That's not the initial goal,
Brad: 36:13 No, no, I know. But again, you guys do a really nice job. I'd I I do appreciate the the aesthetic and I think it's really cool to, to see that, cuz you know, we don't have a lot of that. I mean, there's not a lot of content and useful content creation in this space anyway, but, so I can appreciate the extra effort, put some nice aesthetics in there, but
Sylvain: 36:32 Thank you
Brad: 36:33 No, look, I really appreciate you coming on. You have any kind of final words as we wrap up?
Sylvain: 36:38 Well, I think we've had a very good discussion and love this topic. I think we should carry on the discussion to see if we can do something about getting those site approved labels at some point.
Brad: 36:53 Yeah, I love that. We'll definitely talk offline and I've got some possible thoughts towards that cuz I think there'd be, I think there'd be some real interest in that too, from a, you know, a big segment of the industry. So. All right. Well Sylvain, thank you so much for coming on and I'm sure you'll be back before we know it.
Sylvain: 37:12 Yeah, Thank you, I really enjoyed it
Sylvain: 37:12 Yeah, thank you. I really enjoyed it.