Transcript
Speaker: Welcome to Clinical Data Talks, a podcast brought to you by CRS-Cube.
Speaker: I'm your host, Sylvain Berthelot.
Speaker: Join me and industry experts as we discuss the latest trends impacting the world of clinical data.
Speaker: In our industry, there's always a lot of attention on the latest technology, but there's a gap between the shiny new object and what is routinely used by sponsors and CROs.
Speaker: I'm very pleased to welcome Dr. Marek Vagilouk to the podcast today.
Speaker: His clinical research career has taken him from CRA to being the CEO of ClinMark, a global clinical research organization.
Speaker: I'll be very interested in hearing from Marek how they implement new technology as a CRO and especially how they balance risks with providing the latest innovative solutions to their clients.
Speaker: Hi Marek, it's very nice to have you on the podcast.
Speaker: How are you?
Speaker: Hi, nice to see you.
Speaker: Nice to meet you.
Speaker: I'm okay and ready for the very, I think, inspiring and interesting interview and discussion.
Speaker: Me too.
Speaker: And I absolutely love what you have in your background.
Speaker: It looks very interesting.
Speaker: Thank you.
Speaker: That's not all because I have also medical background and also the QA background and also some other stuff.
Speaker: I'm just quite, I think,
Speaker: person who is curious of the life and curious of the knowledge and new information and competences.
Speaker: But that's actually something which drives me.
Speaker: And I think that was one of the reasons why I'm here where I am now.
Speaker: Yes, and that's also a reason why I'm really looking forward to this discussion.
Speaker: So we're going to talk about innovation and we're going to look at how you implement innovation as a CRO.
Speaker: I think it's something that we don't necessarily talk about that much.
Speaker: But looking back probably like the last five years, for example,
Speaker: What innovation has had the most impact for you and your teams when you think about data capture and processing?
Speaker: Actually, I could share with two examples.
Speaker: One is good one and the other one is maybe not necessary, but it was very important for us and also had some impact how we see
Speaker: the innovation and how we more or less, maybe not even see, but it's more how we approach or plan to approach the innovation.
Speaker: So I will start from the good one.
Speaker: We implemented the real life monitoring and review of the data for the ongoing studies.
Speaker: And this is something which is really a huge advantage for us as a CRO, and especially as a CRO, which is not a global
Speaker: top, I don't know, top 10 CRO, but a smaller one.
Speaker: So for us, it makes it much easier to steer data at the site level.
Speaker: So steer the information which we have from the clinical trial.
Speaker: So this is something which I said is really huge advantage and huge benefit for us.
Speaker: But we had also another example, which was really bad.
Speaker: We've been requested by one startup company who developed a software
Speaker: for a kind of data capture, electronic medical records, something like that.
Speaker: But the concept was not to replace the hospitals or clinics on systems, but to be kind of kept, I don't know how to call it, just that site would use it.
Speaker: individually and the system is, should be, or was supposed to be prepared per project and should be connected to the electronic data capture medical records from the sites, different sites, and then steal this data.
Speaker: So the software allowed to enter many more information than the CRF, but on the other hand was set up that way
Speaker: that it could filter this information and let's say stream part of the information directly to the CRF and the stream complete information directly to the electronic medical records at that, at every site.
Speaker: And the project was very challenging.
Speaker: And let's say the concept was quite interesting for the company.
Speaker: We've been requested to make a pilot study in cooperation with, of course, our partner and on the other hand, also with the approval of the sponsor of the project.
Speaker: And this example was, I would say, a big failure because it didn't work as intended.
Speaker: And from the business perspective, I think
Speaker: the outcome will be that no more development of this, of the project, of the software, because too much work to set up everything too complicated.
Speaker: And on the other hand, not so much benefits from the exact product.
Speaker: So that's how we see it.
Speaker: So what I want to say, comparing these two, let's say opposite example, that
Speaker: are good ideas on the market and not necessarily good ideas yeah and and that's where it must be very difficult in your position to know uh which ideas are the good ones and to know when a solution also is ready to be implemented um yeah
Speaker: Before we go into this, actually, from a process point of view, how do you approach innovation?
Speaker: Is it something that you seek yourself?
Speaker: Or is it something that you will implement relying on your partners when they suggest new functionalities?
Speaker: I would say both.
Speaker: I mean that without partners it is impossible due to different reasons.
Speaker: One, that we are too small.
Speaker: But even if there is a huge company,
Speaker: The innovation in clinical research and especially in artificial intelligence is so quick, so rapid that you have to have really purely dedicated staff which is on top of the things and is working hardly daily on that.
Speaker: So this is just impossible to do it by ourselves.
Speaker: So definitely we are working with our partners.
Speaker: But
Speaker: In terms of what to implement and how to approach and what is worth and what is not necessarily, I rely mainly on my experience.
Speaker: I'm actually a very technical person.
Speaker: I would say that I am kind of, let's say, technology geek.
Speaker: So I'm really on top of what's going on on the technology market, not only clinical research, but in general in our life.
Speaker: And we know that last year, this is the AI, which is just a huge
Speaker: boom and huge implementation and every aspect of our lives is affected now with the AI.
Speaker: So this is something which I really entered very extensively.
Speaker: So just as an example, I use over 10 AI tools on a daily basis for business and for private purpose.
Speaker: So this is combination.
Speaker: So for me, it's quite easy to see what we could find, what we could implement in our organization, our CRO.
Speaker: which would be beneficial either internally to perform better from the business perspective or for clinical trials, which we do.
Speaker: So the idea is that we are looking for something and then we are looking who has this solution and then we qualify such a company, such our vendor and agree, you know, that our unique expectations or needs.
Speaker: And then we pass that to them to develop and then we implement.
Speaker: So that's the model which we use.
Speaker: Okay.
Speaker: And do you have any staff that are focused specifically on that?
Speaker: Or is it, for example, your clinical operations team at some point may need to look into some new solutions and implement that on specific projects?
Speaker: It is not on the clinical operations team.
Speaker: We have regular meetings with the head of the functional areas, actually weekly now, and we discuss different directions, what we can do, what we do right, what we do wrong, but there is also kind of the inspiration.
Speaker: So there is always someone forced to make
Speaker: an inspiration very often it's me but not necessarily so what's going on on the market how we can let's say see on that and if it is something which is valuable so but in terms of the decision there you know this is a bit higher level so we have some people who are more let's say technically
Speaker: more familiar with technically IT staff and all this part which is related to technology.
Speaker: So there's discussion with them what is possible.
Speaker: And me, as I said, I'm also quite technical person.
Speaker: And also the new management board, which also says from the business perspective, is it worth or maybe it's too early or maybe sometimes it's too expensive or maybe it's not necessarily has added value.
Speaker: So we have both.
Speaker: I've learned that the best idea is to have, let's say, two opposite opinions.
Speaker: So very big fans and someone who is a bit skeptical.
Speaker: And then in the middle, usually is the best solution and the best
Speaker: way in which we should go.
Speaker: I like that.
Speaker: I like your approach to it.
Speaker: It's very interesting.
Speaker: So I need to bring in regulations here because as we know, we're in an industry that's very heavily regulated and risk averse.
Speaker: And when you have new solutions in mind, so for example, in clinical data capture, how do you know if it's good enough to suggest to your clients
Speaker: Okay, also, there are some aspects.
Speaker: So first of all, just that you know, I'm also
Speaker: by passion, I would say a QA person.
Speaker: So I do a lot of consultancy and also some quality audits and advisory.
Speaker: And also I'm sometimes, let's say, requested to be an independent reviewer or consultant if there are some, let's say, concerns and discussion between different companies about
Speaker: problems, which arise during the study conduct.
Speaker: So I have quite wide overview on the industry, what is going on, what is good, what is wrong.
Speaker: I also personally had opportunity, which is very fortunate for me, to look closely at many different systems.
Speaker: And I've learned one thing that rush is never a good idea.
Speaker: So there are some things which are brought up to the market, which are very innovative, very reasonable, but there are some which are not necessarily because sometimes this is just a technical thing, but sometimes also the problems with the concept of the idea.
Speaker: When we have to propose to our clients the new solution, we have to keep in mind that first of all, we have a clinical study and there are these obligations, these regulatory obligations, contractual obligations and ethics to the patients.
Speaker: So we have to be sure that the system is robust enough and the data which we get
Speaker: with usage of the system will be valuable and will be credible.
Speaker: So usually, of course, we try first of all to evaluate that internally, very often by the audit or understanding, looking at the technical documentation of the system.
Speaker: understanding how it works, just how it could be implemented in our study, let's say, usually not our study, but our sponsor study, our client study.
Speaker: And then we enter the discussion, always stating that benefits and the potential risk because at the end, the data of the clinical study belongs to the sponsor, and he has to be aware of what
Speaker: benefits and what risks are under such a task, such a system, such a decision.
Speaker: So that's we want to be always
Speaker: honest and always open to our clients.
Speaker: Sometimes even they don't want to hear us because they say, okay, you say us too much technical information or you are saying not only positive things, but also the potential risk.
Speaker: But I always say, you have to be aware.
Speaker: We can suggest what we think based on our knowledge, our expertise and what we've managed to gain.
Speaker: But at the end,
Speaker: This is your decision and you have to say go or not go.
Speaker: So it's interesting that it's always the sponsor's decision at the end of the day.
Speaker: At your end, do you get pressure from sponsors to align with the latest innovations in the industry?
Speaker: I would say it
Speaker: into two categories.
Speaker: If they are startup companies, usually they don't have any pressure because they are not enough aware unless they are approached by a, let's say, scam company.
Speaker: Because for me, that's what I said was a scam company.
Speaker: So if they are not, usually they totally rely on what we suggest.
Speaker: But with these companies, what we see over the study progress,
Speaker: that at the beginning they are very easy going.
Speaker: They usually totally rely and accept our concept.
Speaker: But then because the study is ongoing, someone from, let's say, third party companies in the world gets aware about the project.
Speaker: They are attending conferences, so they are getting a bit more competences, but not enough to understand everything.
Speaker: So they start to push during the study
Speaker: intermediate of the study actually, that maybe this should be implemented, maybe at that or that.
Speaker: We know very well that the clinical research is not only very tightly regulated, but also very complicated.
Speaker: And we have very often delays.
Speaker: So there are not so many studies which go
Speaker: as planned, I mean, in terms of the timelines and potential problems, but also a bit about the cost.
Speaker: Usually also there are some unpredictable costs.
Speaker: This is natural because it's so open environment.
Speaker: So with these companies, as I said, in the middle, usually they come and say, maybe try this, maybe try this.
Speaker: Some companies try to force it.
Speaker: Some only suggest.
Speaker: And there's another group which is
Speaker: more mature, more aware, and usually they want to implement something.
Speaker: But again, from our experience, their ideas are not always the best.
Speaker: I can give you again, some examples.
Speaker: So for instance, the electronic diaries, which are great, if they are reasonable, and if they are for, let's say, reasonable population.
Speaker: and they are totally bad if the population is not reasonable.
Speaker: So if you take older people and you force, let's say 70 plus, and you force them to complete electronic diaries, you have big non-compliance in such a study.
Speaker: This is from our experience.
Speaker: But sometimes sponsors just force, because they hear, okay, electronic diary is good because you get quicker data, you have better data, more reliable data,
Speaker: there is no sorry, risk of loss of the data, etc.
Speaker: So let's do that.
Speaker: But you know, for people at the age of 30, 40, that's fine, but not for people 70 or 80 with Alzheimer's or something like that, impossible.
Speaker: So then we enter into the discussion and suggest try really to be reasonable and go in the discussion and see our point of view.
Speaker: But we see that because this new technology and all these new tools which are brought up to the market and are existing, you know,
Speaker: you know, that tries to, you know, to implement, to use them in every study, just to say, we use this, this, this.
Speaker: And sometimes this is very beneficial.
Speaker: Sometimes this is just not necessary.
Speaker: And sometimes these are just extra costs.
Speaker: But usually in general, I can say that just to be fair that this is beneficial because this makes the studies much easier, more simpler and with better quality and everything can be done in a quicker way, usually.
Speaker: Yeah.
Speaker: I like hearing you talk about the... Now I can really picture the tension maybe there can be sometimes between technology, what a sponsor thinks could be beneficial for their study, what you at your end are ready to implement or want to implement.
Speaker: So it must be quite difficult sometimes to strike the right balance.
Speaker: I talked about balance between risk and benefits, but it's not just that, it's also balance between excitement and willingness from sponsors to be innovative and what can actually bring the right benefits for their studies.
Speaker: I can just add maybe one more word or sentence.
Speaker: It's also very different between the regions.
Speaker: So let's say if we go to Asia, clients, they are very innovative.
Speaker: They want to use everything in a new way, let's say, use new solutions.
Speaker: If you go to US, it depends, but they are a bit more balanced.
Speaker: But again, usually they won't.
Speaker: If we go to
Speaker: Europe, it is less, especially with, let's say Western Europe, when they have very often approach.
Speaker: We used to use something like that.
Speaker: I've been doing it for 20 years.
Speaker: It was good.
Speaker: So I want to keep with that.
Speaker: And this is better approach because as I said, the best approach is just to see what's the best for every study because every study is different and is different in terms of everything actually.
Speaker: Yeah.
Speaker: So in your position as the CEO of CleanMark Global CRO, is there any ongoing technology development that you're particularly excited about?
Speaker: Very shortly, AI, because this is something which everyone is excited.
Speaker: Of course, this is
Speaker: bit more at i think this i would say it's too much of the excitement right now but it will really
Speaker: maybe not revolutionized, but changed significantly how the studies are conducted because AI can be used in different areas.
Speaker: For me, the key will be the design and setup of the studies.
Speaker: So protocol design, project design, and the adaptive studies is something which is totally
Speaker: innovative and I would say totally revolution, but also with the patient recruitment, there's some support which can be used with the AI, but also with the data analysis and monitoring.
Speaker: This is something which also very much will help to get it.
Speaker: But even internally, we are now in the process.
Speaker: This is still the ongoing process of the internal development of the AI model, which aims
Speaker: to, for us as an organization to easily get access to know how, which we have.
Speaker: So, so with the usage of the AI models, we can quickly search and get information, which we gained over this, let's say almost 25 years of, of, of, of being on the market.
Speaker: So, so this is, I think it will take some time, probably half a year or something like that.
Speaker: But then if
Speaker: if everything will work as intended, we will easily get information, what we did, how to behave in such a situation, if there's a problem, this type of this type, did we have it in the past, how we resolve that, what was the approach, how to overcome the limitations, et cetera.
Speaker: So there are many things and AI Wesley use will really change totally the clinical research within next five, 10 years, I guess.
Speaker: Yeah.
Speaker: So you see AI, like you just described, the benefit for your own organization to make it faster to share information or to go back on lessons learned in a similar situation.
Speaker: Yes, and make quicker and shorten the decision path because we have data quicker.
Speaker: That's great because I've never heard anyone share this scenario of AI.
Speaker: Everyone's talking about accelerating patient recruitment.
Speaker: You mentioned accelerating setup, for example.
Speaker: But this, as an organization, I find that very interesting that you can essentially use all your experience and AI can help benefit from that experience.
Speaker: Yes, because that's the problem, I think, of every organization that
Speaker: Very often we have, you know, let's say potentially a new situation, a new problem or request for the information, how we manage something.
Speaker: As I said, we also work and personally me as a consultant and advise many companies about how to set up, let's say, more design, the studies, the projects, the programs, I would say even.
Speaker: and how to overcome and resolve the problems which has occurred during the studies, the execution.
Speaker: And there's so many information, but every time, you know, our database of the cases, of the solutions is bigger and bigger.
Speaker: And after years, you forget sometimes.
Speaker: And it's not so easy to come back and have everything in hand because
Speaker: Nowadays, I see there's so many information a day which we are pumped by
Speaker: not only the professional world, but also the private world.
Speaker: So the distance turnover is much more quicker.
Speaker: So that's something which is very valuable because I cannot count only on my, okay, I have ID, I recall that was like that.
Speaker: So, and it was brilliant solution.
Speaker: So let's say propose it and copy that, or use that for another client, for another solution.
Speaker: This is something which will be valuable, but it will help not.
Speaker: Have you started educating your teams in the use of AI and reskilling your teams?
Speaker: Yes, we started with the management.
Speaker: So on the high level, they are well, I'm inspiring them almost as I said, weekly because I am very deep in that from my, let's say, personality, due to my personality.
Speaker: So they know more and more.
Speaker: And there is one leader who is, she is actually dedicated to that and she's supporting me very strongly.
Speaker: Also in seeking for the implementation.
Speaker: So there is very often that model that I have some idea and suggesting maybe that, maybe that, and she's trying to, not trying, but sitting on that and see if it is possible to implement it, what are the benefits, what are the, let's say, limitations.
Speaker: different type of limitations.
Speaker: So we are, as I said, in the process, this is not very long.
Speaker: I mean, because we started that so deeply since more or less February or March, but already have some ideas.
Speaker: And as I said, one already in process and other in the preparation for the implementation.
Speaker: Amazing.
Speaker: Amazing.
Speaker: I love your excitement and how you seem very hands on in innovation.
Speaker: That's great.
Speaker: I've got one last question for you today.
Speaker: What's the best piece of advice you've received in your career that you keep applying to your work?
Speaker: Good question.
Speaker: And you know, the answer could be so wide from the childhood.
Speaker: I saw some, of course, indirectly because I was not directly involved, but I saw the good things and the bad things, the easy and the happy moments and difficult moments.
Speaker: So that's one thing which was very important.
Speaker: And my father said always to be consequent, believe in yourself, have your directions and try to realize.
Speaker: But if it fails,
Speaker: do not be worried.
Speaker: And he always said and always says, be brave.
Speaker: So just if you have an idea, just try to do that.
Speaker: So that's one thing.
Speaker: And from my experience and also what I see and what I've learned is that I think everyone should, especially in that current way of so many changes,
Speaker: in our environment, no matter if private or professional, just everyone should keep in mind what said two and a half thousand years ago Herakli, that the only constant thing in life is change.
Speaker: So we have to be just used to that, that the change is something which cannot be stopped and we should not stress with the changes.
Speaker: Very many, most of the people
Speaker: are afraid.
Speaker: They would like to have constant life, but it is just impossible.
Speaker: But once you accept that the change is something which is just daily, like a cup of tea or coffee, you stop being afraid and you suddenly see that there are much less problems and limitations you have in your life and you go ahead with
Speaker: let's say, bigger confidence, and you get to the point, get to the goals, to the goals you have, you, you, you obtained, you, you, you set up for yourself.
Speaker: So I think that's the key that we have to accept that the change is something which is just sure and, and not stoppable thing.
Speaker: Yeah, it's about what you can control and you can't control as well.
Speaker: But you're right, change is always going to be there, especially in our industry.
Speaker: So that's for sure.
Speaker: Yeah.
Speaker: I love what you said that your father taught you that if you fail, it doesn't matter.
Speaker: Because that risk of failure, if you're too worried about that, then that's where you don't take the risks, essentially.
Speaker: So it must be freeing to think like this.
Speaker: Yes.
Speaker: Well, Marek, thank you so much for your time.
Speaker: It's been wonderful.
Speaker: I love your energy and I'm sure your teams must really appreciate how you push them for innovation.
Speaker: That's amazing.
Speaker: Thank you so much.
Speaker: Thank you for an interesting interview and for nice words about myself.
Speaker: Well, my pleasure.
Speaker: And thank you everyone for watching us or listening to us today.
Speaker: You can find many more episodes of Clinical Data Talks on the CRS Cube website.
