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Striking the right balance between risk and innovation with Marek Wasiluk
7 Plays4 months ago
Sylvain Berthelot welcomes Dr. Marek Wasiluk, CEO of ClinMark. With a career that spans from CRA to leading a global CRO, Marek brings a unique perspective on how clinical research organizations can embrace innovation while safeguarding trial quality.
Together, they explore the fine balance between adopting new technologies and managing operational risk. Marek shares how his background in medicine, quality assurance, and clinical operations shapes his approach to implementing digital solutions that not only meet regulatory expectations but also bring real value to sponsors and patients.
Sylvain and Marek discuss why CROs must be both cautious and bold when evaluating new tools, how to build trust with clients while innovating, and the importance of curiosity and adaptability in driving meaningful change.
Tune in to hear how CROs can move beyond “shiny new objects” and take a thoughtful, balanced approach to innovation in clinical trials.
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Transcript
Introduction to Clinical Data Talks
00:00:14
Speaker
Welcome to Clinical Data Talks, a podcast brought to you by CRS-Cube.
00:00:19
Speaker
I'm your host, Sylvain Berthelot.
00:00:21
Speaker
Join me and industry experts as we discuss the latest trends impacting the world of clinical data.
00:00:30
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.
Marek's Journey to CEO
00:00:47
Speaker
I'm very pleased to welcome Dr. Marek Vagilouk to the podcast today.
00:00:53
Speaker
His clinical research career has taken him from CRA to being the CEO of ClinMark, a global clinical research organization.
00:01:04
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.
00:01:25
Speaker
Hi Marek, it's very nice to have you on the podcast.
00:01:29
Speaker
How are you?
00:01:31
Speaker
Hi, nice to see you.
00:01:32
Speaker
Nice to meet you.
00:01:33
Speaker
I'm okay and ready for the very, I think, inspiring and interesting interview and discussion.
00:01:41
Speaker
Me too.
00:01:42
Speaker
And I absolutely love what you have in your background.
00:01:46
Speaker
It looks very interesting.
00:01:48
Speaker
Thank you.
00:01:51
Speaker
That's not all because I have also medical background and also the QA background and also some other stuff.
00:01:58
Speaker
I'm just quite, I think,
00:02:01
Speaker
person who is curious of the life and curious of the knowledge and new information and competences.
00:02:10
Speaker
But that's actually something which drives me.
00:02:12
Speaker
And I think that was one of the reasons why I'm here where I am now.
00:02:17
Speaker
Yes, and that's also a reason why I'm really looking forward to this discussion.
Innovations in Data Capture and Processing
00:02:24
Speaker
So we're going to talk about innovation and we're going to look at how you implement innovation as a CRO.
00:02:34
Speaker
I think it's something that we don't necessarily talk about that much.
00:02:38
Speaker
But looking back probably like the last five years, for example,
00:02:44
Speaker
What innovation has had the most impact for you and your teams when you think about data capture and processing?
00:02:59
Speaker
Actually, I could share with two examples.
00:03:03
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
00:03:12
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.
00:03:20
Speaker
So I will start from the good one.
00:03:22
Speaker
We implemented the real life monitoring and review of the data for the ongoing studies.
00:03:29
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
00:03:39
Speaker
top, I don't know, top 10 CRO, but a smaller one.
00:03:42
Speaker
So for us, it makes it much easier to steer data at the site level.
00:03:48
Speaker
So steer the information which we have from the clinical trial.
00:03:52
Speaker
So this is something which I said is really huge advantage and huge benefit for us.
00:03:56
Speaker
But we had also another example, which was really bad.
00:04:00
Speaker
We've been requested by one startup company who developed a software
00:04:06
Speaker
for a kind of data capture, electronic medical records, something like that.
00:04:14
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.
00:04:31
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.
00:04:50
Speaker
So the software allowed to enter many more information than the CRF, but on the other hand was set up that way
00:04:58
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.
00:05:15
Speaker
And the project was very challenging.
00:05:17
Speaker
And let's say the concept was quite interesting for the company.
00:05:21
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.
00:05:34
Speaker
And this example was, I would say, a big failure because it didn't work as intended.
00:05:41
Speaker
And from the business perspective, I think
00:05:45
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.
00:05:57
Speaker
And on the other hand, not so much benefits from the exact product.
00:06:04
Speaker
So that's
ClinMark's Approach to Innovation
00:06:05
Speaker
how we see it.
00:06:06
Speaker
So what I want to say, comparing these two, let's say opposite example, that
00:06:12
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
00:06:37
Speaker
Before we go into this, actually, from a process point of view, how do you approach innovation?
00:06:47
Speaker
Is it something that you seek yourself?
00:06:50
Speaker
Or is it something that you will implement relying on your partners when they suggest new functionalities?
00:07:02
Speaker
I would say both.
00:07:04
Speaker
I mean that without partners it is impossible due to different reasons.
00:07:11
Speaker
One, that we are too small.
00:07:12
Speaker
But even if there is a huge company,
00:07:15
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.
00:07:32
Speaker
So this is just impossible to do it by ourselves.
00:07:35
Speaker
So definitely we are working with our partners.
00:07:38
Speaker
But
00:07:39
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.
00:07:49
Speaker
I'm actually a very technical person.
00:07:51
Speaker
I would say that I am kind of, let's say, technology geek.
00:07:56
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.
00:08:03
Speaker
And we know that last year, this is the AI, which is just a huge
00:08:09
Speaker
boom and huge implementation and every aspect of our lives is affected now with the AI.
00:08:16
Speaker
So this is something which I really entered very extensively.
00:08:19
Speaker
So just as an example, I use over 10 AI tools on a daily basis for business and for private purpose.
00:08:26
Speaker
So this is combination.
00:08:28
Speaker
So for me, it's quite easy to see what we could find, what we could implement in our organization, our CRO.
00:08:38
Speaker
which would be beneficial either internally to perform better from the business perspective or for clinical trials, which we do.
00:08:47
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.
00:09:00
Speaker
And then we pass that to them to develop and then we implement.
00:09:04
Speaker
So that's the model which we use.
00:09:06
Speaker
Okay.
00:09:07
Speaker
And do you have any staff that are focused specifically on that?
00:09:14
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?
00:09:27
Speaker
It is not on the clinical operations team.
00:09:30
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.
00:09:45
Speaker
So there is always someone forced to make
00:09:47
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
00:10:09
Speaker
more familiar with technically IT staff and all this part which is related to technology.
00:10:16
Speaker
So there's discussion with them what is possible.
00:10:19
Speaker
And me, as I said, I'm also quite technical person.
00:10:23
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.
00:10:36
Speaker
So we have both.
00:10:38
Speaker
I've learned that the best idea is to have, let's say, two opposite opinions.
00:10:44
Speaker
So very big fans and someone who is a bit skeptical.
00:10:47
Speaker
And then in the middle, usually is the best solution and the best
00:10:52
Speaker
way in which we should go.
Innovation in Regulatory Frameworks
00:10:56
Speaker
I like that.
00:10:56
Speaker
I like your approach to it.
00:10:58
Speaker
It's very interesting.
00:11:01
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.
00:11:11
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
00:11:23
Speaker
Okay, also, there are some aspects.
00:11:25
Speaker
So first of all, just that you know, I'm also
00:11:30
Speaker
by passion, I would say a QA person.
00:11:33
Speaker
So I do a lot of consultancy and also some quality audits and advisory.
00:11:39
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
00:11:57
Speaker
problems, which arise during the study conduct.
00:11:59
Speaker
So I have quite wide overview on the industry, what is going on, what is good, what is wrong.
00:12:10
Speaker
I also personally had opportunity, which is very fortunate for me, to look closely at many different systems.
00:12:20
Speaker
And I've learned one thing that rush is never a good idea.
00:12:25
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.
00:12:44
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.
00:12:59
Speaker
So we have to be sure that the system is robust enough and the data which we get
00:13:07
Speaker
with usage of the system will be valuable and will be credible.
00:13:14
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.
00:13:28
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.
00:13:37
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
00:13:53
Speaker
benefits and what risks are under such a task, such a system, such a decision.
00:13:59
Speaker
So that's we want to be always
00:14:02
Speaker
honest and always open to our clients.
00:14:06
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.
00:14:15
Speaker
But I always say, you have to be aware.
00:14:18
Speaker
We can suggest what we think based on our knowledge, our expertise and what we've managed to gain.
00:14:25
Speaker
But at the end,
00:14:28
Speaker
This is your decision and you have to say go or not go.
00:14:35
Speaker
So it's interesting that it's always the sponsor's decision at the end of the day.
00:14:40
Speaker
At your end, do you get pressure from sponsors to align with the latest innovations in the industry?
00:14:53
Speaker
I would say it
00:14:55
Speaker
into two categories.
00:14:56
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.
00:15:08
Speaker
Because for me, that's what I said was a scam company.
00:15:11
Speaker
So if they are not, usually they totally rely on what we suggest.
00:15:16
Speaker
But with these companies, what we see over the study progress,
00:15:21
Speaker
that at the beginning they are very easy going.
00:15:24
Speaker
They usually totally rely and accept our concept.
00:15:28
Speaker
But then because the study is ongoing, someone from, let's say, third party companies in the world gets aware about the project.
00:15:39
Speaker
They are attending conferences, so they are getting a bit more competences, but not enough to understand everything.
00:15:46
Speaker
So they start to push during the study
00:15:50
Speaker
intermediate of the study actually, that maybe this should be implemented, maybe at that or that.
00:15:56
Speaker
We know very well that the clinical research is not only very tightly regulated, but also very complicated.
00:16:03
Speaker
And we have very often delays.
00:16:05
Speaker
So there are not so many studies which go
00:16:09
Speaker
as planned, I mean, in terms of the timelines and potential problems, but also a bit about the cost.
00:16:14
Speaker
Usually also there are some unpredictable costs.
00:16:17
Speaker
This is natural because it's so open environment.
00:16:20
Speaker
So with these companies, as I said, in the middle, usually they come and say, maybe try this, maybe try this.
00:16:27
Speaker
Some companies try to force it.
00:16:29
Speaker
Some only suggest.
00:16:31
Speaker
And there's another group which is
00:16:36
Speaker
more mature, more aware, and usually they want to implement something.
00:16:43
Speaker
But again, from our experience, their ideas are not always the best.
00:16:48
Speaker
I can give you again, some examples.
00:16:49
Speaker
So for instance, the electronic diaries, which are great, if they are reasonable, and if they are for, let's say, reasonable population.
00:17:00
Speaker
and they are totally bad if the population is not reasonable.
00:17:04
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.
00:17:15
Speaker
This is from our experience.
00:17:18
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,
00:17:27
Speaker
there is no sorry, risk of loss of the data, etc.
00:17:30
Speaker
So let's do that.
00:17:31
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.
00:17:41
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.
00:17:51
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,
00:18:05
Speaker
you know, that tries to, you know, to implement, to use them in every study, just to say, we use this, this, this.
00:18:11
Speaker
And sometimes this is very beneficial.
00:18:13
Speaker
Sometimes this is just not necessary.
00:18:15
Speaker
And sometimes these are just extra costs.
00:18:17
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.
00:18:31
Speaker
Yeah.
Regional Preferences in Tech Adoption
00:18:34
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.
00:18:59
Speaker
So it must be quite difficult sometimes to strike the right balance.
00:19:03
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.
00:19:20
Speaker
I can just add maybe one more word or sentence.
00:19:25
Speaker
It's also very different between the regions.
00:19:27
Speaker
So let's say if we go to Asia, clients, they are very innovative.
00:19:33
Speaker
They want to use everything in a new way, let's say, use new solutions.
00:19:41
Speaker
If you go to US, it depends, but they are a bit more balanced.
00:19:45
Speaker
But again, usually they won't.
00:19:46
Speaker
If we go to
00:19:48
Speaker
Europe, it is less, especially with, let's say Western Europe, when they have very often approach.
00:19:56
Speaker
We used to use something like that.
00:19:59
Speaker
I've been doing it for 20 years.
00:20:01
Speaker
It was good.
00:20:03
Speaker
So I want to keep with that.
00:20:05
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.
00:20:18
Speaker
Yeah.
00:20:20
Speaker
So in your position as the CEO of CleanMark Global CRO, is there any ongoing technology development that you're particularly excited about?
AI's Impact on Clinical Studies
00:20:36
Speaker
Very shortly, AI, because this is something which everyone is excited.
00:20:41
Speaker
Of course, this is
00:20:42
Speaker
bit more at i think this i would say it's too much of the excitement right now but it will really
00:20:53
Speaker
maybe not revolutionized, but changed significantly how the studies are conducted because AI can be used in different areas.
00:21:01
Speaker
For me, the key will be the design and setup of the studies.
00:21:05
Speaker
So protocol design, project design, and the adaptive studies is something which is totally
00:21:14
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.
00:21:26
Speaker
This is something which also very much will help to get it.
00:21:31
Speaker
But even internally, we are now in the process.
00:21:34
Speaker
This is still the ongoing process of the internal development of the AI model, which aims
00:21:44
Speaker
to, for us as an organization to easily get access to know how, which we have.
00:21:52
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.
00:22:06
Speaker
So, so this is, I think it will take some time, probably half a year or something like that.
00:22:12
Speaker
But then if
00:22:14
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.
00:22:31
Speaker
So there are many things and AI Wesley use will really change totally the clinical research within next five, 10 years, I guess.
00:22:43
Speaker
Yeah.
00:22:43
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.
00:23:03
Speaker
Yes, and make quicker and shorten the decision path because we have data quicker.
00:23:11
Speaker
That's great because I've never heard anyone share this scenario of AI.
00:23:17
Speaker
Everyone's talking about accelerating patient recruitment.
00:23:20
Speaker
You mentioned accelerating setup, for example.
00:23:23
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.
00:23:37
Speaker
Yes, because that's the problem, I think, of every organization that
00:23:42
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.
00:23:51
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.
00:24:08
Speaker
and how to overcome and resolve the problems which has occurred during the studies, the execution.
00:24:17
Speaker
And there's so many information, but every time, you know, our database of the cases, of the solutions is bigger and bigger.
00:24:28
Speaker
And after years, you forget sometimes.
00:24:31
Speaker
And it's not so easy to come back and have everything in hand because
00:24:37
Speaker
Nowadays, I see there's so many information a day which we are pumped by
00:24:42
Speaker
not only the professional world, but also the private world.
00:24:45
Speaker
So the distance turnover is much more quicker.
00:24:48
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.
00:24:57
Speaker
So, and it was brilliant solution.
00:25:00
Speaker
So let's say propose it and copy that, or use that for another client, for another solution.
00:25:06
Speaker
This is something which will be valuable, but it will help not.
Educating Management on AI
00:25:11
Speaker
Have you started educating your teams in the use of AI and reskilling your teams?
00:25:21
Speaker
Yes, we started with the management.
00:25:24
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.
00:25:36
Speaker
So they know more and more.
00:25:37
Speaker
And there is one leader who is, she is actually dedicated to that and she's supporting me very strongly.
00:25:46
Speaker
Also in seeking for the implementation.
00:25:49
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.
00:26:10
Speaker
different type of limitations.
00:26:12
Speaker
So we are, as I said, in the process, this is not very long.
00:26:16
Speaker
I mean, because we started that so deeply since more or less February or March, but already have some ideas.
00:26:25
Speaker
And as I said, one already in process and other in the preparation for the implementation.
00:26:33
Speaker
Amazing.
00:26:34
Speaker
Amazing.
00:26:36
Speaker
I love your excitement and how you seem very hands on in innovation.
00:26:42
Speaker
That's great.
00:26:44
Speaker
I've got one last question for you today.
Embracing Change and Overcoming Failure
00:26:48
Speaker
What's the best piece of advice you've received in your career that you keep applying to your work?
00:26:59
Speaker
Good question.
00:27:00
Speaker
And you know, the answer could be so wide from the childhood.
00:27:04
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.
00:27:16
Speaker
So that's one thing which was very important.
00:27:20
Speaker
And my father said always to be consequent, believe in yourself, have your directions and try to realize.
00:27:27
Speaker
But if it fails,
00:27:30
Speaker
do not be worried.
00:27:32
Speaker
And he always said and always says, be brave.
00:27:36
Speaker
So just if you have an idea, just try to do that.
00:27:41
Speaker
So that's one thing.
00:27:43
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,
00:27:56
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.
00:28:13
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.
00:28:22
Speaker
Very many, most of the people
00:28:26
Speaker
are afraid.
00:28:27
Speaker
They would like to have constant life, but it is just impossible.
00:28:31
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
00:28:56
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.
00:29:06
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.
00:29:19
Speaker
Yeah, it's about what you can control and you can't control as well.
00:29:24
Speaker
But you're right, change is always going to be there, especially in our industry.
00:29:27
Speaker
So that's for sure.
00:29:29
Speaker
Yeah.
00:29:30
Speaker
I love what you said that your father taught you that if you fail, it doesn't matter.
00:29:38
Speaker
Because that risk of failure, if you're too worried about that, then that's where you don't take the risks, essentially.
00:29:47
Speaker
So it must be freeing to think like this.
00:29:51
Speaker
Yes.
Conclusion and Gratitude
00:29:53
Speaker
Well, Marek, thank you so much for your time.
00:29:55
Speaker
It's been wonderful.
00:29:57
Speaker
I love your energy and I'm sure your teams must really appreciate how you push them for innovation.
00:30:07
Speaker
That's amazing.
00:30:08
Speaker
Thank you so much.
00:30:09
Speaker
Thank you for an interesting interview and for nice words about myself.
00:30:18
Speaker
Well, my pleasure.
00:30:19
Speaker
And thank you everyone for watching us or listening to us today.
00:30:23
Speaker
You can find many more episodes of Clinical Data Talks on the CRS Cube website.