رونوشت کامل Building Better Clinical Tech for CRAs with Anna-Liisa Parts

clinical lead and I saw that ⁓ was not the only one struggling and I was not really the only one who had the problems. And as I knew, because I was working for IQVIA, IQVIA is a big corporate and when I joined IQVIA, I was just at the time when ⁓ merged together with the IMS. So it was basically doubling in size. It was at the time, I think even 80,000 people that had ⁓ there. And I knew already that if I tried to do it internally, for example, or to maybe ⁓ find a way to build something internally, it will take a lot of time and even to get, I think, somebody on board there that would be quite a lot of time. ⁓ ⁓ fortunately had the luck to go to my brother, who is another co-founder, ⁓ ask if even these kind of things that I'm thinking of, are they even possible? Because I didn't have any technical background myself. ⁓ we brainstormed. He also invited ⁓ of our old schoolmates, which is the third co-founder. ⁓ was the start of it. So we just saw that it's easier to do ⁓ basically separately from or as a company itself than to try to do it internally, for example, me or and some of colleagues that I used to work with in IQVIA. ⁓ So it definitely, I would that was the trigger for me start the ⁓ company that we now have. Theodora Savlovschi-Wicks: Mm. How fortunate though to be able to do that with your brother. Blessing or a curse? Anna-Liisa: Yeah, definitely. It was really nice. Yeah, but I think we have had always a relationship where we have collaborated really well in a sense that and we are have been like, of course, brought up the same way that way. We want to do always like I wanted to build companies because our dad had his own company that he built from the start and we have same tribe so it was a little bit easier ⁓ start with. Theodora Savlovschi-Wicks: Yeah. That's amazing. So entrepreneurship is something that runs in the family then you always knew ⁓ day you will build something of your own. Anna-Liisa: Yeah. Yeah, that was the hope. Yeah, definitely. Theodora Savlovschi-Wicks: Okay, and can you tell us a little bit more, what is Menken Trials trying to solve? What is the issue that the company addresses? Anna-Liisa: Yeah, so our like full focus is currently on essential documents. So document management, eTMF and eISF. And we are doing differently is that we actually, because we know that documents and ⁓ document management itself is really undervalued ⁓ trials. We know that CRAs usually might not even get to do the reviews because of the lack of time that they have or the DMF manager will take months to three months to review documents and so on. We wanted to do it a little bit differently and have the system automatically actually check not only if the, I don't know, metadata is correct or the file location is correct, but also the content that actually is within the document. So all of the basically if the CVs are up to date or the CVs signed, if the delegation and the CVs actually match and so on. So basically, all of the work that usually is done or the checks are done by CRAs. Now we have embedded them into the platform. So basically like a virtual CRA, I would call that, who is doing the initial check. Because the reason why we see, like it also, as I mentioned already, it came from my own experience. Theodora Savlovschi-Wicks: Mm-hmm. Mm-hmm. Anna-Liisa: But when the sites, for example, get the right away the feedback that something is incorrectly done or needs to be corrected, then they are more willing to do it right away than rather than three months after they have uploaded that. we have seen a really big shift in completion or like we call them compliance. So, sites are indeed more eager and willing and compliant if you like guide them through it and give them feedback right away. Theodora Savlovschi-Wicks: Mm-hmm. right. Mm-hmm. Anna-Liisa: That's what we're trying to do just to ease the responsibility or the workload that the CRAs have via just having the AI and automation on the platform as well. Theodora Savlovschi-Wicks: Okay, so it relieves quite a lot of the administrative burden from them then. Anna-Liisa: Yes, so just trying to I always have at the back of my head just thinking about how we can successfully go past inspection and because that's always like what the CRAs are thinking about ⁓ and if we are to help them to identify problems or shortcomings right away it I think gives like also the satisfaction. ⁓ Theodora Savlovschi-Wicks: Mm-hmm. Anna-Liisa: back to CRAs and the ease of mind for the CRAs. So, just to try to help them a little bit. Theodora Savlovschi-Wicks: Absolutely. Now everything that you've said so far obviously proves that you've made the switch from the industry and you know what the pain points are firsthand, therefore you've obviously built technology to address the pains that you yourself have had. Do you think that improves that type of mentality and that type of experience that you have improves adoption rates within technology? Anna-Liisa: So adoption rate, would say it definitely, maybe an adoption, it will go under adoption rate definitely, but I would say even the willingness to use, because usually if we're saying that the TMF is in a study, then it's decided by the CRO or the sponsor, who most probably will use it a little bit less. But still for the study teams, it's important that the site and also the, for example, the CRAs are actually working with this ⁓ and upload documents or fill in logs and forms. ⁓ And that that we have seen. So I think it's like helping in a sense to ⁓ complete the or helps to get the study completed. So that's definitely, ⁓ I would Theodora Savlovschi-Wicks: Yeah. Anna-Liisa: that. But ⁓ you mentioned that ⁓ having the experience as a CRA and using that to implement into also the features in the platform. ⁓ Like ⁓ experience just the soul of ⁓ millions of people around the world doing the same job. ⁓ But what indeed have done is ⁓ we have the feedback end users. Theodora Savlovschi-Wicks:

Mmm. Anna-Liisa: We are not building in a sense the platform for sponsors or the project managers from the CRO or the CFO from the CRO, but actually the end users. So that we have ⁓ we continue to do ⁓ because I think that's the core to get ⁓ people speaking about your platform. ⁓ if they like to use it, if it's simple, intuitive, then ⁓ you don't see ⁓ bad Theodora Savlovschi-Wicks: Mm-hmm. Anna-Liisa: word ⁓ out there that happen if you focus on another group of people. Theodora Savlovschi-Wicks: That's really interesting and I think we are as an industry overall perhaps with so much tech being built at the moment, right? It is a very noisy and crowded market space and I think I speak to a lot of people on a daily basis, both candidates and clients who talk about technology that is by tech people that isn't necessarily built by industry people and therefore there is quite a big gap between where the issue really is and what is being built for it. Anna-Liisa: Mm-hmm. Theodora Savlovschi-Wicks: I think you know obviously what you've done is quite unique in that sense. Anna-Liisa: Yeah. Yeah, definitely. Like us, it's also a struggle in a sense that ⁓ just had yesterday a person coming up to us who is not like fully from industry, but works with academics, trials and studies. And he just had gone to conference and saying that. ⁓ another company is doing the same thing as you. And I was like, okay, like what's company. ⁓ And ⁓ of the was some Theodora Savlovschi-Wicks: ⁓ Mm-hmm. Anna-Liisa: doing something different, because the person was not fully from the industry. And then I had a look into the background of the company, who is the founder and what they're doing. And basically the person who is the CEO was formerly owner of company who did Google ads. And I was like, Oh, totally different, no experience in the industry. Now saying that they have built a Theodora Savlovschi-Wicks: Yeah. Right, okay, it's very different. Anna-Liisa: like as the basis EDC, TMF, CTMS, like all of these tools. I was like, okay, again, like it's also difficult for us because they are ⁓ as competitors or doing same thing. But it's different if you don't have the background because you don't actually well understand ⁓ what the shortcomings or the gaps or the needs for these people. So, and even if you speak with them, it's difficult to exactly understand what they mean. they mean by some phrases or some things what they are saying. So ⁓ it's definitely a difficult thing for us, not only for the end users. But yeah, it's not ⁓ really the COVID and all of the boom, definitely there was lot of companies coming up with zero background in click corporation or even in the industry, I would say even. Theodora Savlovschi-Wicks: really understand. There's a lot of composition, I believe obviously speaking the same language as your end user is incredibly useful and is a huge USP because you're not another tech company. You're a purposefully built clinical operation medtech organization, right? And you've got a purpose and you started with that purpose and that insider knowledge that not a lot of people who have built tech actually have. Anna-Liisa: Yeah. Yeah. Theodora Savlovschi-Wicks: And I think perhaps there is a little bit more of a shift in the industry now where I've seen a lot more product being built with the voice of the consumer in mind and with the voice of the consumer, the end user actually woven through the product development process. Anna-Liisa: Mm-hmm. Mm-hmm. Yeah, and that should be that. If somebody decides to build something in industry, that should be the first thought of them. Like, how can I incorporate the people who actually will be using that? That's definitely, I think that if somebody wants to build something, definitely should take that into account. Theodora Savlovschi-Wicks: What was it, so obviously Menken is now starting to get very well established and it's becoming better known. Throughout your journey so far, what lessons have you learned from building a medtech in this community? Have we got enough time? Anna-Liisa: Indeed. ⁓ If somebody like, ⁓ I'm thinking about that. And as the same example ⁓ that new company that I was just ⁓ speaking from the Google Ads background, I was just poor him. He's still at beginning ⁓ the journey. Theodora Savlovschi-Wicks: He doesn't know what he's got himself into. Anna-Liisa: It's definitely like the only thing that I'm always saying it even if the Menken trials doesn't work out I have learned so much so much that I couldn't never have learned in any kind of company working for somebody like Elson and and they're in a role ⁓ definitely what I'm really thankful for ⁓ ⁓ additional say if you want to build in this industry, especially from the tech side or even I think as a CEO, maybe somebody wants to just build a CEO and start, you need to have the patience. Like this industry is extremely slow and there been studies that if you average, for example, it will take three years to get to product market fit, meaning you have the customers and you are generating revenue, then in health tech, will six So you need to have like the patience, the thick skin and that kind of thing. So definitely it's not an easy, easy thing to do, but definitely you will learn a lot. Really, a lot ⁓ about about the different activities that I've never like ⁓ marketing has been like so further away me. And now I'm like ⁓ posting three a week in LinkedIn recording some like as podcasts and everything else. ⁓ like, I have learned so much. So definitely it's interesting and do and to learn. Theodora Savlovschi-Wicks: Yeah? Do you think as an entrepreneur you have to build on these social selling skills, I guess, that everybody's kind of talking around? Anna-Liisa: Yes, especially in our industry. Basically, you as a company or a person, you will be more accepted if have heard about you or if they know about you. So definitely like this kind of marketing. I think it's not

only applicable in our industry, but it ⁓ definitely a difference. So we also didn't do much of marketing until I think last year, August or something like that, when we started to do and definitely there was a shift of people feeling, I think more comfortable in a sense that they already knew, know of us and maybe some people like follow already me or my co-founder who is also active in posting of struggles in the industry, but from a tech perspective ⁓ definitely it's a, I think it's a ⁓ thing. Theodora Savlovschi-Wicks: Mm-hmm. Mm-hmm. Mm-hmm. No, it's true. I think, you we've got similar experiences with that. It's ⁓ if you're not visible, you're invisible, right? Which is, the main messaging at the moment, I guess. ⁓ when you say, ⁓ were saying earlier that obviously, you include the end users within the tech build, is that CRAs primarily are you building mainly for CRAs and the clean ops teams? Anna-Liisa: Yeah Yeah, yeah. And... Yes, basically it depends really on the tool, because ⁓ do not only have the eISF eTMF, but we also have some other tools. But basically, it means totally the actual use of the platform, not like CFOs or people who never come to the platform. that we ⁓ include CRAs clinical leads, site staff, so basically all different parties that are using the platform. So definitely everybody is included and will be continuously included as well. Theodora Savlovschi-Wicks: Okay, so when it comes to technology in itself, I think pretty much every conference I go to, obviously we hear of more different tools, more AI integration, and just in general, I guess that the clinical tech space is quite crowded, right? And there are so many different so many different platforms that don't necessarily talk to each other. Anna-Liisa: Mm-hmm. Theodora Savlovschi-Wicks: where would you say men can trials sit in that ecosystem and how do you think about the overall integration problem? How do we ease that burden of and a huge amount of systems? Anna-Liisa: Yeah, ⁓ would say even that it's so like cited the sense that ⁓ we have who are not buying the solution from one vendor. Even like if we think about metadata, for example, ⁓ most like existing company providing tools in the industry ⁓ has all the solutions actually available. And just yesterday, we just spoke about with Maria again in our podcast that she was using Medidata's IVRS and I never had even heard of that, that somebody is using. And really comes down to the sponsors not selecting the same providers for the tools. And I think until, of I'm really 100 % sure as well what is behind that, like why is indeed even metadata size companies that other tools not so good that they are not able to buy them or there's something else in the background, until sponsors will not agree to the same vendor for the tools, it's also a difficult side. But if we even think about the ⁓ vendors and say, let's say that indeed the sponsor will take from five different vendors, different solutions. Also the willingness of between these providers to integrate with each other is as well limited. I think it's, I know there was a movement, I think it was now three or four years ago that a person actually I don't remember actually anymore who that was, but basically that should be more ⁓ willingness to integrate into each other and not like block or the data flow from one solution to another. I haven't heard about it anymore. It was quite like big at the time, ⁓ it still like comes down to so many like different sides where this is actually stopping. ⁓ And be honest, I don't have an answer to this question because I don't know how to resolve it ⁓ ourselves. Theodora Savlovschi-Wicks: Mm-hmm. Anna-Liisa: how would the perfect world look like in a sense how we could actually integrate. So ⁓ a difficult question and I think that's actually that's the reason as well why it has not been ⁓ to this day. ⁓ yeah, interesting to see it as well like where it will go. Theodora Savlovschi-Wicks: Yeah, think there's a lot of conversation around the fact, obviously, with the rise of ⁓ also the rise of different coding, ⁓ AI technologies. Recently, software become of a cheaper commodity than before. Right. So there's even more technology kind of flooding the market. It's a very crowded space, but you also have a lot existing platforms that don't communicate with each other. And ⁓ it's a big point of conversation a lot the time. Right. Anna-Liisa: Mm-hmm. Mm-hmm. Yeah. Yeah. Yeah, definitely. Theodora Savlovschi-Wicks: So what is next on the agenda for Mencken trials? What is your plan for the next two, three years? Anna-Liisa: Yeah, actually like aim is still to continue helping, like we are currently on the essential document side, ⁓ but we still to continue to find ways to help CRAs, because have been CRA, I have seen the struggles and I think I have spoken quite a lot about how CRAs are a sense alone. Nobody cares about. Okay, nobody is maybe too strong a word, but people do not really care about if they are struggling, if they are burnt out, if they have too much to do, if they have a backlog. Everybody's basically like, why haven't you done this? You need to do it. Like the negative world is really strong there. So we definitely want to continue to try to find ways how we can help to automate the work Theodora Savlovschi-Wicks: you Anna-Liisa: of a CRA and I really mean like in a core core level like what I used to do which was really repetitive, really like time consuming, this kind of like activities hopefully in the future I have found a way ⁓ we have found a way to do that and can actually help the CRAs to what I love to say and what I really like ⁓ valued at time when I was a CRA is ⁓ Theodora Savlovschi-Wicks: Mm-hmm. Anna-Liisa: We had time for, I don't even know how, but for some reason we had time when we sat down with the sites and had coffee, had cake, had like this kind of like personal connections with the sites. And I would really love to bring that

back and not have this like 15 minutes and quickly get everything done, but actually have this good collaboration and the possibility to actually build the collaboration CRA's because they now have the time to Theodora Savlovschi-Wicks: Hmm. Anna-Liisa: spend time with the sites. Theodora Savlovschi-Wicks: Do you think it's only the CRA position that promotes a culture of burnout or clinical operations overall? Anna-Liisa: So I think that's definitely ⁓ I have been in the also the clinical like clinical like management team. Definitely there is burnout. I will not say that there is no burnout. That's that's definitely true. ⁓ But ⁓ my experience, clinically it was way easier ⁓ than being CRA ⁓ because you like basically an orchestrator. You just like followed up the CRAs and try to understand where somebody was at the time and what they need to do. But that's a CRA like all of the responsibility, it's like the responsibility that relies are on your shoulder because you are responsible in a sense for patients. You are responsible for ensuring that the sites get the study done correctly and no problems with that. I think that the emotional struggle is bigger there than, of course, I'm not Theodora Savlovschi-Wicks: you Anna-Liisa: like saying that there is no problems in clinical management teams ⁓ definitely I would say I think that we definitely are as well interested in a sense that we know that as have done the work, there's a of ⁓ things to as well. ⁓ But yeah, as I'm passionate about the CRA, then we start there and I try to find the ⁓ ways to them first. Definitely, click-reoperation itself is really interesting and there is a lot of things that can be done ⁓ with the solutions that are available for people. Theodora Savlovschi-Wicks: So ultimately also automating to allow more the human interaction, right? Anna-Liisa: Yeah, definitely. And even just the possibility to have the administrative ⁓ that takes so much time to be taken away because ⁓ quite often as well that if have the overload, you most probably will make in the sense that you forget something or you just quickly try to get done and you have a ⁓ limited oversight. But indeed, to just Theodora Savlovschi-Wicks: Mmm. Anna-Liisa: help the possibility to have the time to communicate and to have maybe more of a friendship between the CRA teams and the clinical operation management team as well. Theodora Savlovschi-Wicks: Mm-hmm. If you were to do it all over again and to start from scratch, would you still start in a CRA position? Anna-Liisa: Yes, in a heartbeat. Like, CRA position for me was the most amazing part. I would still I'm always joking with my previous boss or manager from IQVIA that would love to do a CRA work again if I have really good sight and I don't have the negative communication and I would really like to do it again. it the things that you learn and the value that you learn from that position is extremely big. You see and you understand so much ⁓ a lot of people

might never understand even though they're in the industry. Yeah, definitely. Theodora Savlovschi-Wicks: I speak to a lot of entry level individuals who are looking at breaking into the industry for the first time, what advice would you give them? Just kind of be prepared, what's coming for them? Anna-Liisa: Yeah. Yes, even regarding I think the most and we have spoken about this as well in our podcast. The most like what I felt when I graduated is that I felt that the world is open for me, like everybody will have me and actually like invite me to work for them. Of course, reality is totally different. I would say for a graduate who actually wants to get into them Theodora Savlovschi-Wicks: Mm-hmm. Anna-Liisa: drug development industry, need to start networking before you graduate. You really need to get to know people from the company. Most probably they, of course, will move around. They will not stay, even if you meet somebody from IQVIA, most probably they will not be at IQVIA when you graduate and want to go in the industry. But they be in another company that also might be recruiting. ⁓ And the why I'm saying why you need to network is because Today's economy and industry, the way it is currently, it's extremely difficult to get in from, without a referral. So if you know people and you get a really connection, then definitely use that to tell them that ⁓ I'm really interested in this position. Can you maybe ⁓ contact your HR and see it's actually open or if it's something that I ⁓ additionally provide to this person just to show how interested I am. So this kind like Theodora Savlovschi-Wicks: Mm-hmm. Anna-Liisa: this kind of proactive and definitely networking is the core. Even if you are not graduating but you just want to get into the industry, same thing. Theodora Savlovschi-Wicks: active approach. Anna-Liisa: it's really difficult to get into the industry and it will take a lot of time. So definitely try to network and once you are in the position as a CRA, for example then just observe, take everything in. It's really interesting. It's a lot, definitely the first, I would say, few you will be overwhelmed because there is so much information coming in, ⁓ it's also interesting and it's really like valuable that you will learn there from. So definitely just be open, ask questions, ⁓ to maybe shadow, even not only for the CRAs but if you have clinical lead that you just maybe can shadow and understand what they are doing so definitely try to use this kind of opportunities. Theodora Savlovschi-Wicks: you so much. This has been ⁓ fantastic and it's been really interesting to kind of hear a little bit more of your journey. So where can our audience find you, if they'd like to have a conversation? Where are you going next? Anna-Liisa: Yeah, always everybody can reach out to me via LinkedIn. I'm always like I have no rejections any kind of connection requests because I always like to as well broaden my network. ⁓ Definitely you write to me there but also the conferences that are coming up. So perfect one is course coming up as a CRACONNECT LIVE which is happening in Barcelona. And definitely if CRA is currently listening to this or even clinical operations people, then definitely recommend to go there. It's really, before we started the broadcast as well, we were saying that it's really an intimate ⁓ like operation conference coming and really usually you will only see the BD people coming there and trying to sell their products, but it's actually over a long time where clinical operation team is coming together and actually sharing their experience and their knowledge. So that's, think it's extremely valuable. Theodora Savlovschi-Wicks: I'm really looking forward to meeting in person as well and I'm really looking forward to just speaking to over 200 CRAs in person as well. That'll be fantastic. In a sunny place like Barcelona as well. Anna-Liisa: Yeah, he did. Yeah, indeed, Yeah, indeed. Yeah, thank you as well. Really, really awesome to have been here. Theodora Savlovschi-Wicks: Thank you so much, Anna-Liisa.