Bridging Borders: Enhancing Clinical Research in Europe

Clinical research in Europe presents unique challenges, from navigating country-specific regulations to addressing language barriers and patient travel logistics. Scout’s Moisha Platto and Courtney Dodge share how tailored solutions are enhancing clinical trial efficiency across Europe and what this means for sites, sponsors, and patients. Hear strategies for improving patient engagement, streamlining reimbursements, and ensuring compliance with regional regulations. 

Transcript

Jimmy Bechtel 0:01

Welcome to SCRS talks provided by the Society for Clinical Research Sites. Thank you for joining us as we explore the latest insights, trends, and innovations shaping clinical research today. I'm Jimmy Bechtel, the Vice President of Site Engagement with the Society, and today I'm joined with Moisha Platto, the CEO of Scout, and Courtney Dodge, who is the Vice President of Clinical Operations with Scout as well. Really excited to have both of you here with us and to talk a little bit about some of the work you guys are doing in the European market, specifically to help clinical research sites and how important that is, not only to your market, but also to SCRS and the great and upstanding sites that are over in that region of the world. So, before we jump in Moisha, I'd like to start with you and get a little bit more background and introduction from you.

Moisha Platto 0:49

Yeah, thanks Jimmy. Moisha Platto, CEO of Scouts. Been with the organization for about a year and a half now, and been in the world of clinical research and mainly at large CROs for well over 20 years. So very happy to be at. Scout as a small but very important player in delivering trials, engaging patients, and retaining patients through their visit cycles. So really excited to be here with you and talk about how specifically we're focused on Europe in our service offerings.

Jimmy Bechtel 1:19

Awesome. Thanks. Courtney same from you. We would love to learn a little bit more about you before we jump in.

Courtney Dodge 1:24

Sure. And thank you for hosting us. I'm Courtney Dodge. I too have about 20 plus years of experience in the industry in the biotech space CRO world. But I think most importantly on the site side, having that direct experience, working with sites, site networks, and really understanding what our sites are going through on a day-to-day basis and how Scout services best support those efforts for the coordinators, site directors and PIs ultimately being able to offer a service to their patients. So excited to tell you all the exciting things we have going on in Europe.

Jimmy Bechtel 1:59

That's great. I too am excited to learn more about what you all are doing. So thank you both. Moisha, I wanna start with you because I know that you recently spent time in Europe supporting your research sites that are engaged with you all in that region. So can you start us off by sharing some of the insights that you gained from that time that you spent with them?

Moisha Platto 2:20

Yeah, of course. It's the most important to note that the needs and challenges in Europe aren't any different than the rest of the world. And a lot of research and goes on in the US and Canada, North America. The difference is it's very acute. The nuances in terms of the different country regulations, cultural needs and expectations, and that's really where Europe differentiates itself from the rest of the world, specifically US and Canada. The needs, the burdens of the sites are the same, but to be able to work on a protocol with a sponsor throughout Europe really requires someone to have a depth and breadth of offering and be able to be flexible enough to cater to the specific data privacy rules that may be set up in a specific country and the different cultural needs and expectations of those countries. So a lot of the pharma sponsor clients that I talked to and met with were really focused on meeting their sites and their patients where they are locally, and being able to have service providers that can cater to those needs and desires and expectations throughout the region and the territory. Not just having someone who can do one thing in a given country and need a different vendor and service provider to do something else in another country, and therefore all the sites have multiple vendors that they have to deal with. But really be able to meet the sites and patients where they are and not have to ask them and force them to change how they're running their trial,change how they're living their life, if they're a participant. But be able to simplify all the different machinations of a clinical trial for those investigators, for those patients across the territory. A lot of the sponsors are realizing this and they have a, not necessarily new, but some are new, but are giving more voice to patient advocacy leads within their organizations to work directly with sites, directly with participants and liaise with service providers such as Scout to make sure we're meeting these sites and patients where they are.

Jimmy Bechtel 4:31

A lot of really great points there Moisha and that's similar to the conclusions that we've drawn as we deliver our content and work for the European audience. It was one of the first ones that we ventured into when we broadened the United States. And we learned that their challenges are similar, where we share universally across the globe, really a lot of the similar challenges universally. But I think you stated it really well when you talk about that each nuance exists in each country and with some of the EMAs,EU based regulations, GDPR, and things along those lines that we have to be sensitive to when we look at the global audience. But they are just as thirsty for clinical trial participation and being taken seriously in the ecosystem of clinical trials as sites are based in the US and North America broadly. It's a great point, but I do wanna dive into those unique challenges. You had mentioned that there are some unique things that are specific there. So can you expand on some of what you learned as far as again, unique challenges?

Moisha Platto 5:30

Of course. So, English is the quote unquote global language and most investigators and service providers communicate commonly in the English language. But that's not to say that for the investigators and especially for the participants, it's, not their core way of communicating or even that a lot of the participants don't speak English. So being able to meet them with bilingual patient liaisons is something we focused on a lot at Scout and we like to let the sites know that we have that capability, right? Whether they have a technological question about the portal or logging in as simple as that. All the way through helping participants and investigators navigate patients with travel, expense, reimbursements, cross border travel which gets very complicated and stressful and brings a lot of anxiety for investigators and our participants. So, being able to meet them with their local language needs is very helpful and beneficial and comforting to the investigators and especially the participants. Another big piece in just the logistics of running a global trial is many pharma companies and what we're learning is many big large site networks have country leads. And throughout the startup process folks are very focused on country regulations, country approvals, and startups, negotiating CTAs, et cetera. And what we're trying to make sure is that the sites and the investigators understand what tools and options are at their disposal on a given opportunity. So when Scout is involved, as an example, we want to make sure that investigators are aware that we're a service and a product that is available to them to pay stipends to their participants, manage the expense reimbursements for their participants, and even move their participants around and even across borders through different countries. Sometimes at a high level, sponsors and big CROs are aware of all the different vendors that are involved and we make a lot of assumptions about the investigators and what they know is available to them and often they're not made aware. They have multiple protocols that at any given time that have different services involved. They have maybe not participated in delivering a protocol in some time. It's important early on in the startup phase to work with investigators so they know what's available to them. We try to come to them with varying options, so it's not limited. Some countries predominantly like to use digital wallets to pay participants. Some are ACH deposits into their checking accounts. Some are still paper checks. We wanna make sure they understand that whether it's a prepaid debit card or a paper check, we can meet them and accommodate them with all of their needs so they understand that going in. So when they're talking to potential participants in the screening phase, they can incentivize and make it more attractive for these participants to get involved knowing what all of their options are.

Jimmy Bechtel 8:25

Moisha great points. What I really hone in on and what I really appreciate is not only the awareness of one of the points that you made very early on, is this concept of these language barriers and we tend to perpetuate research in English first universally. Kind of across the globe in a lot of different ways. And that presents its own set of challenges, not only for the sites, as you can imagine, but also as you pointed out, for the patients, most importantly, that are coming in the clinical trial that these sites are trying to communicate with. So we're kind of almost playing this like telephone in a lot of instances where we're trying to translate, and it's coming from us at the high level down to the site and then down to the patients and, hoping that none of that gets lost and that we're really articulating the points we make and most importantly, that the patients truly absorb and understand what they're getting into when they choose to be part of a clinical trial. And it's awesome to hear that Scout is aware of this and perpetuating the use of effective methods and tools to be able to enable patients and sites to kind of go through the recruitment and and initiation process effectively. It's really important when we talk about opening and expanding the.eye of research and the accessibility of clinical trials across, across the globe, and as you so acutely and, keenly pointed out, that variation exists so highly in Europe, way more so arguably than it does in North America or the United States. So, Courtney, I wanna shift over to you now and talk a little bit about specific services now that Moisha has done such a great job to help us set the frame and paint the picture for how things are going over in Europe. So can you dive in a little bit to how Scout tailors its services around these items to reduce that patient and staff burden and really help and improve some of the trial retention outcomes. I guess, in other words, how is Scout kind of specifically addressing some of the challenges that Moisha has brought forward?

Courtney Dodge 10:24

Absolutely. So what we've been able to do as an organization is, I'll echo one thing that that Moisha mentioned is there are many sites in and throughout Europe who simply don't fully understand some of Scout's service offering. So it's establishing the trust and once we've established the trust in Italy, in Spain, in Germany, in France of what the service offering is, that certainly sets the foundation. But those four countries that I just mentioned have their own unique approach to how we reimburse and pay participants in those areas as well as how we're making sure that as Moisha mentioned, cross border enrollment. We are moving patients around country to country on a daily basis, ensuring that they have access to treatment. So unlike here in the US where we can easily get someone from Chicago to Houston to participate in a study. In other parts of the world, it's can be a little bit more challenging and a little bit more of a burden to the patient and the site. So helping to ensure that we are clearly communicating to the site, the service offering, and that we understand the nuance in that specific country and have met all the regulatory needs to accommodate that site and therefore their patients has really been a huge stepping stone for us to establish that trust globally. In France that's a manual reimbursement piece. I'll speak to that one specifically. We have been able to really solidly establish the process for that. Having local individuals be able to speak French, to understand what the sites are needing, what the patients are needing, accommodate things in the local language, and then being able to process that manual reimbursement form and getting those participants paid quickly is really a key to gaining the site's trust in that area. In Spain, it brings its own unique challenges in how we address sites and patients in Spain, and we've been able to meet those patients where they are, as Moisha mentioned. Every regulation, everything that needs to be accommodated Scout has found the way to do that. So broader picture, ensuring that just because there are challenges or specific regulations in these areas, we've been able to overcome all of that to ensure that those patients are getting to sites and receiving the treatment that they so desperately want. To your point, Jimmy, earlier. Europe is so full of energy and enthusiasm to be able to offer studies to their patients, and then it's kind of one hurdle after the other, right? Identifying the country, identifying the site, and now trying to identify those patients and they're not always in your backyard. Being able to identify the challenges and then bring the patients to the sites where they can really engage and participate in a study that will hopefully, potentially save their lives.

Jimmy Bechtel 13:31

That's a great series of points. Courtney and I really resonate with the recognition that each country how they reimburse and pay patients can be so unique and so different and what we're able to do based on regulations and best practices, cultural norms and things like that. It varies considerably and we want to be able to reach each one of these countries and their unique patient populations for our clinical trial. So looking at those kinds of things is really important and being able to provide through platforms like Scout, the appropriate avenues and the understanding and the navigation, is really what it boils down to for the sites and for the patients and being able to help guide them through that process and, and what that really means for them as they participate there and facilitating a smooth process, but being nimble enough to provide effective service for the sites and for the patients in those unique situations is I imagine like you have both alluded to a challenge, but one that it sounds like Scout has risen to, which is great. So I wanna begin to wrap us up here with our final question and this one will be for you Courtney, and again Moisha, if you have any additional thoughts on this one, please. How does Scout then tailor its services to support sites and sponsors with navigating the regulatory landscape and logistical requirements. We talked about reducing staff and patient burdens, but let's take it up a level and talk about the services around navigating the unique and, oftentimes disparate regulatory landscape in some of those logistical requirements.

Courtney Dodge 15:03

Absolutely. Where I'd like to start is from that sponsor's perspective, when the sponsor's developing the protocol and deciding where this ideal landscape for enrollment and recruitment will be. Where we find that we are most successful is twofold, being able to work with the sponsor, determining what are our best options for being able to accommodate a patient's needs in that particular region? Being able to look at a protocol review, what the country landscape is, makes suggestions on how they can best meet the patient's needs for travel, for reimbursement, for stipend payments, whatever that may be early on, really helps lead to more execution throughout the course and the lifecycle of that study. In turn, we're helping the site by equipping the sponsor with the adequate information to empower the site to be able to support their patient. Starting early on with the review of that protocol and then helping initiate all of those services throughout the life of the study with the site really enables the site to be able to offer the very best options to their patients. So doing that by region, as you mentioned earlier, every country has its nuance. So every country has a regulation that is going to be tailored for whatever is best for that particular situation. And Scout has been able to do that so early on being involved with the sponsor so that we're ensuring that all of these considerations are made. So once the site has that in front of them, they know, they're able to offer a fair reimbursement compensation that will help ensure that the patient is not burdened by the participation in the study. Those are all challenges that we've been able to face and overcome with our fantastic regulatory team that is always well versed in the country landscape and every regulation we may possibly face, ensuring that we're meeting the needs of our sponsors, the sites, the patients, no matter where they are. Operating in over a hundred countries has really given us the expertise and the experience to kind of replicate this model. Knowing what we need to do, where, in order to meet the needs of those patients, sites,and ultimately our sponsors.

Jimmy Bechtel 17:36

I think that's a great place to end our conversation, Courtney. And it's this concept of help us help you, right? Let's work together in this sponsors and sites, we wanna help you work more effectively with your sponsor and CRO partners. Let's work together in this triangle to really drive things forward for patients in these countries and work through the nuance, work through the challenge, address it and make sure that we can come away with what we need to in order to effectively deliver that clinical trial. That's a great sentiment for us to end things on. Moisha. Courtney, thank you so much for your time today and for providing some insights into not only what Scout's doing, but also some of the unique landscape that exists in Europe. And what kinds of things we should be thinking about as a community to address some of those challenges and maybe some outta the box or just solutions to be able to do that. Moisha, thank you for being here with us and for sharing your insights.

Moisha Platto 18:34

Thank you, Jimmy. We really appreciate it. Appreciate the time and we look forward to working with you and the SCRS community in the days, weeks, and months to come.

Jimmy Bechtel 18:42

Courtney, same to you. Thank you so much.

Courtney Dodge 18:44

Thank you so much, Jimmy. It's always a pleasure. And thank you SCRS team for all of your efforts. I know that you speak loudly on behalf of the sites and it's so much appreciated.

Jimmy Bechtel 18:54

Absolutely. Well I hope that our listeners can come away with some new learnings and perspectives to advance some of the work that they're doing, particularly our European audience. I'd also like to add that for everyone listening, make sure that you don't forget to explore other site focused resources that are made available to the entire community on our website, my scrs.org. It also includes opportunities like our site solutions summits, other podcasts, publications, and webcasts made available throughout the year. Thanks again for listening and tuning in, and until next time.