Keeping clinical trial patients enrolled: real stories of high-touch support

Ryan Muise — Host, Xtalks
Well, good day to everyone joining us, and welcome to today's Xtalks webinar. Today's talk is entitled Keeping Clinical Trial Patients Enrolled: Real Stories of High-Touch Support. My name is Ryan Muise, and I'll be your Xtalks host for today. Today's webinar will run for approximately sixty minutes, and this presentation includes a Q&A session with our speakers. Now the webinar is designed to be interactive, and webinars work best when you're involved. So please feel free to submit your questions and comments for our speakers using the questions chat box, and we'll try to attend to your questions during the Q&A session. This chat box is also available for sending any questions you may have regarding some technical difficulties. You can reach me there, and I'll respond to you, during the webinar. I'd also like to welcome, of course, our attendees who are viewing this presentation from our LinkedIn Live event, and I encourage you to submit your questions as well via the comments tab. At this time, I know that all participants are in listen-only mode, and please note that the event will be recorded and made available for streaming to those who have registered on xtalks.com. At this point, I'd like to thank Suvoda who developed the content for this presentation. Suvoda is a global clinical trial technology company with a market-leading real-time software platform that empowers sponsors and CROs to make confident decisions and sites and patients to take calm, controlled action. Suvoda delivers interconnected action-driven software solutions and industry-leading services and support so that even in the most time-sensitive, mission-critical moments, life changing studies keep moving forward. Now I would like to introduce our speakers for today's event. As a senior study startup lead within Suvoda's financial and travel business unit, Carolyn delivers a study implementation for clients specializing in concierge and France-specific support. She works directly with sponsors and CROs on study startup to determine the best path forward for participants through optimal study configurations. As a global study manager within Suvoda's concierge team, Kyle oversees the delivery of concierge travel, budget management, and patient payment, and reimbursement services for clinical trial sponsors and CROs. He works directly with sponsors and CROs to ensure study configurations run smoothly and efficiently, supporting participants and families throughout the trial journey. As concierge coordinator at Suvoda, Beatriz coordinates travel and logistics for patients and caregivers participating in clinical trials across Portugal, Brazil, and the United States. Since joining Suvoda in 2017, she has worked closely with participants, study sites, sponsors, and clinical research teams to support every stage of the travel experience from patient onboarding and visa coordination to booking flights, hotels, and more. And as a concierge coordinator at Suvoda, Igor works directly with clinical trial sites and participants to provide personalized and tailored support throughout their trial journey. He is based in Poland and works with participants across a wide age range, from infants and young adults as little as six months old to people well into their eighties. But now without further ado, I'd like to go ahead and hand the mic over to our moderator for today's discussion. Carolyn Mullen, you may begin when you're ready.

Carolyn Mullen — Senior Study Start-up Lead, Suvoda
Thank you, Ryan, and hello, everyone. Thank you again, Ryan, for all of our introductions, and thank you all just for joining us today as we really talk about our concierge support and patient centricity. So we really wanna talk and start with that idea of patient centricity. Truthfully, when we think about it, we also have to think about participant burden. When we talk with participants, every study we see, they're really giving their time, they're traveling, they're rearranging their work lives, their family lives, and there's a lot of costs that can come up along the way as well. When that burden gets too heavy, that sometimes can lead to people declining to enroll in the trials or could even cause them to drop out once they have enrolled. So we really wanna talk and focus on patient centricity and how that really comes along with participant burden. So when we think about travel and financial hurdles, those consistently come up from participants as those top barriers to being involved within trials. Participants have even told us that when it comes to what those disruptors look like when looking to enroll in a trial, a lot of them are showcasing it's travel, it's reimbursement. So we really try to look at that at Suvoda and think how can we best support that. We also know that a high level of participants, 57%, say that those potential out-of-pocket expenses can really be a lot to incur and something that, again, prohibits them from getting involved, so we really look at how we can support that. So it's all about getting the participants to the site, understanding what that financial picture looks like, and just really looking at the participant and not just at the trial. So that's where it really comes involved with patient centricity. So at Suvoda, we really wanna meet patients where they are, support what their unique needs are, and really work with them to give them the best experience. So, of course, with Suvoda, we have so many different models and so many different ways we can support our clients and our participants. But we know sometimes that certain models, certain standard models work well for certain trials and others not as much. And that's really where we wanna work on today to really introduce the concierge model and how we support participants through our concierge support. So I know during our introductions, you heard some of our roles briefly. So I myself am a study startup lead. So that means I work directly with our clients to really develop what a trial is going to look like from the participant support perspective. With my team of concierge team members, we also have our global study managers and our concierge coordinators that we work closely with. So today, thankfully, we're joined by several of those team members. So I wanna first start with Kyle. Kyle, again, is one of our global study managers. So, Kyle, I'd love if you could start just with an overview of what your role is as a global study manager or GSM and just an overview of what concierge support looks like to our team.

Kyle Renick — Global Study Manager, Suvoda
Well, thank you very much, Carolyn. And, again, my name is Kyle, and I'm a global study manager. Essentially, I am the main point of contact for these sponsors and the CROs throughout our partnership in the trial. So if they have any questions about what we can offer, if we need to expand our services, execute change orders, monitor budgets, all of that, goes through me. But I also have the privilege of working directly with our team of concierge coordinators who are located in countries all around the world. And so together with them, I also work to support site and participant requests. A big part of my role is onboardings. That's a term we use a lot at Suvoda, onboarding, and you may hear that word again and again today. But, essentially, onboarding just means introducing our services to the relevant parties. And the first group of people that I onboard are our concierge coordinators. I will first learn what the study protocol is, and then I will work with each of our concierge coordinators to review that protocol and make sure that we understand the nuances of the study. And once the coordinators and I are both onboarded to the study protocol, then the next groups of people that I work with are the CRAs who often receive the most questions from clinical sites. I wanna make sure that the CRAs understand what our services are so that they know how to funnel questions to us. If the site coordinators end up with any stray receipts, they'll know that they can send those straight to us. And then the last group that I onboard are the clinical sites themselves. At that time I will also introduce the concierge coordinator who is assigned to their clinical site to that site's team. I conduct all my trainings in English. So if ever a clinical site would prefer to have the training done in their local language, then our concierge coordinators are also available to facilitate that onboarding call. But I think the main question is what is concierge? So circling back to that, concierge essentially means connectedness. It means ensuring that participants don't feel alone in their clinical trial experience. And the way that we ensure that is by connecting them to a point of one on one contact who is our concierge coordinator. So our concierge coordinators, they are experts in bridging that gap between clinical exactness and adding human touch back into the trial. We know that clinical trials, by their very nature, are clinical experiences. They're focused on data and results and privacy. And so our coordinators, again, they know how to maintain privacy and protect PII and PHI, but they're also talking directly with the families and with the participant themselves. And so they are there to be that human touch that ensures that if participants ever have any questions about travel, reimbursement, expenses, or really anything else, they can always contact our concierge coordinators and have someone there to help them.

Carolyn Mullen — Senior Study Start-up Lead, Suvoda
Thank you for that, Kyle. Thank you for that. Just overview and outline of our concierge support and, of course, the introduction of our concierge coordinators. So as of now, we have 75 coordinators across 29 countries. So this is huge because having all of these coordinators who can support all of our participants, again, in that local language support, in that local time zone support, and bringing those resources for our participants and our sites is just a huge benefit. Right now, our coordinators are providing support to over 8,500 participants across 3,200 sites. And we are very fortunate because on today's webinar we have two of those concierge coordinators with us to really share what their experiences are as a coordinator on our concierge team. So, Beatriz, we're gonna start with you if you don't mind. If you could first share with us what region you're in and, again, what areas you support.

Beatriz Oliveira — Concierge Coordinator, Suvoda
Hello, everyone. I'm happy to be here today. So my name is Beatriz Oliveira, and I'm a concierge coordinator based in Brazil. And I've been supporting clinical trial participants for nine years now in Brazil, Portugal, and the United States. I currently support approximately 300 participants across a variety of therapeutic areas, including oncology, pediatrics, Alzheimer's disease, and neurological disorders. Today, I'd like to share a personal experience that highlights the impact we can have on participants and their families beyond the logistics of travel and reimbursements.

Carolyn Mullen — Senior Study Start-up Lead, Suvoda
Thank you for that. And, gosh, 300 participants. So I'm so thrilled you're here to share those stories with us. And so I'd love for you to jump into that experience you'd like to share that really showcases that concierge support of our participants.

Beatriz Oliveira — Concierge Coordinator, Suvoda
Thank you, Carolyn. So, today, I'm gonna tell a story about a family from Brazil. They are from the Northeast of Brazil, which the weather is very hot. They are four family members. The participant was a child with a rare and heightened condition, and she was participating in two clinical trials simultaneously in the United States. None of them spoke English, and I supported the family for approximately three years. They had never experienced winter and didn't have winter coats, so that was the first challenge. They received donated coats to help them with the cold. Their first trip was particularly challenging because they needed to stay in the United States, in Boston, which is very cold in the winter, for six months. So that was their first trip. They needed to stay there for six months, and I needed to prepare everything for them. First of all, I helped them with the visa process. The visa process took almost two months, and I communicated with the US embassy and the travel agency, and I helped the family to complete the paperwork and understand the requirements, including translating information. While the visa process was underway, I worked with the travel agency on the flights, the first month of accommodation, and ground transportation. Because of the child's medical condition, which caused extremely fragile skin, frequent blistering, wounds, pain, and other serious complications, they needed business class flights. Because this is not in the travel policy, we needed to submit an exception request to the sponsor for approval, and it was approved. So together with the travel agency, we booked the flights and accommodation at the hotel for the first month. Okay. Everything was set. They traveled to Boston, and I was with them all the time. They knew that I was there twenty four hours a day, seven days a week for them, despite the different time zone. It was fine for me. I was with them all the time. So sometimes our work is beyond standard travel arrangements. We need to understand the participant's circumstances and work with the sponsor to find appropriate solutions. So they got in the US. They said, oh, everything is fine, but the airline lost our luggage. I said, okay. We will deal with this later. Let's get you to the accommodation, to the hotel. So they passed the phone to the driver, who was there waiting at the airport. I talked to the driver. The driver took them to the hotel. And, luckily, there were some Brazilians working at the hotel, and they could help them with the language there. And I was also there sometimes talking to other people in English. And they liked the hotel. They stayed there for a month. And in the meanwhile, I was helping them with their lost luggage, which was never found, never ever. So I had to help them, together with the travel agency and the airline, to fill out a lot of papers to get them compensated because of the lost luggage. So I had to do things like list everything that was in the luggage. So they listed everything and put the prices they thought it was. So in Brazilian reais, of course. So I had to convert the prices to American dollars and translate everything that was in the luggage to English, and send it over to the airline. And after a couple of months, they were compensated. But it was never found. They didn't have a lot of things actually, and the airline lost the luggage. It was very challenging. They needed to buy clothes, of course, because I think they had two luggages, and the airline lost one. So they were at the hotel going to the appointments. We noticed that they needed a car to go to the visits and to go to the therapies. So we booked a rental car for them and also a long term accommodation, which was a nice house, and they were very happy there in their house. They moved to the house. And after a while, they were more confident. They made friends there. They started going to a church, and they met some more Brazilians. I don't know if the church was Brazilian or if there were a lot of Brazilians there, but they made friends, and they were happy there. After this first trip, they came back to Brazil, and we needed to organize the second trip. They told me that they wanted to take all their kids with them. So now, again, visa process, but everything was easier because it was the second time. So we got the visa for the other child, and we organized the travel for the four of them. And in the second time, everything was easier. But sometimes I helped them to communicate with drivers, to communicate with people in the street, sometimes in a shop, things like that. So I continued providing language support, but less and less. I helped the family to attend the visits. Sometimes they didn't know how to get to the visits, and I was there to help them. So I had some challenges in these three years, which were coordinating travel across the two clinical trial protocols, managing last minute requests and changing needs, and submitting budget exceptions. I had to submit a lot of budget exceptions and obtain approvals, helping the family with communications, and I also supported weekly reimbursements. I organized with them. So every Monday, they used to send me the receipts, and I used to submit the reimbursements. So I was maintaining regular contact with them through these three years, with back and forth, traveling a lot of times. But after three years supporting this family, I could see how much more confident and independent they had become. They didn't need to contact me as often as in the beginning. They made friends. They built a support network and established their own routine in the United States. And they were becoming more comfortable with their new life, and they were happy with their new life. It was very rewarding to see the change, and it showed me that my role was more than coordinating travel and reimbursements. I was helping them feel supported while they learned to navigate this completely new environment. This experience taught me that sometimes the impact of our work isn't just about solving problems. It's about being there for participants and their families when they need us, helping make the journey a little easier. We can't take away every challenge, but we can make a real difference in how they experience their journey. Thank you very much.

Carolyn Mullen — Senior Study Start-up Lead, Suvoda
Thank you for that. Thank you for sharing that story with us. When it comes to providing that support, especially cross border support, there's all those steps that go into it with the visas, with travel, with getting them the accommodations. There's so much. But you're so right that the concierge coordinators really go beyond just setting up travel and reimbursement. It really is that human touch and that level of support so that these families can really keep going with their lives. And I think this is such a beautiful example of that, even how you are able to see them find their comfort and their community within the US, and it's just such a special story to share with us. So thank you so much for that. I know with planning, much goes into things. We never exactly know what's gonna be requested, what's gonna be needed on a participant by participant basis. And I know you mentioned the travel policy and exception request. And I know for the four of us, those are everyday words. We deal with that every single day here at Suvoda. But, Kyle, can you give us just a brief overview of what exactly an exception request is and how we work that into our process with our clients?

Kyle Renick — Global Study Manager, Suvoda
Thanks for bringing that up, Carolyn, and thanks for sharing that story, Beatriz. Your story highlighted a need for the family to have different airfare. They needed business class tickets. And so when a study is being initiated with our services, Carolyn's team will work with the CRO and the sponsor to set up a travel policy so that we know what we're allowed to automatically book, and what budget limits we need to stay in. And, again, my role is to look closely at the scope and the budget. But like we've heard, we can't always anticipate what each participant is going to need. And our concierge services are built to be agile and nimble and flexible so that we can respond to those special requests when they come up, and the way that we handle them is by drafting exception requests. So the site or participant would notify us of a special need, such as business class tickets. I would work with our concierge coordinator to collect all the information and justification around that request, and then I would share that with the sponsor and the CRO for their review and, ultimately, their approval. So it's never up to the site or the participants to know what is or not within our scope. These are all steps that we handle in the back end to provide that seamless support to the participant.

Carolyn Mullen — Senior Study Start-up Lead, Suvoda
Excellent. Thank you, Kyle. I think it kind of ties back again just to that human aspect and the relationships that we're building throughout concierge support. It's really not just our coordinators with the participants, but it's also with the sites and with the client. So really making sure, we're all in clear communication throughout the whole process and just making sure as we go through each step and each visit that we are finding the best solutions for all involved. So thank you for that overview. Now we do have another coordinator here with us today, Igor. Igor, could you please share with us what region you're in and what areas you support?

Igor Paszewski — Concierge Coordinator, Suvoda
Hi, everyone. Igor here. I'm based in Poland. And during my tenure with Suvoda, I had supported approximately 300 participants within metabolic, oncological, and neurological studies.

Carolyn Mullen — Senior Study Start-up Lead, Suvoda
Excellent. Thank you for that overview. And can you share with us what does your concierge coordinator day to day look like? What has your support looked like for your participants?

Igor Paszewski — Concierge Coordinator, Suvoda
Of course. So the stories I wanted to share today, there are two stories about two participants in an oncological study. So these two participants, they came from two different sides of the country to totally different ages, backgrounds. They were as different as they can be, but somehow I feel they are connected. So the first participant, she was one of the first to onboard in this particular study for me. And when I reached out, what really surprised me was how knowledgeable she was. So she knew exactly what medication is being tested, how it differs from other medications available to her through Polish health care system. She knew how the visits are gonna look, how often. She was so prepared. So I actually learned something about the study and about how it's gonna look from her.

Carolyn Mullen — Senior Study Start-up Lead, Suvoda
I love that. I know when Kyle does his onboardings with our coordinators, when our GSMs are working through that, it is about introducing the protocol and introducing what that study can look like. But I imagine that one on one with the participant itself, especially when they're so informed of what the trial is going to be like, is such a benefit for you as a coordinator because it helps you not just with that participant but with all the additional participants in that study moving forward. So that's great. You talked a bit about kind of this conversation coming up during an onboarding. So I know Kyle mentioned earlier, there's a lot of onboarding that goes into concierge support. Can you tell us what exactly the participant onboarding looks like and what that process entails?

Igor Paszewski — Concierge Coordinator, Suvoda
Of course, Carolyn. So onboarding happens usually when the site starts screening the participant. We receive the first documentation, data consent, and some information with the participant and upcoming visits. This is when we reach out to participant and we have a conversation. Usually, I will ask how can I best assist you? How can I best support you? We would talk about how they are planning to get to the visits and also what we can offer. So we would discuss travel policy as well as the scope of reimbursements that we can cover that participants can expect so they know exactly what we can offer because things change. Sometimes we start with a basic support and then suddenly for one visit, they will require a car booking. So they know exactly how they can request this service from me. So, yeah, onboarding, is the first touch point. It's the first time, we can make a connection with the participant and establish the relationship we'll have.

Carolyn Mullen — Senior Study Start-up Lead, Suvoda
Thank you for that. Really ties back to those stats we looked at when we first started the webinar, just how participants can be hesitant because there are those expenses and that travel involved, and it's not always known right away how that will be supported. So I know with our participant onboarding, it's like you said, that first touch point. It's just a great way to really introduce our service, our concierge support, and our concierge coordinator so those participants really know that they have that support throughout the trial moving forward. So back to this first participant, can you tell us a bit more what was that like with her? What was her onboarding process like?

Igor Paszewski — Concierge Coordinator, Suvoda
We went through the policy. We had a conversation. And at the end of the day, the way we proceed, we would reimburse this participant mainly for taxis, meals, mileage to the site, but we would support her with occasional car booking as well. So the study has started. She passed the screening. The protocol visit has started. A few months went by, and then it happened. She lost her job. And when I touch base with her, she told me that she doesn't know what to do because the main issue here wasn't simply the financial one. Losing her job meant that she would most probably have to leave her apartment and move back to her family home. Her family home was a few hundred kilometers away from the study site, and the visits were two, three days a week. So in practice, it would mean that she would spend most of the week traveling. She would be exhausted, and she thought that she's not ready to continue in the study. So I didn't give up. We dusted off our good old travel policy, and we had a conversation. So I told her what is there that we can offer that she wasn't utilizing before. I mentioned the hotels, travel bookings, assisting with our reimbursements, etcetera, because the travel policy is very flexible. So for example, when visits are on Monday and Wednesday, we can arrange the hotel nights in a way that it's a continuous stay in the city. The same with travel: participants can travel by train to the visit and return by car on the way home, and we reimburse the mileage. So we work within the travel policy, and she decided to continue in the study. Surprisingly, the longest conversation we had was about the hotel. And guess what? It wasn't about getting a five star hotel. It wasn't about getting infinity pool and a sky bar. What she wanted was the quietest, the most peaceful hotel she can get, and we focused on this. She used to live in this town, so she knew a few places that she wanted to explore. And one of those places, we managed to call them up and explain what we are searching for. We're gonna be a frequent customers there, and they promise they will secure rooms facing a park for us. So she will always have quiet and place where she can recover after the visits. So she continued in the study. The visits have progressed. And then one day, she called me up. I wasn't expecting the call because it was in between the visits. So I thought maybe she was calling up with some questions about reimbursements or some unplanned visit, but it wasn't that. She was so excited. I could feel it from the get go. And she told me she wanted me to be the second person after her family to learn that she went into remission. And it wouldn't be happening if we didn't help, we didn't push that she continues in the study. So it was first time I heard news like this from the participant because I do not usually inquire about participants' health, how they are feeling, how they are doing in the study. I do not have medical training, and I am afraid these questions may lead to situations I'm not equipped to answer. So this was the first time someone shared the news like this with me, and it meant a lot. And this takes me to the second participant. The second participant, as I mentioned before, she was actually in the same study, but in a totally different site in a different part of the country. And the support we offered included mostly reimbursements. She was living quite far from the sites. And every now and then, hotel booking, and we would reimburse her for meals as well. So she would travel with a travel companion, with a caregiver, and we would assist both of them. So she was a few months into the trial, and we would have regular catch ups, touch points. Before every visit, I would check up on her and ask, what kind of support, what scope of assistance will be required for the next visit. So during one of those calls, she actually told me, "Sorry, but I think this is probably the last time we are talking because this is going to be my last visit." And I was surprised because I knew that there is quite a way to go in the protocol. So I asked what's happening. Why is she saying that? So she said that she believes that the medication is making her unwell, that she's feeling weak. She doesn't feel well. And with all the travel, she can just, stay home and continue treatment in a local facility. And she just wants to stop. So my reaction was twofold. First, we talked. As I mentioned, I do not go into medical details. I'm not a trained medical professional. We just had a conversation. I said, like, listen. I know you are fighting cancer. I don't know how the study progresses, but fighting the cancer is not the same as dealing with high blood pressure. Your body is fighting a battle, and it's gonna take a toll. And I asked her if she thinks it's worth it for her to talk to the doctor at the site. Because this is the person that can help her out, that they can answer all the questions, and they can clarify if it is the medication or the disease that's causing the symptoms that she's weak, that she doesn't feel well, and to help her deal with them. So she was reluctant. And it's important to say that in Poland, in general, the participants, they are reluctant to raise concerns at the sites. They don't want to be a bother. Sites are very busy places. There is doctors, nurses, coordinators, other participants, patients. So they are happy they are in the study. They wanna go for the visit, and they wanna go home. So they don't want to be bothered. So the second thing I did was I called the coordinator at the site. And we knew each other for a while already. So I told her what's happening. I told her, like, listen. This participant, they are considering leaving the study because they are not feeling well. And I repeated exactly what the participant told me. And I asked if maybe they can arrange for them to have a talk with the doctor. It will be beneficial for the participant. I believe it will be beneficial for them to have this, face to face time and facilitating a time and space that they feel comfortable asking questions. So the site did exactly this. They arranged, a slot in doctor's schedule, and they had a conversation. The site coordinator later called me up and thanked me for bringing this to their attention. And they say that most probably, like I said, the participant, entered in a battle mood and she was ready to quit the study. So because they were prewarned, prepared, the doctor was waiting. They had a conversation and the participant stayed with them. I don't know how the study progressed. We never talked about the participant's health again, even though she asked me if it was me who spilled the beans. And so the site was prepared. I told her, like, listen. Yes, I just flagged to them that the conversation with the doctor would probably help. So the participant continued in the study. She's now in a follow-up stage, so the visits are approximately quarterly. So we still talk, but what we talk is the weather and how the dogs are doing and not about any issues she's facing. Two participants, two different sides of the country. They never met. But in a strange way, I feel the stories became connected and that I was lucky enough to be standing in the middle. So thank you.

Carolyn Mullen — Senior Study Start-up Lead, Suvoda
Thank you. Wow. What rewarding experiences those both really were. And I think they really highlight that connection that you as a coordinator and all of our other coordinators are building with these participants. I love even the note about talking about the weather and about the dogs because there is that real human personal touch that is built through these relationships over time, supporting all of the participants. But it also shows that kind of fine line that you as coordinators really have to walk when it comes to supporting these participants because you are involved in their day to day surrounding, these medical experiences. And like you said, our coordinators aren't the medical doctors, but you are, sometimes that first line in receiving some of that information, potentially hearing about adverse events. And I just think your example there of how, your communication with that participant was really to focus on, okay. What can we at Suvoda offer from our concierge side to at least help support making the next visits easier, reducing that burden. But you also ensure that there is that communication with the site, really showing that side of our partnership as well because this is all about ensuring we are reducing participant burden, but it's so that these trials can be successful. And so we want to make sure we are supporting with that retention as much as possible. So thank you for those two stories. I love how you bring together that connection of those two participants and also showing that they start thinking they might just need reimbursement, and then all of a sudden, we realize they do need additional support. And I think that's just a great example to highlight for all of our concierge services because each visit can differ. Each participant can differ. So when we're working with clients to build those travel policies, sometimes it can look like here's the full scope of support that is available. But, really, that can all be, in a sense, picked apart and used in the custom ways we need for each participant and each visit. So it's just, again, a benefit of that concierge flexibility that we can offer. But Beatriz and Igor, just thank you so much. Thank you for being coordinators. Thank you for being here with us today and sharing these experiences. Really helps us see again that human side of the concierge services. But I think what we also wanna kinda tie up today is all of that full study impact. So we talk about our coordinator support, our site support, really guiding the participants through and working with the clients. There really is a whole tree of support that our concierge team is offering. So, Kyle, I wanna jump back to you and just, help us kinda see what is really that overall impact that trials could see when they're working with our concierge support services.

Kyle Renick — Global Study Manager, Suvoda
Thanks, Carolyn. And thank you, Igor, for sharing those stories. I think we can look at the stories that Beatriz and Igor have shared today as not special cases. Those are not very unique circumstances, but those are the type of stories that they have with every participant that they work with. And so there really is no replacement for the high touch support that our concierge coordinators bring to each study, and they ultimately are lowering that barrier for participants to continue in the trial for as long as possible. I think the audience has some handouts that highlight some exact figures. One of the biggest ones I wanna touch on is that we know that losing even a single participant in a clinical trial can cost sponsors as much as $150,000 per participant. And that is a monetary value, but it doesn't even capture the value lost in the data or the experiences of the participant. So there's no part of Beatriz's or Igor's job description that says make sure you keep the participant in the trial, and yet that is ultimately one of the largest effects that they have as concierge coordinators. We also know that many participants cite travel burden and uncertainty around reimbursements as some of the biggest factors that determine whether or not they're going to remain in a trial. And so just having that human contact to be able to pick up the phone and ask a question, will I be reimbursed for this expense, or will you be able to help me pay for this travel? And to get that answer from a person pretty rapidly, we know that does a lot for the participants' experience. And our concierge service is what we're talking about today, but it is just one piece of the overall Suvoda offering. Our technology side, our IRT, eCOA, eConsent are there to support sponsors and CROs so that they can facilitate their trial as effectively as possible. And then our concierge model is there to support the sites and the participants so that they have that human experience to be able to ask for help from a person. And then together, this helps create the all in one platform that Suvoda offers to help clinical trials be successful.

Carolyn Mullen — Senior Study Start-up Lead, Suvoda
Thank you for that. Really ties just right back into when we're looking at trials and we're looking at patient centricity, we have to think about that burden. And I think here at Suvoda, that's really always our goal with all of our platforms and with all of our different delivery models that we can offer, we wanna really look to see where is the burden and where can we really reduce that so that we can support these trials, support that retention, and just help everything be a success. So just thank you, all of you, for your time today, Kyle, Beatriz, and Igor, for sharing your experiences, your story, and also just being on the front line every day with the concierge team, really is showing us what a difference that concierge support can make. And, again, we have 75 concierge coordinators supporting these participants around the world. And every day, they are handling all different tasks that come at them. And it can be big tasks. It can be small tasks. There's so many details that go really into all of the work behind the scenes. So just a huge thank you to all of our coordinators as well as all of our global study managers, all of our study implementation team, everyone that brings together that concierge support full picture. Just thank you for the work that you do because that work is really letting our participants focus on their health and focus on the study. So thank you all for all of that. And also to the audience, just thank you all for joining us today. We really appreciate your time as well as your commitment to really making clinical trials easier for the people who take part in them and looking into learning more about the Suvoda models and delivery experiences. But with that, I believe we're going to jump back to Ryan, see if there's any Q&A from our audience so we can answer some questions to close out the webinar.

Ryan Muise — Host, Xtalks
Well, thank you all very much for this very insightful discussion today. As we as we move into the Q&A session, I do wanna direct the audience's attention towards the handouts. You'll find some additional materials related to today's presentation to download for further reading. I also want to invite the audience to keep sending their questions or comments right now for this Q&A portion of the webinar. If you're watching via GoToWebinar, you can use the questions window. And for those watching on LinkedIn live events, we'd love seeing your comments coming in the comment section. I have received questions from the audience already, so we're gonna get ourselves started with those. And looking here, the very first question that I have wants to know just how far in advance does concierge setup need to start? Further, can it be added mid study if retention issues emerge?

Carolyn Mullen — Senior Study Start-up Lead, Suvoda
Sure. I can jump in with that, coming from the startup perspective. So concierge implementation, we do have kind of our typical timeline where it takes about eight to ten weeks to implement the service, and that's really looking at all of the startup that goes into it. So really kicking off the study with the clients, working with the sponsor CRO to develop what we want those travel policies to look like, what we want the portal configuration to look like to make everything, again, as easy as possible for sites and for the participants. So that's really what we focus on in that first startup period before we officially turn it over to Kyle and his team for all of the recurring study management. Now in terms of bringing concierge on kind of a different point in a study, we have seen that happen. It is something that we can always work together to discuss what that would look like and what that timing would look like. It's really important to kind of make sure that we're jumping in at a time that can really be still a seamless transition for participants. So always something where you can start the conversation, of course, with our contracting team, but also they will bring in our team to really help support what that outline and timeline will look like if that was something needed. Great question.

Ryan Muise — Host, Xtalks
Alright. Thank you so much for that answer. Next up, someone's curious if reimbursements for any expenses incurred are also covered, and sort of what does that process look like?

Kyle Renick — Global Study Manager, Suvoda
I think I can jump in on that question. During study startup, we will work with the sponsor and CRO to determine what expenses are already preapproved for us to reimburse. Those are typically meals, mileage, parking fees, tolls, any expenses that a participant may incur in order to get themselves to a clinical visit. And then for anything that isn't already covered by those categories, if participants need reimbursements for other expenses, then we handle those through exception requests. And was there another part of the question that I missed?

Ryan Muise — Host, Xtalks
I guess they're just wondering about the process. What does the process look like?

Kyle Renick — Global Study Manager, Suvoda
So the process for reimbursements is based on receipts. So one of the topics that our concierge coordinators discuss with participants during their onboarding is to retain all receipts for anything that they do pay out of pocket, and then we reimburse them based on those amounts on the receipts. We associate the dates on the receipts with visit dates and make sure that everything lines up. And then we are adhering to our travel policy that's been established with the sponsor. And for anything that's not covered by that travel policy, that's again where those exception requests come in. Reimbursements go through our Suvoda pay portal. Participants have a few options for being reimbursed for their expenses, but they'll all go through the Suvoda pay portal. And so once a payment is approved for reimbursement, then they will immediately receive those funds in whichever method they have set up for reimbursement.

Ryan Muise — Host, Xtalks
Alright. Perfect. Excellent. Thank you so much. Next up, I've got a question wondering whether, considering GDPR, you can ask why a participant wants to discontinue from the trial?

Carolyn Mullen — Senior Study Start-up Lead, Suvoda
That's a great question. So, of course, when it comes to all of our concierge support, there's a lot of compliance that goes into it and a lot of safety around participant information and what is being shared with us. So first and foremost, this kinda goes all the way back to startup, but we do create what we call a data protection notice. This is one of our patient facing documents that really walks them through what type of data we may request and how we could utilize that data. Now something like a participant telling us that they wanna discontinue from a trial, sometimes that's being communicated to us in the same way that Igor experienced, where it's more being communicated that this is gonna be their last call with the coordinator, that they don't need any support moving forward. From our side, we don't wanna jump into asking any specifics about their health or their specific participation in the trial, what we really try to focus on is that concierge support of is there anything that you experienced with our team that we can do better or anything that we can support differently moving forward. So it really is trying to find that kind of line of making sure we're not asking for any information beyond what we would need to provide our support services as noted in our DPN or data protection notice. But, again, with participants, sometimes that information can be readily provided to our coordinators. That, again, is where they're trained to really make sure they're seeing what information is coming in, being careful, of course, with any dissemination of that information, and ensuring that site is still in communication to help support any of those questions. Also, just to note there, it can vary country to country, and that's a huge thing we take into consideration as well. So regulations vary. I know GDPR, even in France, things can be very different with regulations. So we really try to focus on that kind of country by country expectation and how we can best provide that support while staying within line of all of those regulations.

Ryan Muise — Host, Xtalks
Perfect. Thank you so much. Now moving on, we've got another question here. Wondering what happens when a patient needs support that sort of falls outside the defined scope of the concierge program.

Igor Paszewski — Concierge Coordinator, Suvoda
So, for example, a real-life example: the travel policy says we can provide one night in a hotel for a given visit for participants. And this participant travels to the visits by train. So they will arrive a night before the visits, in the city, and they can spend the night before in the hotel. But the next day, the visit lasts ten hours. So they will finish the visits, and then the next train is six hours away or seven hours away. So they would have to do something with themselves. For this time, they are already exhausted after the visit. So in this case, what I will do, I will gather the information quotes, rationalize it, what is the reason behind the exception, and I will submit the request with approximate cost, which I will include the cost of the hotel, the meal allowance that can be utilized during this time, and I will submit the request to a GSM. And then the GSM takes over.

Ryan Muise — Host, Xtalks
Perfect. Thank you so much. Now next up, someone's wondering how this is funded. Is it usually built into the sponsor's study budget, and how are participant expenses handled?

Kyle Renick — Global Study Manager, Suvoda
I can take that one again. So our budget is set up as a part of the overall study budget. We're allocated a certain amount for pass through costs, which are used to cover travel and participant expenses. And, again, the expenses are handled through our Suvoda pay portal. So once a participant has opted into our service, they will be introduced to their concierge coordinator who will then help them to facilitate those reimbursements. So that means, letting them know what their meal limit is per person per day, reminding them to save their receipts, and then ultimately, the participant or their travel companion, whoever's managing the paperwork, will share those receipts with our concierge coordinators, and then we will use our Suvoda pay portal to issue those funds back to the participant through whatever payment method they've selected. We have physical cards, and we have bank transfers. And then we can also issue paper checks.

Ryan Muise — Host, Xtalks
Perfect. Thank you. Now another question here wants to know, do you also help with patient recruitment in case of rare diseases, or does the support start after recruitment?

Carolyn Mullen — Senior Study Start-up Lead, Suvoda
That's a good question because I would say, technically, our services are not part of the actual recruitment process. However, what we find is that when our services are kind of identified as being available early on in the study, that actually can support the recruitment process. So when sponsors are able to share that there is going to be a vendor available to provide prepaid travel, that can really support that opt in to the study before the participants are even choosing to opt in to Suvoda. So I think in some ways, yes, we are supporting that recruitment process by being a part of that burden reduction available for participants.

Ryan Muise — Host, Xtalks
Alright. Perfect. Thank you so much for that answer and for all of your time today, but we have reached the end of the Q&A portion of the webinar. Please know that if we couldn't attend to your questions, the team at Suvoda will follow up with you. Or if you have some further questions, you can direct them to the email address that's up on the screen. I want to thank everyone, though, for participating in today's webinar. You will be receiving a follow-up email from Xtalks with access to the recorded archive for this event. A survey window will be popping up on your screen if you click the exit button, and your participation is appreciated as it helps us to improve our webinars. Additionally, I've shared a link to view the recording of today's event in the chat box, which you can also share with your colleagues so that they may register for the recording here as well. For those watching on LinkedIn live events, we encourage you to visit xtalks.com to register for this event and gain access to features such as viewing that recording and more. Now please join me once more in thanking all of our speakers for their wonderful time here today. We hope you found the webinar informative. Have a great day, everyone, and thank you for coming.

Carolyn Mullen — Senior Study Start-up Lead, Suvoda
Thanks all.

Ryan Muise — Host, Xtalks
Thank you.

Beatriz Oliveira — Concierge Coordinator, Suvoda
Thank you.