Alleviating Site Payment Burden with Third-Party Services

In this episode, Jimmy Bechtel sits down with KimberLee Heidmann, Executive Vice President of Quality and Regulatory at Scout, to discuss the financial and administrative challenges clinical research sites face when managing patient payments and reimbursements. They explore how cash flow gaps impact site operations, why sites are adding overhead fees to contracts, and the burden of unexpected participant costs. KimberLee shares practical insights on how service providers like Scout can remove these pressures by handling logistics and payment services directly, allowing sites to focus their time and resources on what they do best: conducting trials and caring for patients. This conversation offers a fresh perspective on streamlining site operations and improving the trial ecosystem for everyone involved. 

Transcript

Jimmy Bechtel 0:00

Welcome to SCRS talks provided by the Society for Clinical Research Sites. Thank you for joining us as we explore the latest trends, insights, and innovations shaping clinical research today. I'm Jimmy Bechtel, the Chief Site Success Officer with SCRS, and I'm joined today by KimberLee Heidmann, the Executive Vice President, quality and Regulatory, and the Data Protection Officer at Scout. KimberLee. I'm really excited to have you today and to talk a little bit about payment burden that sites and patients face and some of the cool things that, we are seeing being done in the industry to solve some of that.

KimberLee Heidmann 0:35

Yeah, absolutely. Thanks Jimmy. I'm always excited to talk to our partners at SCRS, so thanks for allowing this. yes, I am currently serving as the head of Quality and Regulatory Affairs at Scout. I also serve as our data protection officer. I've been with the organization for 25 years, and so I've had the opportunity to hold several different positions. At the organization and learn a lot about research. Before I was at the company, I worked for a subsidiary of the World Health Organization, and so have been in the research space since the late nineties. it's a joy to be able to work on more of the patient facing side. Now, here at Scout, what we do in our clinical division is that we provide support to research sites and participants of clinical research by providing logistics services and payment services to the participants to offset any financial burden, and also logistical burden. That's. The goal and the desire of Scout to really enhance the health of people by supporting research around the world. We are a global company and so we have the opportunity to work with sites and participants all over the world, and we are contracted by the sponsors and the CROs to provide that service, in our meetings division. We provide training and trial collaboration with the research sites, bringing them to all different types of meetings, including investigators meetings, advisory board meetings, et cetera. So really offering the full, scope of our services starts with education and training and collaboration, and goes all the way to trial participation and retention. so that's what we do and why it's very important to us that we partner with SCRS.

Jimmy Bechtel 2:23

Excellent. Thanks KimberLee. Thanks for expanding on that. And yeah, you know, we value partnership, and partnership is exactly one of the ways in which we go about solving some of these challenges and learn together around payment burden that the sites and the patients face and sites often. Pay as we know, some of those stipends and other costs upfront before the sponsor payments arrive. So they're footing the bill, if you will, or fulfilling their needed obligation to the patients who are participating in these clinical trials. So how does that cash flow gap impact site operations and sustainability? I'm really interested to hear your perspective on this being, with your background as well as, you know, being at the service provider perspective.

KimberLee Heidmann 3:07

Yeah, so we have done quite a bit of research and we have a site engagement team that does a lot of work directly with the sites, talking about these various, types of issues, specifically the cash flow question has come up quite often and also in some of the, work we've done with SCRS doing surveys of the site. One of the things that we learned is that the approach to cashflow does vary. and you understand that how sites manage, their overhead and their cashflow and how they pay out, their invoices and request invoices. It does vary across those small independent sites to larger sites organizations. But one thing is always true. The outlay of cash for participant stipends or real-time logistics management, those things hit the site's daily operating expenses, so they're often not remunerated quickly. the sponsors and the sites are doing the best they can. CROs are doing the best they can, to make sure that site payments and the offset of those expenses is done quickly. However, there are timeframes involved and there's just the nature of the business and moving those invoices and payments back and forth. So the gaps in that timing creates a tension in the site, cash flow, and that. Impacts the other site expenditures. All these sites know if you're waiting for that payment for the outlay of cash that you've done for logistics and stipends, which is real hard dollars, then that could impact other expenditures at the site like staffing. which without staffing and without paid staff, you can't keep the trial running. So over time, you know, these gaps tend to snowball and make that tension greater. You also have to consider high volume trials. You know, when sites are putting out funds for stipends or reimbursements, or they're actually putting the time and effort into organizing the real time logistics, high volume trials accelerate that problem. So what we see is really that sites and sponsors can work together on this problem by, first of all. Eliminating the unnecessary expenditure. So the first step that we would recommend is well just don't put that on the sites to have, to actually have to make those payments or provide that logistics support in real time. And then also there, obviously the other offsets that can be done, which would be, you know, monthly payment models or advanced payment models to sites. But If the sites don't have to worry about this and they actually don't have to take that money out of their reserves, then the impact is mitigated completely.

Jimmy Bechtel 5:59

A lot of great points there, KimberLee. I really appreciate the perspective around, I guess the solution around, let's not even put it into the realm of worry at the site level. Let's remove that as something that they have to worry about. There's a lot of different ways we can do that. You mentioned some of them, like paying on time, paying monthly and prepaying for those things and making sure that the sites have those funds because you're a hundred percent correct. In that we see so many sites that live, you know, quote unquote write paycheck to paycheck with their clinical trial, reimbursements and expenditures. So when we have to take from Peter to give to Paul, as it were, it's challenging for the sites to understand and prioritize how that's going to happen, especially in tighter times.

KimberLee Heidmann 6:44

Yeah.

Jimmy Bechtel 6:46

So we're also seeing KimberLee sites add overhead fees to these contracts to cover some of these administrative burdens of managing some of the patient services themselves. So what's driving this trend and what does it say about the current ecosystem when sites are having to go about doing things this way?

KimberLee Heidmann 7:08

Well, I think it's, you know, we've built on this topic and what we've already discussed, payments to clinical trial participants and the cost of logistics support. That's real dollars. It's real dollars and time. Many of these sites may not have, the staff to allocate specifically to this activity or the additional time for administrative activities. So payment reconciliations, certain things that are involved in tax reporting if you're providing stipends. So it's very hard because you don't know what these costs are going to be. It's very hard for sites to project the cost and the impact at the beginning of budget negotiation. So, for example, if a site has been involved with with certain. Studies where they've provided these services in the past and they've had to outlay these funds in the past. They may have that anecdotal experience, but they may not have the bandwidth or the internal systems to actually track that so that they can quantify it when they're projecting their budgets. some sites talk about, needing to incorporate the overhead fees to protect themselves, right? if I'm going to. Incur higher costs and sometimes costs for stipends or, logistics can go up year over year. And especially with higher volume studies, it's hard for them to project, so they really need to be. Clear and they need to be proactive when they're looking at those overhead fees and when they're looking at those expenses. And you know what it says about the current system, in my opinion as a provider in the space, is that there really is an undeniable benefit. Two sites to pivot away from what they may have always done, which is doing this themselves, taking on the administrative and financial activities of, of organizing and coordinating and paying for logistics and, and stipends and reimbursements. They may have always done that before, but really there's no question that there's a benefit to taking advantage of, the shift we're seeing with sponsors where they're using third party providers like Scout to remove that burden. it's really becoming an undeniable fact, although early in our days when I would sit down with sites and, leaders in the industry. They would often say, well, there is this thought from sites that, companies like Scout and Scout in particular might be taking away, some opportunity for a site to have additional fees or services that they're providing and take advantage of those fees. The reality is it's more of a burden on the site to provide the services and have the internal systems. And administrative activities then, then it's worth, so I think that's what it says about the current system. We want the clinical trial sites to be able to put their resources, their finances, and their time into what their experts at, which is conducting the trials and. Along with the sponsors that Contract Scout, we see the value as the experts at what we do, and letting us do what we do really well, and that's making this process a whole lot easier and removing that burden from the sites.

Jimmy Bechtel 10:35

I couldn't agree more. KimberLee, we talk about this concept now with, the implementation of AI under clinical trials. This is a really great example of a way that we can remove the quote unquote administrative burden. All these extra ancillary tasks away from the site where they might not be proficient in it or experts in it, or efficient in it, like, service provider might, but also. Be able to have the ability to dedicate their time to more value add activities and drive additional trial revenue, see and treat patients. The most important thing, like you said and stated so eloquently, they're here really to do so. Moving when we see these additional things being tacked on or added into our overhead fees. It's a sign of the times or a sign that something isn't right, because anytime we're having to add something to overhead, overhead beyond your standard inflationary costs for things that are probably unavoidable, we do start to see some problems that arise from that.

KimberLee Heidmann 11:37

Mm-hmm.

Jimmy Bechtel 11:38

Patients sometimes face unexpected, medication costs related to trial participation. We know this isn't uncommon. it remains an issue within the industry and. Sites really are on the end trying to troubleshoot these issues of where are these costs coming from? Why are they happening? So where should the responsibility for some of that lie? And how can service providers like Scout really help with, managing that additional, you know, what one could argue is a related administrative cost.

KimberLee Heidmann 12:08

Yeah. You know, I have been very fortunate that in a lot of the trials that we've supported of late with the sponsors that we're working with, they have anticipated because we've seen this, I think Jimmy, this is. Important to note that this is not a new thing that we're seeing, right? unexpected medication costs. You've also got the cost of unexpected imaging or tests, labs, other health related expenses that sometimes occur. And there's been conversations in the industry about how do we work with insurance? How do we work with patients that don't have that? How do we cover these costs? How do we anticipate them? And. One of the things that I've noticed, because Scout often has the opportunity to talk with clients about when they're looking at populations or looking at more complex studies and they're asking us, what do we see, we're saying, well, there's a way to provide for this. There's a way to provision this so that the sites are not scrambling, and the patients are not burdened The way to do it is talk about it in advance. When you're looking at the protocol design, the study design, and you're thinking about your population. You're thinking about your location. These potential unexpected costs are, are things that arise, are something that can be considered just like I would say the, unanticipated barriers to logistical participation can be anticipated, right? We just have to have those conversations and say, what are the chances that this could happen? Now, we can't anticipate everything, but what we can say is. Our previous historic experience tells us. That this is a possibility. And what are solutions that we can put into place at the very outset that don't really cost us anything unless we get to that bridge? If we get to that bridge and we have to cross it there, there's probably gonna be some expenses. But let's put the regulatory in place. Let's put the right providers in place so that if we get there, the sites aren't scrambling. So if there are, potential expenses that, patients may have incurred during this study that we're not sure about, these could be labs, very specific, dietary regimens or over the counter products, things like that, that might create an additional burden. And when the patient says, I can't do this. How am I going to pay for it? That study coordinator is thinking, we gotta do this to stay adherent to the study processes. So now I gotta scramble to support this patient. So rather than doing that, let's put the regulatory in place. Let's have the conversation in advance and put the tools together in the toolbox to solve that problem. If we get there, and that's something that Scout has a lot of, its. Experience with, and we've done. So I always say just let me engage in the conversation with the project teams or with those folks at the sponsor or the CRO that are discussing this so we can put together some solutions.

Jimmy Bechtel 15:21

That's really excellent, KimberLee, and exciting to hear that there's a path forward for that. I know we'll get into that in just a moment as we begin to wrap our conversation up, right? We've been talking a lot about the challenges and setting the stage for what the industry is seeing and what the trends are. And you bring some great points up around this theme of, you know, let's do the work to identify what some of those administrative burdens are and understand how they affect. To site and then build solutions around those. How does Scout help alleviate the financial and administrative burdens that sites face when they're managing this concept and, and this, this task really around patient payments and reimbursements.

KimberLee Heidmann 15:59

So I think the first thing just to remind our audience is that scout services are generally provided via our contract with the sponsor, or the CRO for a trial. What we've seen in the industry is a greater level of adoption by sponsors and CROs to utilize and partner with, to collaborate with companies like Scout and, and I would say Scout is, is leading in this is to, to pivot away from the way that things were done previously and think in a fresh, new way about. Incorporating scout into their ecosystem. And so even in countries and cultures where we see a slower uptake on sites pivoting away from doing it how they always have, the first thing is for sites to understand that this is something that Scout does, under contract with the sponsor and the CRO, and then we can provide those services. To the sites in a much simpler way for them. and it's really important for the sites to know that, that it's, it, this is just adoption on their part, right? We do everything we can to reduce, their having to sign on to. Additional, tools. In fact, several of our large sponsors, we have SSO integrations. We try to make it as simple as possible for them to access our systems. We really just wanna promote that adoption and make it simple. if they can see that and understand that foundationally, then they understand that the impact of using a company like Scout. Starts from the outset because you don't have to worry about how you're going to address. Stipends payments, retention for, you know, based on overcoming burdens for logistics. You don't have to think about that when you're doing your budget projections and your CTA negotiation. you know that that process is going to be turnkey, in terms of utilizing scout. So I think that's the first way that it really, it starts at the outset. Budget projection, CTA negotiation. Then it translates into the day-to-day, you know, the resourcing at sites, staffing burdens. Sites can begin to think differently about how they staff and where they put their talent. If they know they don't have to put their talent into these administrative activities around these patient services. And that goes all the way down through, we have sites that are asking questions and are concerned about tax reporting, acting as a payer, how do I do this? Well, you don't have to put the time and energy into thinking about that or staffing it, or thinking about the internal systems to track and measure it. If you can adopt the services that we're allowing so, or that we're providing via the sponsors. This lets the sites really put the emphasis on conducting the trial, like we said earlier, and meeting the timelines and at the most important level on patient care, right? Spending more time at the visit with the patient rather than saying, okay, let's spend 15, 20 minutes going over your receipts. We don't have to do that. They can take the time, with their patients and it maximizes efficiency for the sites. And to be quite frank, for those who are managing the sites or own the sites, it impacts their bottom line. So I would say that a well structured. Strategy for logistics and payments to the participants, really is fundamental to the efficiency of trials, also fundamentally to participant centered research. As you know, we've talked with SCRS quite a lot about this, and we believe that utilizing Scout as the premier partner helps the entire trial ecosystem. You streamline the logistics, the payment mechanisms, you reduce recruitment and participation barriers to reach, more diverse populations and improve trial outcomes. At the end of the day, the positive impact on trial sites who use Scout is very fundamental. reduce the time and money you're spending on budget negotiations and overhead. Free up your cash flow for what's necessary for your business to succeed and focus on patient care. Meet the study timelines. These are the best outcomes for every stakeholder in our industry.

Jimmy Bechtel 20:30

Thanks, KimberLee. I think it's, a really strong case for going down these kinds of paths and enabling these kinds of augmentative services onto clinical trials. Some of what you've heard from the sites and kind of dig into where things are at. But we're out of time for today. So maybe a conversation for another time. But, really thank you and thank Scout for the time today and for building solutions with the sites and the patients in mind. again, excited to continue to bolster the partnership that I know we continue to establish. Again, site. Thank you.

KimberLee Heidmann 21:07

Thanks, Jimmy. It's been wonderful talking with you as always.

Jimmy Bechtel 21:12

I couldn't agree more. And for everyone listening, I hope that you make sure to check out other great site focused resources made available to our entire community on our website, my scrs.org, including other podcasts and webcasts like this one, and opportunities to become involved with partners like Scout. Thanks for tuning in and until next time.