Fast Payments, Stronger Trials: The Key to Site Sustainability

Michelle Ray, Director of Customer Success with Greenphire, explores the challenges that delayed payments pose to research site sustainability. Michelle highlights key issues like the burden of delayed payments on site operations and recruitment, the complexity of invoicing, and the role of technology in simplifying payment workflows. Learn how innovating payment systems can streamline financial processes, creating a more sustainable future for sites, patients, and sponsors alike.

Transcript

Jimmy Bechtel: 0:00

Greetings and thank you for being part of the Society for Clinical Research Sites for SCRS Talks. I'm your host, Jimmy Bechtel, the Vice President of Site Engagement with the Society. Get ready to dive into pressing clinical research industry topics, celebrate noteworthy achievements, and learn more. And create a deeper connection within the research community. This is a space for us to amplify voices and perspectives that shape the landscape of clinical research. Today, I'm lucky to have Michelle Ray, the director of customer success with Greenphire, an organization that has been part of and in support of SCRS and our sites for many, many years. And we're here today to talk a little bit about how site and patient payments impact site sustainability. Michelle, it's great to have you with us. Really excited to talk about this ever present, ever important topic. But I'd love to start first with learning a little bit more about you and your background.

Michelle Ray: 0:59

Absolutely, thank you, Jimmy. It's great to be here. Thank you everyone for listening today. So I have been in the clinical research industry for around 20 years. The bulk of my time in industry has been working for CROs. I've held multiple roles in CROs. One role I was similar to what a remote monitor is, where you review reg docs, you submit the IRBs, in those types of things. The bulk of my career has been really around site payments. I was a region lead for site payments for probably about 10 years. And we did do global payments during that time. But. Had about 100 people under me and about 150 studies that were global studies. From there, I moved into a site network owned by CRO. I was the director of project management, so I got exposed to a lot of the challenges that sites face regarding a lot of different aspects of clinical trials. Part of that is definitely site payments. And then from there, I moved to Greenphire. I've been with Greenphire almost a year now. I was actually introduced to Greenphire through a society of clinical research site meeting, which was amazing. My role here is to develop a customer success team geared towards CROs and what CROs needs, just a bit different from what, sponsors need. So that's, that's where I'm at today.

Jimmy Bechtel: 2:23

Excellent. Well, thank you, Michelle. Thank you for that great introduction. Again, good to have you with us and talk about this because we know that the current state of site payments obviously impact site sustainability tremendously. It's been an ever present issue in the industry with many sites reporting that their AR, their accounts receivables, oftentimes are more than 90 days past due. So from your perspective, having, spanned the industry here, what are some of the more common challenges that sites might encounter with trial payments and also, then, of course, speaking to what that impact ultimately is on the site.

Michelle Ray: 3:00

Well, the first thing I think is important for us to talk about is that when we say 90 days past due, the key words are past due. A lot of times, if it's 90 days past due, because so many trials are really still quarterly payments, you're looking at around 180 days from the date of service, if the service was started at the beginning of a quarter. And that has a substantial impact on sites because they're paying their staff every day from day one. And so, looking at the fact that they don't get reimbursed for the work they do for such substantial periods of time is just very challenging. I've even heard comments, actually at the Society for Clinical Research Sites meeting that I attended about 7 years ago. I heard comments from sites saying that they feel like they're funding clinical trials because it takes them so long to get reimbursed. So again, just wanted to call that out from the question, but there are definitely things that we see as common trends. One is definitely we need to increase the frequency of payments. if we cannot do that, if we have sponsors that are dead set on the 90 day payment terms or quarterly payment terms, we need to find other ways to get money to the sites sooner. One example of this is a lot of trials will have study advances. What happens with a study advance is the site has to reimburse that study advance at the beginning of the trial as they're earning money. However, that doesn't sustain them through the life of the trial. If we can find a way to have a study advance that leads them to the end of the trial and they reimburse it at that point, that would make sure that they have money to fund the trial. Another thing is we need to simplify the process. Unfortunately, the reality is that anything related to money is auditable, right? And anytime there are audit findings, we tend to make the process more complicated to avoid the findings from a corporate perspective, and from a protecting the sponsor perspective, but the more you complicate it, the more difficult it is to get payments to sites. So if we can find ways to simplify the processes as a whole, then we will make life better for everyone.

Jimmy Bechtel: 5:04

I couldn't agree more, Michelle. A lot of that simplification of what all that process is really sometimes what gets in the way for sure.

Michelle Ray: 5:11

Absolutely. I think, you know, one of the biggest challenges that the sites face is just trying to create an invoice that both reflects the work that they have done, but then also replicates the work that the paying company has deemed ready for payments. It's a very difficult gap to bridge for a lot of sites. And I know this because there were so many sites where I saw a ton of back and forth where they send an invoice and the invoice would be wrong. We'd explained to them why it was wrong. They revise it again. They still didn't capture all the different pieces. And so I think that that is just a cumbersome process as a whole, and honestly, really unnecessary with where we are in tech today. I think that some of the times the variance is because there may be delays in monitoring, there may be delays in you know, incorporating the data into the EDC systems, maybe it's the EDC triggers, could be just backlog at one of the locations. But again, if we can move past those trends and look at systems like our GPS system that pulls the data directly from EDC, Then also like in systems where we can create the invoice for the site if the site's willing to use our invoices, then there's no need to do that match back and forth because it is based on what's ready to be paid in EDC. That's definitely something that is very beneficial to sites. Another thing. I think that we have an opportunity to have an even bigger impact, and this is not something that would be within our control here at Greenphire, it really would take a tech. But when you think about it, Jimmy, when a protocol is designed, what is the expectation? Is the expectation that everything should occur according to the plan of the protocol, or is the expectation that, some of the things will occur, right? Would you agree that it's according to the plans of the protocol and most normalities?

Jimmy Bechtel: 7:00

Absolutely. Yeah.

Michelle Ray: 7:02

So think about this. So if right now in current state for systems, let's say CTMS is for an example, we're expecting whether it be the CRA or the site using their own CTMS or whomever, we're expecting them to record everything that happened on behalf of a clinical trial. What if we flip the switch as a whole within industry and instead of recording what did occur, we record what did not. Imagine how changing that mindset as a whole would relieve burden off the sites. Because again, the expectation is that 80 to 90 percent of it should occur. It would reduce the timeline of our monitors, of our project managers, everyone all the way down from the beginning, even through payments at the end, because you're looking at a smaller subset of the data. Again, things like that are things that we don't have a solution for right now in the industry, but we really need to reconsider what we're doing and understand is it really necessary and see if there's a better way? Another thing is super time consuming for sites is one off payments. Every time there's a payment that is not in the standard visit scope: it's the unscheduled visits, the reimbursements of travel, if there are different types of, let's say, CT scans that can occur, trying to capture what really happened versus, again, it would vary based on the subject, capturing those things, having to upload them, having to record them, having to invoice for them, ensuring that, what's invoicable matches what's been reflected in the EDC systems, things like that are super cumbersome for a lot of sites. It's one of the things I know here at Greenphire, we recently spent a lot of time working on and we created a bulk invoiceable process. And I think that that's helped a ton. But there are so many instances where there's not an option for how to do that more efficiently. I think that that is really an area of focus that could help the sites. Another thing that's really eye opening for me was, when I was at the site network and even before even that Society for Clinical Research Sites meeting that I attended, hearing how many times the site staff that are seeing the patients are also the ones invoicing for these calls. They're managing dual roles. And so the more complicated we make these things, the more difficult it is for them to spend time with the patient, which is the primary purpose of these trials, right? To help patients get well. And so even my own child's pediatrician. We were sitting on the ball field one day. She randomly sat beside me and we started talking and she was telling me that in her business that she as the pediatrician is expected to chase when payments haven't occurred. She has that responsibility and every doctor in that practice has that responsibility. So when you think about how all of these complexities and trials associated with pain, this is pulling people away from seeing the patients and how they don't have people that that is their primary focus, if there are smaller practice, that's like mind blowing to me. And then I was at an investigator meeting and I had the opportunity to sit with a whole table of P.I.s and sub I.s at dinner one night and we were talking about some of the challenges with payments that they've encountered. And I was just appalled at some of the things that I learned in that environment. I had a sub I who told me that she did not even bother to try to get reimbursement for certain fees, so maybe a dry shipment, or let's say a travel in a car, like a taxi to a site. Because what she explained to me was that the cost on the site that it takes to gather the information, record the information, redact the invoices, submit the invoices for payment and then to get reimbursement and to chase it multiple times in many instances that it cost her money more than it would cost her just to absorb the cost of the visit. I mean, to me, that's mind blowing, how we have created a scenario for sites where we've made it so complicated that it's not even worth their effort to get reimbursed. And so, things like that are definitely something that we need to continue to have discussions about and find ways to do better and cheaper. And there are definitely softwares out there that do this. So, an example, we have Clean Card and patient direct to patient reimbursement for travel and those types of things. We have ability to do macro payments and again, there are others as well who have some of these abilities. But looking at and investing in these things, the sponsors of CROs looking to invest in using these types of services just to make sure that the sites aren't the responsibility of paying for the clinical trials, that's what it's going to take to change that mindset in industry. Another thing that I think is really important: contract language. I cannot tell you how many times I ran into scenarios where something occurred at a site and a sponsor required an amendment to the contract in order to reimburse the site. I've seen sponsors who had in their contracts language that,"Hey, we just need written confirmation." Others that truly required that amendment every time. To have to go through the efforts of amending a contract to cover something as cheap and simple as dry ice is just profound. The amount of cost it takes to the site to do that, the amount of time and labor for the CROs and for the sponsors to get to that, we've got to make sure that our contract language is clear and that it allows for some variabilities, that maybe were not anticipated, without necessarily having an amendment. Again, at the same time, we don't want to make it so free form that it gets out of control. There's a balance there, but it's definitely something that we can do to improve the scenario. Also something that a lot of people don't realize is that a lot of times the person paying the site is a middleman. And so when sponsors have contract terms that are 60 to 90 days to pay, let's say a CRO, and then the CRO has to go through a payment process that they can't start until they receive the money to pay the site, that also trickles down to the site. And so a lot of times where it may appear the problem is, that may not necessarily be where it is. But even reducing the payment terms and the frequency to that person executing payments, something like that would have that positive impact to the sites downstream. I know I've just gone on a long tangent.

Jimmy Bechtel: 13:28

It's good, Michelle, because it emphasizes the point that there are a tremendous number of challenges. Yet, they're all interrelated. And one of the major things that I really heard from you, and you mentioned it in the beginning, as you talked through, you know, some of these challenges and at a high level, some of the solutions is a lot of this is process related. We have very convoluted, bureaucratic, lengthy processes in place in order to initiate and manage these payments. And some of that is related to regulations and laws, and very important reasons, but I do wonder if there are places, and you did touch on them which is great, and we'll get into that a little bit more, there have to be places that we can streamline these processes and we can make them a little bit easier for people to execute and for people to understand what's going on. And I also do wonder too, how much of this is a transparency problem. We're just not transparent with each other on the stages and steps and actions that need to be taken related to initiating and completing payment that it again continues to add to some of that convolution and challenge with what we're trying to accomplish here around speeding patient and site payments up.

Michelle Ray: 14:40

Absolutely. I do think a large part of it is transparency. We all are trying to help each other to move toward the solutions. Again, if there's a challenge going on with the sponsor, a CRO maybe trying to protect the sponsors reputation. So I do think that better transparency is something that we can get to. And I also think, the initiatives and innovations that are available we do definitely need to look at those more. There are systems, like GPS, where the upload from EDC or even the upload of documents or the direct link to EDC allows the feed to be in real time so that when those payments need to happen, the sites can go into the system. They have transparency into what is deemed available based off the EDC configurations. They can select and choose from those things, which things they're ready to be paid for. That visibility is created within the tech and within the system. That is game changing for the sites because they know what the potential to be paid is. They get visibility into"Hey, I can see that this is waiting for an approval" or whatever the steps may be along the process. And you can different sponsors choose different processes, streamlining all the approvals where that's feasible. If it's an EDC and EDC has been updated and it can roll into the payment system, being able to allow that to happen fluently is a game changer because it ensures that those payments are getting to those sites in a much realer time than having to wait for a person, a body to go in and review the payments. And I've been in this industry for so long, I know so many people and so many different companies processing payments, and there are still companies out there that are using spreadsheets to process payments. There are still companies out there that are having to manually record what transpires into a system before it can be eligible for payment. And the likelihood of an error when you're doing things that manual is just profound. And then imagine being at the site or the doctor's office and you're dealing with all of these different types of scenarios with just trying to get paid and trying to mitigate that and ensure that you can still fund your staff, and afford to turn your lights on. I often wonder, how many sites close because you just can't afford to do anymore because we're not getting reimbursed. It's just a really tough place to be in. I also think again, where we can pay patients directly, and if it's a scenario that makes sense, that is so much better for the patient and for the site, because it takes a lot of that responsibility off of them. And we have options to do things like schedule patient travel for the patient. There's a term that Greenphire uses a lot of the patient neutral spend. I think that that is so important because, not only do these things cost the sites money, but imagine being extremely ill and needing to be on a study because you're dying or your child's dying and you found a study that you can participate in. But you can't afford to fly to California and pay for the airline tickets back and forth to attend the visits because it's the only area where this rare disease or, whatever it is study is, is housed. Getting to a place where we can pay for that travel up front, and that's the norm in the industry, and so the burden is off of the patient. I mean, that is where all of our ideals should be, right? Not only the slight impact, but that patient impact making it so they're not inconvenienced, and they're not in a scenario where they can't feed their kids because they're trying to save their life.

Jimmy Bechtel: 18:22

It's another great point. Several great points, Michelle. So as we begin to wrap things up here, reaching the end of our time, can you spend the last couple of minutes sharing a little bit about some of the initiatives, innovations, and maybe talk about some best practices to enhance some of those workflows. You alluded to several of them, but maybe, identify kind of put a pin in your really low hanging fruit or the ones that will might have some of the greatest impact that you've observed.

Michelle Ray: 18:53

Absolutely. So when I think of best practices, I do think a lot of process. And again, I think that tech is a lot of the solution for a lot of these. I think there's some things that we can do from a high level in every bit of this process. So, for your sites, if you're a site and you're struggling with payments, the first thing you can do is know your contracts. Know what your payment triggers are. If your payments are coming from a company that does not use a software that directly feeds from EDC and you're receiving a summary of what needs to be paid, do your best to match to that summary. And then you can go back and those things that weren't included in that, if they've had an error on their end, you can address those separately. That way you can get what money is available to you sooner rather than later. Also know your points of internal escalation for whoever you're paying company is. Don't just know your person who's assigned, but know who their next escalation point is, because at some point you may need it and you want to know it before you do. For the CROs and the sponsors, find a tool that prioritizes getting money to sites. I cannot stress this enough. There are so many antiquated systems and processes that are being used. These sites need money fast. Get the money to them. Find a tool that solutions these things for your sites. Because again, that even trickles down to your patients because if you're doing site reimbursements to patients, if the site doesn't have the money, that patient's out of money. Consider global limitations. We haven't even talked about the global impact of a lot of these things in this conversation, but not only are there regulations for each country and how payments should go out, but there are things like language barriers. Does the system or the company that you're using to process payment have a way to communicate in different languages so that the that the information they're receiving is legible to them because not everyone speaks English. Payment allocation requirements, that's so important. So, for an example, Poland, if there are different ways that you can process payments in Poland, making sure that whatever you're using accommodates the needs of those sites. And then even things as simple as Internet and power barriers. One of the other conversations I've had in my career that really resonated with me is I was talking to a project manager when I was in payments. And we would send the sites this spreadsheet of everything that they could possibly be paid for, trying to help them send invoices to us because we wanted to make it easier for them and faster. And the feedback I got for that was that a lot of sites don't even have Excel or know how to use Excel. And we were sending these massive, massive lists of everything that had occurred. Doing something as simple as putting it in a more understandable format, doing the pivot tables for them, creating the summaries for them so it was digestible. So impactful! So simple for me because I've got the external knowledge but definitely something that had a major impact on them. So, thinking about how we can make their lives easier and give them data in a more digestible format. And then the other thing that I think is a key takeaway is just because something is an audit finding does not mean that we have to completely reinvent and overcomplicate things to adjust that finding. Always ask the question, is it necessary? Is there a simpler way to do it? And what is the impact? If we ask those questions, then we're going to do a better job of ensuring our processes are tight enough where they're not over cumbersome.

Jimmy Bechtel: 22:32

Well, Michelle, that was excellent. I think there's so much for not only our site partners to understand here, but also some considerations for our sponsor and CRO partners to understand and think about. There are probably some things, I hope, that our listeners were able to jot down as key learnings and key thoughts as they went through this to maybe bring back to some of their teams and ask some of these impactful, important questions about, do we do this or do we not do this? Is this something we can do? Can we consider some of these paths? It's really what I hope that again, some of our partners are able to take away from this conversation. So thank you for sharing your knowledge in this space, again, so much to learn from and so many different paths and considerations is what I really liked it wasn't any one particular thing here that is kind of the end all be all solution. It's a lot of different things that we might tackle one at a time or in combination of to advance and improve the work that we're doing when it comes to site and payment. So again, thank you for being here and thank you for sharing your knowledge and experience here.

Michelle Ray: 23:34

Thank you, Jimmy. I really enjoyed it. I appreciate the opportunity.

Jimmy Bechtel: 23:37

As we wrap up, for those listening, don't forget to explore other site focused resources made available to you, like various publications and webinars on our website, myscrs.org. You'll also find there a wealth of content and information and details about participating in opportunities at upcoming SCRS Site Solutions Summits. Thank you again for listening, and until next time.