Site Landscape Review: Today's Top Site Challenges

In this episode, SCRS takes a deep dive into some of the most pressing challenges that clinical trial sites are confronting in 2025. Join us as we explore the current state of site payments, workforce trends, diverse recruitment, and the growing role of technology-enabled trials. We’ll unpack the reasons behind these challenges, from payment terms and reimbursement struggles to the complexities of diversity and technology adoption. Tune in as we discuss how to break through these barriers and create a more inclusive, sustainable and innovative future for clinical trials.

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 insights, trends, and innovations shaping clinical research today. I'm Jimmy Bechtel, the Vice President of Site Engagement with the Society, and today I'm joined by a couple of my colleagues at SCRS, Karri Venn and Mike Pierre, here to talk about some of the data that we gathered in this year's Site Landscape Survey today and how it goes to underscore some of the challenges that the clinical research sites are facing. We wanted to take some time to dive into some of those, address them, and get some additional perspective. So, Karri, Mike, thank you for being here today. Really, really excited to dive into this special topic. And I want to start us off by talking about the challenges in study budgets. We saw in the 2024 site landscape survey, Mike, that 72 percent of sites prefer monthly payments, but only 38 percent of payments ultimately are monthly. In fact, nearly half, just about 47 percent of sponsors report preferring quarterly payments. So this isn't something new. This is something that we've talked about for a long time. So in your eyes, why, after all this time and discussion, do we still see this disconnect in monthly and quarterly payments between sites and sponsors and CROs?

Michael Pierre: 1:22

Well, the quarterly payments have been going on before I even got into research in the early 2000s. And with the site network I was working with Christine Pierre, one of the first things that we did was, and I think the one thing that they pushed on was trying to reduce that to monthly, and that was 20 years ago, and it's still happening. So, what I was told, and I haven't heard anything to the contrary was that the original payment schedules were quarterly because hospitals were doing the bulk of the research. And I think anecdotally, they would say that the hospitals consider themselves as contributing to the research process. So, they accepted the quarterly payment terms, and they also weren't really tracking it that much. It was just something they did as part of being in healthcare. Then the site network started coming along and trying to push that needle towards monthly and have been struggling with it ever since. And I believe it's a holdover from that. And the reason it still remains, I would suspect, would be that if sites keep accepting quarterly payments, they're going to continue to show up in contracts. And I haven't seen why they would change that if that's still the accepted and popular payment method. If sites would decline it or not take any trials that paid quarterly, then it would stop immediately. If you're selling something and no one wants to buy it, you discontinue the product.

Karri Venn: 2:42

Michael, just add to that. I think it still comes down to, lack of a professionalized site, but I also think there's definitely some pharma and or biotech or small pharma that are still deploying systems that can't quite enable this variety of payment system models. And you know, really just challenge those companies to upgrade their systems. And again, for the smaller sites to really take to heart the impact to their cash flow if they're going down the pathway of quarterly payments they really have to change that behavior.

Michael Pierre: 3:12

Yeah, Karri. It may also reflect the payment schedule from the sponsor to the cro in the case where the cro is the payer and some sponsors, the smaller ones, might not have a constant stream of income. They might be looking for people to invest as the trial is going on.

Jimmy Bechtel: 3:28

Great points. And a lot of what I'm hearing Mike and Karri is that it's an ingrained practice that's been going on for a long time and it's tough to change, which we've seen be an issue in the industry. And kudos to the companies that have made that switch and have made that the norm for them. It would be great to see some of those other companies get on board and if a handful of them have been able to do it, it's the other hand, but I guess to Mike's point, word to the sites, if you want monthly payments, you push harder for those monthly payments. And that's when we really start to see the needle shifting. Cause as long as there are sites out there that are accepting quarterly, it's tough to justify that need amongst other sites.

Michael Pierre: 4:05

Yeah. And I haven't seen the latest statistics on this, but when I was looking into it, some would report 68 percent, up to 75 percent of investigators do one trial and never do another one. So there's always this constant flow of investigators that accept those budgets. And as a CRO many years ago, stood on stage at ACRP and said, if we send a budget out and 70 percent of them come back with no changes, then we assume we offered a fair budget and payment schedule.

Jimmy Bechtel: 4:34

Yeah, it makes sense. And it does paint a really interesting picture for the industry when you have that kind of turnover and a lot of, New investigators or new research sites or inexperienced ones that don't know the difference just accept what comes across their desk even if it might be in long term detrimental to their existence it's a contributing factor to that 70 percent we don't know for sure. It is an interesting statistic Continuing to speak to study budgets. Uh, A R continues to also be a big challenge for sites. 30 percent of them report that at least a third of their AR is more than 90 days old. And coupled with these infrequent payment terms, which is probably the foundation of that statistic. How does that ultimately impact sites? from a research site perspective, karri, what do we start to see happen when these, ARs start to get over 90 days old, over 120, et cetera?

Karri Venn: 5:26

It's just compounding the problem of being paid quarterly, right? So if you're paying quarterly, waiting for your payments, a good portion of them aren't even captured in that quarterly payment. And then on top of that, you have your invoices not even being paid or outdated. It adds further insult to the cash flow problems that sites have. I think there's a ton of issues surrounding this. And this is not just, on the sponsors. and CRO side. This is also on the site side. We in the site payment initiative group. We had a lot of discussion surrounding what we could do. I think the best we can do is continue to educate sites on best practices, and that comes back to the same challenge. If you don't have proper accounting or finance personnel to best support those practices in invoicing submission and follow up on payments, that will always be an issue. So whoever is doing it at the site has to take pride and understand what's required. On the flip side, the variety of issues that that particular individual faces, somewhat similar to coordinators, having to understand every sponsor and or CRO requires a different invoicing practice, and so you have to kind of learn what what information is needed? Where do I need to put it? What system do I need to deploy? So sometimes just the lack of clarity, the complexity of that, adds further insult. the additional problem we're all facing is this wide turnover and workload being experienced by some companies, you get the communication gaps and ultimately no one's responding to that request for payment, and honestly, there's some bad players out there, you know, maybe a CRO is waiting for the sponsor to pay. Sponsors not paying, they're withholding their funds to pay you. There's so many barriers in this particular area. It's such an important area for sites to focus on because most sites are leaving money on the table. either they're not invoicing, and if they are invoicing, there's challenges with just the follow up on being paid, you have to be on top of it, and you really have to have dedicated personnel to focus on this, Mike, I know this is an area that you also specialized in with your previous company too.

Michael Pierre: 7:31

Yeah, another thing that contributes is the quarterly payments, but it's also the withholding because if you log a visit on January 1st and 10 percent of that visit is withheld for 2 years till the end of the trial, the bank would not even recognize that as income. They say you're never getting that money. And an additional problem this puts on the sites is that if you are beyond 90 days on your receivables, and the sponsor pulls the trial and goes out of business, the site is probably the last party to know that that took place. They'll make a phone call and they'll say, Oh, we'll get right back to you. And when you finally learn that the sponsors hold up stakes, everybody else has gone in and gotten what they can get, and there's nothing left for the site. You'll lose all that money. So that's why I believe sites should push to get zero withholding and quicker payments And we saw that happened a great deal in 2008, where sites were losing a hundred thousand dollars because they didn't know the sponsor was out of business and the sponsor doesn't have a responsibility to tell you. The IRS is going to make sure they get paid first and then the banks and then anybody with a guarantee of payment. And then the sites are going to get a portion of what's left if they get in early enough to get it.

Karri Venn: 8:43

Totally agree with you, Mike. There's the odd experience we've all had probably where the company, went out of business and we ultimately pay the price for it. But if you're noticing that there's a lack of payment and or a delay to payment, we would start to restrict monitors coming into the office. You have to deploy some tactics to protect yourselves to at least get some money. So you do have to monitor that AR frequency in which you're being paid, whether that be for visits and or the invoiceables.

Jimmy Bechtel: 9:09

You guys make some really, really great points especially around the couple of things. It's, it's two sides, right? It's the sponsors and CROs. We know the, the payment issues compound this challenge, but there's a lot of resourcing and effort that needs to go in at the site level that a lot of sites probably don't understand, particularly when they go into it because we see all the time the people that Are in clinical research are clinicians, right? They're investigators. They're providers. They're doctors. They're nurses. Et cetera, et cetera. They're, they're these people that are tied to the clinic and they're tied to the patient. So they don't always think of what we'll call best business practices. And it's really challenging when it's a small business on a contractual relationship with a mega corporation that they're trying to organize their payments with, and it can compound a lot of these issues. So I guess the moral of the story there, what I take away from this, and I want our listeners to understand is that getting your resources appropriately allocated so that you can stay on top of your AR and AP and when payments are coming in and invoices is an essential aspect to keeping yourself in business because=Arguably it's a lot harder than it looks when we talk about, the agreements we have in place with the sponsors and CROs.

Karri Venn: 10:26

Absolutely. And it comes back to Michael's, previous stat, which was 70 percent of the physicians do one and done. That's a particular site that has one coordinator. I mean, honestly, how are they actually figuring out how to read these contracts and budgets and invoicing on top of the actual coordinating work that they have to do. and make

Jimmy Bechtel: 10:42

sure that they're safe. Yeah, absolutely. Well, on a brighter side, I know we talked a little bit of doom and gloom here with some of the challenges we're facing, but on on the brighter note, sites when it comes to workforce seem to be slightly and slowly recovering when we look at that perspective, we saw on the landscape that 41 percent actually increased their workforce by somewhere between one and 10%. Um, We know another large percentage of those sites kind of remained stagnant and only a small portion of sites, it was something less than 20 percent of sites somewhere around 20%, saw a decrease in their workforce, for a variety of different reasons. It might've been a layoff. It might've been voluntary leave, et cetera, et cetera. So again, it seems to be that we're moving in the right direction. And I want to ask you, Karri, you've been with sites recently and you're working with a lot of other sites in the industry. What has changed and do you start to see this as a little bit of a sign of recovery?

Karri Venn: 11:40

Okay. So here's my positive and negative answer. So, sorry, I'm going to have a little bit of doom here, but, uh, the positive, let's focus on that first. I do believe there's been tremendous work and again, applaud SCRS for being a part of that. To actually advocate to the sites. part of the education of sites. What are the types of salaries you should be paying your people? What are the types of benefit packages you could put together? What are some of the retention strategies? If you can't maybe afford that salary, what are the different retention strategies that you can deploy that will actually have positive impacts in retaining your staff? So there's been a lot of work discussed over the last few years, and I believe that's had some positive impact on retaining the staff at the sites. On the flip side, what I do worry is happening here, a big part of the who is hiring the coordinators at the sites were Big Pharma, Big Pharma, And ultimately, we're starting to see a shift in their workforce and some potential layoffs and or right sizing, if you will. And I think that obviously in turn, they're not hiring our coordinators if they're having impact. And my worry is the trickle down effect of studies being delayed, studies being canceled, the right sizing of the big pharma and or CROs, less studies, potentially that you're going to have some correction that needs to happen at the site side, especially the sites that have kind of really inflated their staff to manage the years past workload. They may have to do some kind of further termination and or layoffs themselves, which breaks my heart. You just don't want to see that. So we really need to figure out how to ensure that we teach our sites to plan for contingencies and risk mitigate and to do all these things to ensure site sustainability so they can keep their staff. I think that's where my worry, goes with potentially some of the impact of the workforce, at the sites. But let's stick with the positive. I think there's been a lot of work with educating the sites on what they need to do, correcting the salaries. You know, inflation's really pushed, the sites to adjust the salaries, and I think that's really helped a lot. But, I think time will tell. It'll be a really interesting year to see if these study cancellations and delays have further impact into 2025.

Jimmy Bechtel: 13:51

I agree, Karri. it is interesting. Anyone who's attuned to the industry can see just what you're saying. there have been some sites, networks and organizations out there that have had to take things in the different direction. And it's likely a result of a lot of what you spoke to, but I too am interested to see what the data is going to show us this next year, as a result of the movement we're seeing at the sponsor and CRO level and at the site network level. I want to also then shift gears into the technology landscape. Every year we do ask some questions in anticipation of our June SCRS West conference, which focuses on clinical innovation and technology. it has its own special landscape, but still aligned with those budgetary challenges just in the technology space. We know that reimbursement for technology related costs remains the highest priority issue at the site. 62 percent of sites report stronger budgets are needed to continue to make technology enabled trials work. So Mike, when we talk about reimbursement for technology enabled trials and some of these elements with, with innovation and I will call it newness in clinical studies. what does that mean exactly? Can you, expand on that?

Michael Pierre: 15:03

Well, the issue with technology is sites, and I speak as someone who has done this, implementing An E source system for a large site network. And you can see from our landscape data they are willing and actually eager to engage in all this new type of technology. they believe in the efficiency of it and how the end result will be cleaner faster and better. And so they are very eager to take on any new technology that comes along. But sites, as far as I know, are not involved in the development of technology outside of possibly some site advocacy groups or if they do some internal work. So what happens is the technology occurs first, and then the sites figure out how to use it effectively. As it's going, so they start in, well, let's even back up. They'll say, I'm going to implement a new e source system. they spend a lot of time trying to find one that works best for them and their sites. they're not computer programmers or anything. They're doctors and health care people, which have a whole different perspective than software designers. So they, they get their new technology, they pick one, and that's when they start figuring out what it doesn't do. then they have to adjust. So now the site is enrolling. Well, first they got the software, then they start training everybody. And that takes, much longer than anyone ever thought. And then when you have turnover at your site, now you've got to teach all these new people the stuff that the last person you trained. And so there's this constant churn of sites, training people for this new technology. And then they're also managing upward towards that tech company to say, your software doesn't do this. How do we solve this problem? How do we do that? And now The software provider is now. adjusting their product and it's slow. It doesn't happen right away. It can take months or years if anyone that's ever done it will see. So they're learning how to do it. They're managing upward to the vendor and they're enrolling subject at the same time. And they know it's a lot of work and resources and time and they can't quantify it. they just know it's a lot. They have, their training records. which can prove, everybody had to take this training. It was an hour, but they are unable and don't have the resources to capture the amount of time it's really taking it. And as Karri mentioned before, most of these sites are a couple of doctors and a couple of coordinators. they don't have the time and any way To quantify this labor into something with a bottom line, like a dollar,

Karri Venn: 17:33

figure. So Mike, would even add, there's an actual, there's an actual cost for some of the site owned tech on top of it too, right? So you got to pay for that. Then the people to manage it is the other burden that you're talking about. But, I would also push further that, my mantra for 2025 is get back to basics. seeing some of these trials that deploy 10 to 12 different technology systems, where a coordinator could manage that trial. You now need two coordinators to manage that same visit and or trial. And to me, that's the extra burden and cost is the additional support that's needed to actually roll out. I just don't see that the sum of the tech that's been deployed has really improved that efficiency, which is what we're all trying to get to. And I believe there will be, but I think it's just how it's being deployed right now. And That they're all not connected or integrated, different systems. It, it's very complex and it takes a lot more people to basically, manage the protocol than it once did before. So wherever we can keep back to basics we need to be thoughtful as we move forward.

Michael Pierre: 18:35

Yes. And like you mentioned, there are the costs in the budget that the vendor is charging them for to start a new study. It's X amount of dollars. Every time you add a patient or a subject or a trial. They all have different terms and these are real costs and the sponsors on their side can't just approve whatever comes across their desk because they get audited all the time And it's very difficult for them to come up with a new Charge to put in your budget. They would like to, I'm sure if you ask every sponsor at the summit, would you like the sites to be able to cover these charges? Yes, but they can't because they can't. We can't just say, hey, this costs 2000 for the vendor to start this trial And sponsors pay on on tradition and things you expect to see in a budget. they don't want to get audited and have some new charge in there for 8, 000 because they're going to have to explain why did you give this site that? And not the other 58 sites in your trial. So it's difficult for them. And I think it's going to take the same amount of time as everything else has been going on for years, where the sites constantly push to get little, little amounts and eventually they become traditional and expected. I think technology is going to be the same way.

Jimmy Bechtel: 19:47

Well and we know Mike and Karri, there's aspects of technology to that are sort of ancillary to it that do add to this. We'll call it costs that drive it up and make it misaligned with what the expectation is and what the sites are able to deliver, right? Things like training. We know training is a huge burden for sites when it comes to this technology for a variety of different reasons. But the amount of time, the sheer amount, the modality of the training is challenging and so is the technology support and the tech support that goes along with that when something does go wrong, not only at the site side, but also on the patient side. These things are all time consuming tasks that need to be paid for. That are not always reimbursed or adequately resourced from the sponsor and CRO side and ergo, the site side and it's one of those things like you had both mentioned, it's tough when we're all trying some of this stuff out for the 1st time to truly know what the costs are associated with it, even at the sponsor and CRO level. They're not experts at what's going to cost the site and take up their time. The sites are. So it's the site's responsibility to do it. Push that information to your point, Mike, back up the chain to the sponsors and CROs to say, Hey, this is how much this is costing me. It's then the sponsor and CROs duty and responsibility out of building a respectful relationship to provide reimbursement for those costs when they are justified and realized at the site level.

Michael Pierre: 21:16

And another issue you've raised is that paper and pen never crash. Technology, especially when you enrolled, you're going to start your flu vaccine trial and patients are lined up at five a. m. That software, that's when it's going to crash. And the chaos that causes is, I really, I don't even know how to calculate the cost of it. And no one's going to pay it. The site's going to eat it. The vendor's going to say, hey, we promised you a 99 percent non crash rate. Too bad your 1 percent happened the day you had 200 people waiting for their flu shot. there's that kind of technology, that side of it to the dark side, where it might not be there because now it's not just the technology. You also have the internet and whatever your local network is. And all that it just creates a lot of uncertainty. The other time it works fine, but it's that time when it doesn't, it gets super expensive for the site. And so they have to. deal with all that in real time and just say, Oh, well, I guess. Crisis mitigation mode,

Jimmy Bechtel: 22:15

Exactly. Well, I want to dive into the training a little bit, Karri. And I know one of the highest priorities for our industry partners is resolving the misalignment that exists with training. We, we kind of put a pin in the fact that it is universally accepted that there needs to be work here. So what can be done here? What, what kinds of things can we do to work on The challenges that exist in the training.

Karri Venn: 22:37

You are teeing me up for one of SCRS's missions for 2025. So you're going to hear a lot of marketing and announcements and, discussions with pharma and a CRO for really cutting 25 and 2025, that's what we're going to be naming this, but uh, sites really need to come together to advocate that we need to reduce the training burden by at least 25%. And ultimately. I'm not going to give you the answer on what that might be. there's a lot of redundant training, a lot of training that's being requested that's not needed. I think now there's a lot of sites that have staff by tasks, not the traditional coordinator doing it all. So maybe only doing task oriented training. I think also adults, you know, we're certainly in the mindset of, less training, short stints. It's easier to absorb and understand this whole adult learning mechanism for greatest impact on training and learning. I think those philosophies have to be brought forward, taking the time that a site waits to start up a study. How can we institute training at the right time? So we're Utilizing the best practices around that, as opposed to kind of hurry up and do everything and everything at the last minute. But I'm super excited about this one. We're gonna have a working committee to come together to really brainstorm, provide suggestions. We're really hoping that some sponsors and CROs will put a stake in it and commit to making this change for 2025 and start to adjust how they roll out their site initiation visits or their investigator meetings or just the regular training requirements for accepting a person to be delegated on a trial. So this is going to be a fun 1 I think, and a really important 1, because ultimately, I mean, sites asked to be paid for training, but if you can't be paid for training at least cut the time that you require my staff to be trained because I have to tell you it's incredibly costly, especially if you have, for instance, physicians that you pay on an hourly rate, and you have to think about that in a site or a sponsor is requiring you to to train 8 to 12 hours for a trial and you want multiple backups. There's just a lot of money going out from the site perspective that's creating problems with cash flow. so yeah, this is definitely something that has to change. We have to correct this for sure.

Jimmy Bechtel: 24:49

I couldn't agree more, Karri, and I'm glad to be working on something like this and rallying the troops, around the reduction in the amount of training that we're doing because, like you said, it doesn't seem like we're getting funding for the training as it stands today, so let's work to reduce it. I want to shift gears and talk a little bit about diversity. We know that there continue to remain a lot of ambiguity and uncertainty around how diversity impacts our trials. We see that most sites actually report that the guidance from sponsors and CROs. is what's needed and remains a little unclear on what the expectations are for their conduct of clinical trials as it pertains to what that means in terms of diversity, equity, and inclusion for that study, where we talk about diversity action plans and all the requirements from our regulatory agencies. But Karri, how do we start to chip away at this how do we start to make a difference around that ambiguity and that uncertainty or the amount of work that is unclear at the site level.

Karri Venn: 25:51

It's interesting cause I would actually argue a lot of sites are already doing the work. It may be natural and innate with how that particular site is set up and or the community in which they serve. But, let's speak to a lot of the sites that are still unclear. one of the things I would strongly encourage that they do is, sCRS has rolled out the updated. And then there's a um, uh, DSAT questionnaire, which guides you into understanding the areas you might need to focus on improving whether it be a community engagement and or marketing the type of stock images you use how you are actually hiring your employees and or your investigators. There's a lot of definitely good practices and what I'm really excited about is that After the DSAT is deployed and all the data is collected, we're going to be creating a toolkit. And a toolkit is really just providing those resources to sites so that they don't have to go and search for themselves to find the best resources out there. Create a repository of those resources so that they can tap into to really continue to educate on what their own diversity plan should be. And the action items they need to pursue improvement in enrollment and the diversity of their community. But, on the flip side, we still need to continue to advocate. It does cost money to do some of these initiatives, to hire some of these staff to do kind of, let's call it outreach and engagement with the community. I'm just on simply educating them about that, you know, the positives above clinical research participation, but there is some cost mechanism there. Again, we're talking about the site small site may not have cash flow already because we've got quarterly payments, withholding and invoices not paid. So we need some some support there. And so I'm hoping that, the sponsors and CROs can find ways. And what I'm learning is that each sponsor has different pockets of money that exist in different departments. You have to figure out what department it is. Try to access it. And, just to continue to ask the question, make the request for support I'm even seeing some sponsors potentially deploy staff to actually go into those communities and work alongside the site to support it. So we have to continue the conversation. We have to encourage transparency. advocate for kind of the metrics and the data sharing on what's working, what's not working. What I believe is every site is not created equal. And there is a strategy that site has to deploy. As an example, I could be embedded in a physician clinic. Is that clinic? In their practice, actually gathering diversity data where you could query and do some direct outreach to particular patients that are needed for a trial to meet that diversity enrollment. So there's definitely different ways in which you need to deploy tactics, and it's really understanding your own tactics that you need to deploy and how you can advocate for the funding to do it.

Jimmy Bechtel: 28:33

It's exactly right, Karri. It's interesting because you hit the nail on the head here. It's not that the sites aren't trying to do this. A lot of sites to your point have really great plans and they are doing this They know why it's good. And so they're doing their own thing. I think where the misalignment exists, Making sure that what they're doing aligns with what the sponsors and CROs want because I think that's where the ambiguity is. So thank you for, honing in on the fact that we need to remain transparent. I think there's an onus on the sponsors and CROs To continue to communicate with the sites on what those expectations are as they figure them out. I realized that some sponsors and CROs are still doing that. They're still trying to figure that out, what that means for them. But as we do this involving the sites and those decisions and communicating that down to them, I think we'll go a long way for making sure that we're successful in doing what we're aiming to do. With this diversity, equity, inclusion work, and that is to bring medicines to patients that represent the patient populations that are most affected by a given therapeutic area or disease state. So thank you for making some of those points. I want to Mike circle back to our common thread here around budgets, but this time in the context of diversity, equity, inclusions, we see that sites. Are often requesting budgetary items related to enabling diversity, yet it's not commonly reimbursed. We have data through the site landscape that tells us they are asking for this. They're just not getting a lot of the funding there. So what can we do to address when a site's asking for something, but they're not necessarily getting the money here.

Michael Pierre: 30:10

Well, this is a tough one. From my perspective, when a site is putting something into a budget, and it's something the sponsor has not seen or paid for before that makes it more difficult to Approve. Now, I don't know what sites are requesting regarding diversity funding. I don't know if what they're requesting is reasonable or outrageous. But it may be outside of what's approvable. if sites have been requesting monthly payments and 0 hold back for 20 years. I hope it's not going to be the case, but diversity funding may be on that same track. So they're going to approve little things at a time. I would suspect that the sponsors want to see what the sites can do. I mean, typically, in a trial, I think it's 50 percent of sites and on any trial will enroll zero or one subject. So, half the sites aren't doing anything. It's that next 50 percent that are doing most of the work and probably the top 10 percent are doing almost all of it. And so the sponsors want to see what the sites can do because if they're going to fund recruitment they're already pretty tight with that money. They just don't hand out recruitment money. And now you're saying to the sponsor, now we want you to capture what we've been explaining to you for the last 10 years is the hardest group of subjects to enroll. And now the sponsor, They don't know what they're going to do, so they're going to let the sites do whatever they can to enroll that, to see what they'll do that works. And so this may be, another testing ground, probably just like the technology fees. Everyone's going to see who does things right, and then that's where the money's going to go. So I'm sure the sponsors are hesitant to Fund or lose that recruitment money trying to enroll subjects that are already the hardest to find.

Karri Venn: 31:52

Here's the catch 22 michael. So the sites, you know, you said the 10 that are doing well, they're already doing it probably out of their own pocket So we have to kind of flip it. And I've always tried to say, as a sponsor, why wouldn't you celebrate the sites that are actually doing the work and continue to best support them? But sometimes they look at that budget and say, this is what I have to work with across the board, no matter what, that site that doesn't enroll versus the site that enrolls, Maybe 200 percent of their allotment, right? So, you have to really challenge sponsors and pharmacists. Say, let's look at each site, not treat them equal. And let's try to support the sites that actually have created the systems and or the infrastructure and or the support to basically help them continue to do a great job at enrollment, right? As opposed to it being that hidden cost or the cost of doing business mentality. Let's continue to elevate those particular sites. Well, at the same time, bring on new sites and best support them. That might be, them providing resources to that particular site to get them going, if you will. Cause there is that kind of effort to professionalize site. You have to, build up enough revenue to continue to build the resources, right? So it doesn't happen just at the starting gate for sure.

Michael Pierre: 33:01

Yeah. our diversity summit and our global summit, there's, undeniably complete support for this initiative of D. E. and I. But now everyone's trying to figure out how to do it. it's not that the enthusiasm is not there. we're in the learning period of how this is going to be accomplished.

Jimmy Bechtel: 33:18

It's exactly right, Mike. And you drew great ties back to the technology. We're all kind of in it together trying to figure it out. It's just goes back to the points that we've been making. There's responsibility of the site around being able to gather and justify and effectively cost the work that they're doing out. But it's also the responsibility Of the sponsor and CRO in the relationship to ultimately then understand these are true and real costs at the site level and pay for those true and real costs. Karri, what can we do outside of those budgetary items to work towards those inclusive trials? Is there anything we might be able to do without these large swaths of funding? And how do we, work around that funding challenge together?

Karri Venn: 34:02

Definitely. It's not just the funding issue. Unfortunately, we're still creating protocols that have restrictive inclusion exclusion criteria that does discriminate. I think if you have a complex or high protocol burden from a visit load and our expectations of what's required in those visits that can also make it challenging. You know, getting to the point where if you don't offer that kind of hybrid approach, if you will, being able to recruit for maybe areas where people are a bit further. So we need to still continue to work towards the variability of offering of how we conduct that protocol. Ensuring that protocols are simpler. My worry is that some of these protocols are getting more complex, so that definitely worries me. We have to get to a broader based inclusion exclusion criteria to open those doors Also, I would encourage sufficient reimbursement. One of the site payment initiatives that we're going to be working through and be working on 2025 for SCRS is the specifics on what is considered fair to pay A participant to come in do the visit and the work required in between visits. Let's call it an eDiary, if you will. And so I'd love to get ethics on board and say these are fair, equitable reimbursement and or payments to participate in clinical trials. And I believe that will better support people being able to, leave work and actually join the trial. So we have to continue to advocate for that. Also the advocating that was done on the taxation burden, we have to get these laws deployed where that is not going to be the case, especially for the U. S., where, participants with a higher, amount that they're receiving may have to pay tax on that amount, which to me is just ludicrous. So there's a lot of advocating that needs to happen in this area, whether it be by protocol design what. We're paying the patients and ensuring that the government isn't taking, tax from that particular study participant then I think just, selecting the right sites, we are learning that sites aren't really good about marketing themselves and highlighting what they're doing already so that, they can be selected. And, every pharma or CRO is ensuring that we have new sites coming to this industry. So that gets back to the toolkit and resources that we can continue to educate and support these sites that are newer to the industry so that we have good success all around.

Jimmy Bechtel: 36:13

Well, Karri, Mike, I think that's a great place for us to end our conversation today. Thank you so much for your time and for sharing your insights and adding some additional context around some of the challenges we see at the site level. I hope that our site partners, as well as our sponsor and CRO partners that may have been listening, were able to glean some insights that they might consider bringing back to some of their colleagues within their organizations on what we can do to continue to advance CRO. That's the work that needs to be done around these challenges. So thank you both for your time today. I'd also like to make sure that everyone listening doesn't forget to explore some of our other site focused resources. A lot of them covering topics we discussed today, like our podcasts and our publications on our website, my scrs. org. All of our other opportunities as well, like our webinars and our summits. where you'll find a wealth of knowledge and content and chances to engage on discussions like what we did here today. I'd like to again, thank you all for listening, tuning in and until next time.