Beyond Numbers: Revolutionizing Clinical Trial Budgeting

Learn how dynamic benchmarks are shaping the future of clinical trial finances, offering adaptability, transparency, and stronger relationships between sponsors, CROs, and research sites. Shelley Douros, the Senior Director of Clinical Trial Financial Management, and Tina Mincher, the Director of Client Strategy at Medidata share their revolutionary CAP approach (Committed, Anticipated, and Projected) that is transforming how budgets are approached. Tune in to learn how to ensure fair market value and foster better collaboration with clinical research site partners.

Transcript

Jimmy Bechtel: 0:00

Greetings and thank you for being part of the Society for Clinical Research Sites on SCRS Talks. I'm your host, Jimmy Bechtel, the Vice President of Site Engagement. Get ready to dive into a space where we discuss pressing clinical research industry issues, celebrate noteworthy achievements, and foster a deeper connection with the clinical research community. This is the space to amplify voices and perspectives that shape the landscape of clinical research. Today, we have Shelley Douros, the Senior Director of Clinical Trial Financial Management. And Tina Mincher, the Director of Client Strategy in the clinical trial financial management group at Medidata. Thank you both for being with us here today to discuss the dynamics of clinical trial budgeting with some data backed benchmarks and some really interesting things that are being done in this space to improve this process at the clinical research sites. Shelley, Tina, it's great to have you. I'd love to start us off with some introductions from each of you, and I'll turn it over to you, Shelley, to kick us off.

Shelley Douros: 1:03

Hey Jimmy, thanks for having us. I'm really excited to join this podcast and to be able to talk about a lot of the innovation that we're going through and the work that we're doing to really not just serve our specific clients, but really help with the site and be able to get budgets off of the the main issue that's going on with sites right and be able to really make it more of a collaborative approach. A little bit about me, I work within the product and client strategy and data strategy team within clinical trial financial management at Medidata. I have worked in the industry on the site side. I've also worked at on the sponsor side, and I also worked at a another technology company that does similar stuff as to what we do, and throughout that time, it's been really focused on financial management and business operations. So, anything involving budgeting, forecasting, contracting, payments, that kind of thing. So, I'm excited to talk about what we're doing and thanks again for having me.

Jimmy Bechtel: 2:10

Thanks, Shelley. And Tina we'd love to learn a little bit more about you.

Tina Mincher: 2:14

Hello, Jimmy. As Shelley said, thank you for having us. Excited to be a part of this podcast. So I work obviously with Shelley in her team, clinical trial financial management as client strategy. And so a key part of my role is how we bring together the CTFM clients, sites, and industry to build trusting and long lasting relationships. So it's all about fostering kind of an established relationships to make sure that they're successful. Making sure every voice is heard will allow us to build impactful and efficient products and processes. And I previously worked with Shelley many moons ago. So we, we kind of go back a long way. And yeah, I've worked in the industry for 15 plus years now on benchmarking solutions and all about kind of customer services and how we can really foster a great relationship for our customers.

Jimmy Bechtel: 3:13

Excellent. Well, thank you both. It's really great to have you and I'm excited to talk about this. And Tina, I know that Medidata recently wrote an informative article on how to create smarter, more effective clinical trial budgets for the industry. So can you elaborate and tell us a little bit more how fair market value plays a role in determining costs in those investigator grants?

Tina Mincher: 3:36

Yeah, so we hear a lot about fair market value and the challenges that are faced when building budgets and the concept of fair market value is to make sure all costs and payments associated with a clinical trial are appropriate, fair and justifiable. Sounds easy saying it like that, but obviously it's very complex. So the benefit of current FMV is to protect sponsors and CROs from paying inappropriate fees. And as well, making sure sites are accurately reimbursed and the trial is not becoming a financial burden. This is something we are all familiar with hearing regarding sites facing financial challenges. And as we know, this is paramount to leading to a fractured and strained relationship. So as clinical trials evolve, so must the data that is used in benchmarking solutions. So using dynamic benchmarks will align with the ever changing research landscape that we know is very complex, becoming more complex, so it's really exciting to have a multi layer approach with the Committed, Anticipated and Projected data options.

Jimmy Bechtel: 4:53

That's great, Tina. Thank you. Shelley, did you have any perspectives to add to that as well?

Shelley Douros: 4:57

Yeah, so I think Tina really hit it. We did and have been doing a lot of work within client strategy with our Innovation Labs, Global Costing Task Force, engagements that we've had with with SCRS and your sites that you work with, to get feedback from clients, customers, sites to really understand where these pain points are and how we can move forward with ensuring that we're not getting market value. We're getting fair market value and understanding how this can differ between sponsors and CRO's and sites and how can we meet in the middle and really improve transparency and allow for that relationship to continue to grow and a lot of times the budgeting can be a hindrance and so how can we, on the financial side, bridge that gap and truly ensure that sites and sponsors are having fair market value budgets to start those negotiations and to start that relationship off in a really positive space. We've done that a lot with what we're lovingly calling CAP, which we can talk about a little bit more. And that is sort of the start and the Genesis of where we're going with our dynamic benchmarking.

Jimmy Bechtel: 6:22

Well, thank you both. It's really, really interesting. And I think it sounds like a step in the right direction to try to solve some of these problems. So I'm, I'm excited to dive a little bit more into this. Shelley, maybe. Help us understand one of the concepts that you all bring up within that, that publication, the CAP approach and in what ways does that approach what stands for Committed, Anticipated and projective help get at truly more fair market value and create that fair market value and maybe talk about some of the advantages that it offers over what we could call more traditional models.

Shelley Douros: 6:58

Yeah, so we've been calling it CAP. Like you said, it stands for Committed, Anticipated, and Projected. Committed is what you would traditionally see in Grants Manager or any product that you use that's similar, right? So the concept is historical information. So you would take historically Committed contracts, put this in a consortium of data, and then it basically spit that back out as what we have always called as fair market value. And that's great when we didn't have anything else. Right. But we needed a way to truly identify that Committed really isn't fair market value. It's market value. It's what you paid at the time you executed the contract. Right. So Anticipiated is really groundbreaking. Historically, we've seen some ways of people doing other ways of trying to come up with Anticipated, but they're really just adding a bit of inflation and things like this. And so we wanted to look at what we had in our system and where we started from and say, how can we make true fair market value? And that's where Anticipated came. We are looking at things like country ratios. We're looking at inflation. We're looking at third party data sources. We're still that Committed data. Those executed contracts is obviously still part of this as well. But exchange rates and then we're taking statistical models and creating accurate and current benchmarks so that you can say, okay, historically, my Committed was this and then Anticipated is what I think I can. I'm really going to pay going forward and then Projected is something that we're working on this year to implement, which is forward thinking, right? So if I am going to create a budget for a study that maybe isn't going to happen for a year or so, using benchmarks for today or Committed, which is historical, is not going to give you an accurate reflection of what you're going to pay and you don't want to send that to sites, right? Because that's not fair to send them something from data that was a year or so ago. So Projected will allow them to take what you haven't Committed, look at Anticipated and then actually add other modeling factors that are going to allow you to look this Projected cost so that when you go out the door, you feel confident in what you're going to be paying and sites feel confident in what they're being paid.

Jimmy Bechtel: 9:29

Thanks, Shelley. I think that last part there, of course, from my perspective is one of the most critical pieces of this. Is that sites feel confident in what they're going to be able to be paid. And I think this extra information, this extra data, this dynamic that you discussed, I think will be really, really important. Tina, I'll turn it over to you. Did you have any other perspective to add to that CAP approach?

Tina Mincher: 9:51

No, I think it's exactly like what you were saying there, Jimmy, from, from what Shelley had said for the Projected benchmarks it's also super important for sponsors and CROs to have the flexibility to see three, five years ahead, which then just kind of builds to that trust. There's that transparency, isn't there? So, utilizing, I think just only historical data may lead to outdated or inaccurate assessments. So, I think it's very exciting.

Jimmy Bechtel: 10:24

I couldn't agree more, Tina. Absolutely. Tina, let's talk a little bit more about how the dynamic benchmarks that you're integrating into this process and the publication differ from traditional or more static benchmarks and how technology plays in that some of that benchmarking.

Tina Mincher: 10:45

So dynamic benchmarks differ from traditional benchmarks, as Shelley had explained just before, as they allow for a more accurate and adaptable financial planning, which then allows for alignment into the ever changing research landscape. Clinical trials have adapted over time and the need for budgeting systems to evolve using current capabilities, such as AI is a must for a successful benchmarking solution. Benchmarks or dynamic benchmarks can significantly impact trials in several different ways, with accurate budgeting, what Shelley was just explaining there with the Committed and the, the Anticipated and Projected, and then improving site relationships. I mean, we would all be so happy to improve the relationship and make sure that the sites are getting what they need. Obviously cost management, it's identifying cost drivers, so it's just improving the management part and then the adaptability. So overall it will give a smoother financial kind of operation and better site relationship, which I think this is what we, we all would love to, to see.

Jimmy Bechtel: 12:05

I couldn't agree more, Tina. I really appreciate the site focus on this work and the emphasis in what the sites need because oftentimes we've seen over and over again. Solutions that are focused on budgets that are too sponsor or CRO centric. So it's great to hear that there's been such a strong emphasis in how this improves the relationship with the site and gets the site a deeper transparency and understanding into what's being done here. And I think those benchmarks and the approach that you all have come up with is absolutely part of this. So it's really, really great to hear. Shelley, I'll turn it back over to you. How do you envision the evolution of dynamic benchmarks and the technology being used to influence the future of our clinical trial budgeting.

Shelley Douros: 12:54

So I think that what we're doing right now really is the start of, I know we keep saying it, but really providing transparency between sites, CRO's, and sponsors and fostering, trust and collaboration between all the parties. I think that, not to plug SCRS, but I'm about to plug you guys. It's been always been one of my favorite times is to go to these different meetings that you guys have and going to the summit and being able to hear from the sites, especially when I was on the sponsor side and again on the technology side, because hearing the sites say things like. We want to see itemized budgets, and I know that back in the day, we stopped doing that because we thought giving itemized budgets was too much, and it was putting a burden on the sites. However, the sites are saying the exact opposite, and so it was important that we take that type of information. And translate it right into, Well, how can we make our technology work for both sides? Because ultimately, having a good relationship, it helps the sponsors that helps the sites, but it helps the patients, right? And we don't need financial constraints to be what causes delays in patients being able to get care. And that is truly one of the things that we focused on. And by taking technology and saying, How can we? Talking about finances and budgeting is always not the most exciting topic. However, it is the one that makes a lot of impact and could cause things to halt or could cause things to move forward, right? And so we're taking our technology to say, how can we get you financial numbers and applications that help you flow through this process effectively? In a fair way? To continue to improve those relationships, to allow you to have accurate budgets, improve the site relationships with cost management, adaptability, and overall, just being able to say if you're utilizing something that's giving you dynamic benchmarks, you can trust immediately when you get a budget from Sponsor X that you know that it's going to be coming from a fair place, so you want to pick up that budget, you want to get it executed, and we want to be able to help you move forward and get to patient care and worry less about financial implications and more about what we're really here for, which is helping the patients and moving forward with healthcare.

Jimmy Bechtel: 15:31

That's excellent, Shelley. I can't tell you how much I appreciate that perspective. And I am excited to see this resource in action on some of our clinical trials. So it will be great to come back to conversations like this and explore the outcomes of what's being done again, going back to that benchmarking. Let's see how much this was able to improve this process. And see how we can bring that information to the sites in forums like this. Tina, did you have any perspectives on the future of clinical trial budgeting and how tools like this will continue to improve what we're doing here?

Tina Mincher: 16:08

I think transparency was the biggest theme. And we hear this word all the time. Don't we? If we could just have more transparency. With all of the research that we have, we have done with the innovation labs that Shelley had said with the global costing task force that we have, and then with the wonderful SCRS SAG that we were able to be a part of, the biggest theme always came out to be transparency. And I think to be able to be a part of a solution. Conversations, discussions, where we can actually execute on making the relationships and the sites kind of life a little bit easier in the complexities of what they have to handle. Of course, we support sponsor CROs, but I think if we can just continue to make sure and execute that we do get the transparency and get the site voice heard, I think we can smile and feel like we've done a good job.

Jimmy Bechtel: 17:12

That's excellent. And I think a really wonderful place for us to end our conversation today. Thank you both for your contributions to this work. Thank you both as well on behalf of the research sites for the emphasis on how this helps the work that they do. I can't tell you how much. This will be appreciated when we start to see improvements at the site level in executing our clinical trial budget. So Shelley, Tina, again, thank you for being with us today.

Shelley Douros: 17:40

Thanks for having us. Appreciate it. Thanks for letting us talk about this.

Tina Mincher: 17:45

Thank you so much.

Jimmy Bechtel: 17:47

As we wrap up, don't forget to explore more site focused resources on our website, myscrs.org. You'll find a wealth of content and publications, plus the opportunity to save your spot for upcoming webinars and SCRS Site Solutions Summit being held throughout the year. Thank you for tuning in, and we can't wait to have you back for more enriching content. Until next time.