Strengthening Global Research: Insights from TSTrials

Rani Khetarpal, Executive Lead at TSTrials, discusses their recent collaboration with SCRS as a Global Impact Partner. TSTrials, a South American site management organization, specializes in infectious disease, oncology, and rare disease trials. Rani highlights their success in patient retention through innovative navigation programs and their vision to position South America as a key destination for global 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 Rani Keterpal, the Executive Lead of Global Development and Partnerships with TSTrials, here to share with us a little bit more about their exciting recent joining of the SCRS global impact partnership program. Rani, it's great to have you, really excited that TSTrials has joined the global impact partnership program and excited for our listeners to learn a little bit more about you and what TSTrials does. So if you wouldn't mind before we jump into some of our questions, it'd be great to learn a little bit more about you.

Rani Khetarpal: 0:48

Sure. And thanks for having me, Jimmy, really appreciate the opportunity to be here today. So I come from the sponsor side of the business. Actually, I spent a lot of years in pharmaceuticals, biotech, life sciences about five, if I can recollect correctly different organizations mostly all on the commercial side, my latest role was with Moderna. I was vice president of strategic partnerships with Moderna and I'm really excited to now have jumped into the other side of things on the site side and it's been a really fantastic journey for me to now be working on the other side of the table and making sure trials get to where they need to go.

Jimmy Bechtel: 1:30

That's awesome, Rani. And would you mind sharing a little bit about TSTrials as well? Maybe what some of what you all do and some of your areas of speciality?

Rani Khetarpal: 1:38

Of course. Yes. So TSTrials, which is actually known as I trials in their part of the world, which they are focused in Latin America, specifically South America. TSTrials is a site management organization whose network spans to four different countries, specifically Argentina, Brazil, Chile, and Uruguay and they are focused on large scale trials specifically around infectious disease and vaccines. However given the successes they've had in years past, they've been able to expand their therapeutic area of focus to include oncology, rare disease, ophthalmology, dermatology. So pretty much the entire gamut. They've got capabilities around. They've done a lot in a very short amount of time. And what was really interesting to me as I started to engage with them and learn more about their capabilities as I was going through my process with them is just the ability to really accelerate trials and essentially drive the quality results that are needed within the clinical trial space which obviously we know have a tremendous amount of KPIs, but the founders of TSTrials are all scientists, researchers and physicians who were trained in the U. S. So part of their success is being able to build SOPs and processes that align with U. S. Standards. But in an area of the world where the ability to accelerate the trial process is rampant. So a really neat organization when you start getting into the depths of it.

Jimmy Bechtel: 3:13

That's excellent, Rani. And thank you. Its awesome to learn about various new partners and some of the unique things that they're doing in the clinical trial execution space. So, Rani, one of the questions that we always like to start off these new G. I. P. Podcast interview conversations with is about the inspiration that TSTrials had to become an SCRS global impact partner, and maybe a little bit of how this specifically aligns with your organization's goals.

Rani Khetarpal: 3:44

Yeah, absolutely. We were really impressed with what SCRS has built with the GIP, the global impact partner program. I know when I started to learn more about it there was just a lot of opportunity to progress the area of clinical trials forward. I've just historically always been in the mindset of collaboration is always what's needed to drive anything forward. I mean that's a very generic statement. But specifically in clinical trials, there's so many different players, and we all know that clinical trials don't always go the route that we want them to or expect them to. And it's really important that we have a very close knit group of folks that kind of leave the egos outside the door and are all at the table with the same vision and mission in mind, which is really to drive forward what we're trying to do with clinical trials, which is essentially getting medicines faster to patients globally. And that takes a lot of coordination and a lot of hoops and a lot of players. And so what I felt that the GIP did for that particular mission is bring everybody to the table and that was something that as a site we wanted to be a part of so really the focus, not just being on the U S focus being globally, and that was something that was really important to us for obvious reasons.

Jimmy Bechtel: 5:03

Oh, that's great. Thanks, Rani. It's always fun to hear why certain organizations join and the alignment that you have and the recognition of that collaboration that really is core to what we do, and I know there's also some interest in the geographies that you all TSTrials specifically is centered in and our recent foray into the Latin American region and South America, things like that. So I know there's alignment there as well, which is also really exciting.

Rani Khetarpal: 5:30

Right. No, absolutely. That, I think we have our even coming from the sponsor size, right? The U. S. and the European sites are always sort of primary in front of mind, but we have to remember that there is a whole world out there that has the capabilities and truly have started. And so obviously the desire to really bring that forward through G. I. P. is front and center for us as well.

Jimmy Bechtel: 5:54

That's excellent. And thank you, Rani. One of the really cool things about TS is that your patient retention rates across your trials averages about 95 percent from what we understand, and your NPS, your net promoter score of over 80 percent is also really, really impressive, right? It kind of goes to speak to this air of patient satisfaction and success that you have with the work that you all do. So can you share maybe some of the strategies and the culture maybe as well that contributes to such a strong level of patient engagement?

Rani Khetarpal: 6:28

Yeah, so I think there's a couple things here. First and foremost, I think if you look at the culture of South America in general there is a different mindset to the population of wanting to contribute to the advancement of global health. And we saw this specifically at TSTrials during covid. And while they're, you know, and we all are in the United States, I was here too. Right? So we all know sort of the tumultuous year that 2020 was and the sentiment towards vaccines and so forth. You don't find that in South America. And so I think just understanding that there is a whole population out there that in the countries that we are in that really want to contribute. And I don't know if you or your listeners know this, but in Argentina, we cannot compensate patients for participation in clinical trials. It's against the law. So everyone that participates in a clinical trial is actually considered a volunteer, so we call them volunteers which blows you away when you think about how much we have to compensate here in the U. S. specifically and even in Europe and in some countries where that's how you actually attract folks, right? Is through compensation. And we don't have that down in Argentina. So I think the first and foremost factor is just the mindset of the population. I think the second thing is the programs that TSTrials has put together specifically for that retention and for people to come back. So when Dr. Romina Libster, who is one of our founders and is our chief strategy and innovation officer, actually created a very robust patient navigation, clinical trial navigation program that's in house. That program basically creates an environment for the volunteer that's going through the trial. Resources 24 hours a day, seven days a week. We have the ability to follow up with these patients in real time. We have the ability to triage issues that might actually lead to an exclusion a dropout for that patient before they even happen. Each patient is assigned a medical director and a clinical coordinator or we call them patient coordinator that allows them to follow these patients in real time from pre trial all the way to post trial. So while there are facets to the trial process where we can't treat a patient for anything, right? We can only provide oversight. We can identify potential issues that would come up and then refer them out to their physician and the network that they're in, which we have access to as well. So those patients are triaged and we can kind of catch problems before they arise. I think also the psychosocial elements and the logistical elements of making sure patients show up to appointments and trials and making sure that they're completing what's needed, they're reporting in as needed. That's all kind of done within that navigation process. So, without going into too much detail, cause I can do a whole, hour, two, three hours on navigation within clinical trials. I think that experience also lends itself to not just a really high patient retention rate, but the ability for these patients to want to participate again, because they're getting that oversight, because they're getting triage, because problems with their health care are being triaged prior to them actually experiencing them. And I think that level of care. They want that again, their experience, their volunteer experience is so high not only are they coming back, they're referring their friends and family to come in and be part of the trial, which is exactly what we want. Right? So, I think there's a couple things there that contribute to that high patient retention rate and that promoter score.

Jimmy Bechtel: 10:14

Yeah, no doubt. It's really interesting. Rani, given the situation, even I wasn't unaware of the fact that you can't reimburse patients in Argentina because we talk kind of the opposite here in the United States, right? We're fighting for the reduction of patient taxation of their compensation so that they're able to retain a larger percentage of that compensation that they get for their time here. So it is so interesting and to address that it seems like you've taken this approach of a really high touch in a situation, right? We talk about all the time in research, how research should be this VIP experience. These people are quite literally volunteering themselves to be part of these clinical trials. So we should give them a higher degree of service. And touch than we might in standard care or a regular clinical setting. So it's great to see that TS has really embraced that mentality and you provide that really high degree of service and touch. And I think it goes to show. It is reflected in that 80 percent NPS and that patient retention rate of over 95 percent. Those patients feel valued. They feel that they're part of the process. They feel that they're cared for every step of the way. And so that's really cool to hear. And I think there's lots that not only our sites could probably glean from some of that perspective but also some of our other sponsor and CRO partners as well. And how they approach the resources that they give to patients and to the sites.

Rani Khetarpal: 11:41

Yeah, I mean, absolutely. And just having again come from the sponsor side. That is the biggest issue, there's 3 facets, right? Is identifying the patients, making sure you have a population that you can draw from, the 2nd would be actually getting those patients into the trial, right? How are you recruiting? And then are they staying, are they able to complete the trial? Right. Trial completion rates are huge. If we don't have trial completion rates, I mean that is one of the biggest factors and not actually having as a sponsor, you want your asset and market as quickly as possible, right? I mean, that's the bottom line. If your patients are dropping out of your trials. For it doesn't matter the reason if they're dropped, if you have a high dropout rate, your assets sitting there, you're not getting that to market. So I think there's a huge domino effect in that patient retention rate piece that I think would be super interesting from a sponsor's point of view to really understand the downstream effect. And with that high patient retention rate, what that can actually do to the time to market for their asset. So, especially if you're in like a phase three situation.

Jimmy Bechtel: 12:44

Absolutely. It's great points. So thank you for making them. Rani, I know that TSTrials also really emphasizes diverse patient demographics, particularly including vulnerable populations as one could draw conclusions to and imagine given the populations that TSTrials works with and the regions there's a high degree of diversity and vulnerable patient populations and in the clinical trial space there. So what approaches have you all found effective in engaging and obviously retaining these groups as well?

Rani Khetarpal: 13:14

Yes, I think it goes back to number one, again, that patient navigation piece where it's not a one size fits all. The service that we provide in that oversight to the patient is tailored specifically to the population that we're serving at the time regardless. Right? So I think that's number 1. The 2nd thing is that the connection that we have with the patient and how we actually approach the patient for a trial. I will give you an example with COVID during we were the single largest site for the COVID trials for the Pfizer vaccine that was approved for emergency use authorization in 2020. Within a 3 week time frame, we were able to recruit over 4, 000 patients into that trial within Buenos Aires, which is where the trial site was. That is pretty much, I've never heard of another trial that's been able to recruit that many patients within that small of a time frame. Part of that success factor, which they've been able to replicate since then is that they went into the barrios. Buenos Aires, they connected with the patient one on one. And when you think about the patient population that they needed the vulnerable patients as well. Right. I mean, you've got high risk patients, you've got the elderly, the over 65, the infants and children eventually, like those folks that we really needed to get in we had to go find them right in a timeframe. And in an era where everyone was on lockdown. So it's not like people can just walk in. You can go out and recruit from physician offices like you really had to figure out how to do it. So they actually went into the barrios and went door to door and connected with the patients at their level, and they saw the patients where they needed to be seen and they committed to these patients of what the experience was going to be, and they followed through. I think especially with the vulnerable patients, and I say vulnerable because we do maternal fetal, we do infant, we do elderly and high risk, right? Specifically, those maternal fetal infants and elderly, they're, they don't trust a lot, right? I mean there's a huge trust factor. I think that ability to connect with them where they are in their own environment, I think, was a really important piece of that success story and continues to be. I think the follow through of we're going to do this for you. I mean, we had transportation set up for these folks. We bussed them into the site, bussed them out right back to their homes. And remember, these are all volunteers. These are not people that are getting paid to do this work. I think there was a legitimate connection to the patient that. What has been replicated since then in the last five years, which has added to the success of the trials that we've been able to do since then across therapeutic areas.

Jimmy Bechtel: 15:59

Rani, what's really interesting about that is you guys have kind of embraced and again, ingrained culturally this concept of meeting the patients where we are. It's something that again, just like some previous answers you've given, we've talked about a lot. And I think what's really exciting. One of the things I'm taking away from this call today about you all joining the GIP program is hopefully multiple opportunities to amplify and showcase some of these exciting core values that TSTrials has to the rest of the SCRS community. Because again, this idea of meeting the patients where they are is something we talk about. And not a lot of organizations have been able to find success really across the board, right? Site sponsors, CRO service provider, you name it. So it's cool to see examples of what is arguably a really challenging situation in some of these really economically challenged areas of the world. And you've been able to get in there and really help these patients out through enablement of clinical trials by again, meeting them where they are. So that's really cool to see and I'm excited for the opportunity to hear more about this and maybe some more details about this work and what you've been able to do and how you did it right in the future. When we have more time. of course.

Rani Khetarpal: 17:12

Absolutely. Absolutely.

Jimmy Bechtel: 17:15

So Rani, I want to begin to conclude us here with our final question. What's next for TSTrials? What's on the horizon for you all? What excites you about the future of the organization?

Rani Khetarpal: 17:26

You know, what's exciting to me is we're just getting started. You know, right now we have organically been getting our trials and they haven't done any sort of, I would say PR sales, commercialization, whatever it is you want to say is we're getting out there now. And I think there's a couple of things is 1 is we really want to promote South America as a place for clinical trials to become a primary thought process for site selection. There has been a traditionally, and of course I'll be the first one to admit. I was in this camp, when I was on the sponsor side as well. Well, you know, South America, yeah, they're more rescue side. They're not really primary. I think one of the things that I've learned over the course of working with TStrials is that there is tremendous potential down in South America. And I think one of the biggest things for us at TSTrials is really getting the word out about South America, about Argentina, about things have changed down there from what reality wasn't even just a few years ago. So really understanding how things have evolved down there and that we can actually step up and become a primary site and primary thought process for site selection. And I think the second thing is really just getting the word out about our capabilities. What we experienced in the COVID trials and since the COVID trials specifically has been nothing short of amazing. And we're excited to bring that forward. We're excited to scale into different therapeutic areas. We're excited to show the trial community what we're capable of. And we're just getting started. So a lot more to come and a lot more to share and a lot more to learn. And we're excited to be part of the community, in being able to accomplish that.

Jimmy Bechtel: 19:06

That's excellent Rani and really excited to have TSTrials in the network as part of SCRS. It's encouraging and I think the rest of the sites not only in the GIP program, but across our membership have some really interesting things and a lot to learn from you all. So thank you for your time today. And really excited again for TSTrials to have joined the GIP program.

Rani Khetarpal: 19:26

Thank you. Appreciate being here and thank you for the opportunity.

Jimmy Bechtel: 19:29

I would also like to add for everyone listening to make sure that they don't forget to explore other site focused resources made available for the community on our website myscrs. org. This includes not only SCRS Talks but other publications made available throughout the year. I'd also like to draw everyone's attention to upcoming site solution summits that can't be missed. And our ambassador program featuring countries, just like ones we talked about today in South America and Latin America, thanks again for listening and tuning in and until next time.