SCRS Talks

Better Trials Through Stronger Site Partnerships

SCRS

Discover how stronger CRO–site partnerships are reshaping clinical trials with Scott Palmese, Executive Director of Site-Focused Solutions at Worldwide Clinical Trials. He shares why listening to sites, reducing burdens, and building trust are game-changers for successful clinical research. Tune in to learn how rethinking these relationships through transparency and communication empowers sites and fuels faster, more successful trials. 

Jimmy Bechtel:

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 Chief Site Success Officer with SCRS, and I'm joined today by Scott Palmese, the Executive Director of Site Focused Solutions with Worldwide Clinical Trials. Scott is joining us today as one of the newest members of the SCRS Global Impact Partnership Program. We're excited to have Worldwide Clinical Trials as a GIP, and we're gonna learn a little bit more about them and their motivations for joining that program today. But before we do that, Scott, I'd like to turn it over to you and have you start us off with a little bit of background on yourself and maybe some on Worldwide Clinical Trials as well.

Scott Palmese:

Thanks Jimmy. Really excited to be here. My name is Scott Palmese, and as you said, I head up our site focused solutions at Worldwide Clinical Trials. And what that basically means is that anything related to relationships or partnerships with sites outside of project work kind of falls with me and my team. I'm super excited about this role because my background is mostly site focused. I started a research site in central Florida, mostly focused in CNS indications, and I did a variety of different roles there for a number of years. I coordinated trials, I did some patient recruitment, some business development, some finance. Really got to understand all of the different roles that make a site run as it is supposed to run. From there I worked with a site network for about seven years helping sites with a variety of different operational processes, Business development, setting up staffing models and looking at different ways to run clinical trial budget negotiation and everything sort of in between. After I did that, I had been in the site world for about 10 years and I decided to move to the CRO space. And while I've been at the CRO side of the industry, I have been focused on sites as well. I worked with a larger CRO before my time at Worldwide and oversaw one of the large global site networks for a few years. And then I've been at Worldwide now for about two and a half years, about a year or so in this site focused role. We're really excited to join the Global Impact Partner Program and continue to enhance our relationships with sites.

Jimmy Bechtel:

Excellent. Thanks, Scott. That's really exciting and again, thanks for joining and welcome to the GIP program. I'd like to start by understanding a little bit more about what motivated or inspired Worldwide to join this partnership and be part of the GIP program.

Scott Palmese:

Yeah, well, many people listening on the phone probably know me. I've been going to the SCRS conferences for probably the better part of 10 years now. It's always been a really great community of sites that want to work together to make the industry better. When I came to Worldwide, I felt that we could do more when it came to how we collaborate with sites and how we develop our operational processes to fit in with sites and their operational processes. It's a good time for us to, now that we're starting to build our processes and our team and starting to build more relationships, it's time for us to become kind of part of the formal community. We want to share best practices on our side here. Best practices from sites and make sure that as we are continuing to grow at Worldwide, that we're considering site needs and how sites are evolving in the way that we grow. Because at the end of the day, we can't execute our research successfully unless we're partnered with sites.

Jimmy Bechtel:

I couldn't agree more, Scott. You share a common sentiment motivation that a lot of other organizations do, and that's a very strong foundation for setting yourself up for success in the GIP program. Really excited to have you guys. But for those who may not be familiar, can you share. I guess expand on your introduction and a little bit more about Worldwide Clinical Trials and what makes you guys different? What makes your approach to clinical trials unique?

Scott Palmese:

Yeah, absolutely. Having been at another CRO and having worked with a lot of the major CROs over my 15 plus year career, Worldwide Clinical Trials is definitely different in how we look at clinical research. One of the first things that stood out to me. When I started with Worldwide was just the intentionality of how and what we add value to. Worldwide was started by four physicians and even though that was over 30 years ago, it is still evident today. We are very science focused and we only take studies that we feel we can add value to. Worldwide is very therapeutically focused in the sense that, we know what we're good at. CNS, oncology, cardiovascular, metabolic, immune mediated diseases. We know what we have the expertise to add value to, and we know what we don't have the expertise to add value to, and we wanna make sure that when we do take on a project that it's something that we can do well with. That we have the site relationships to succeed, that we have the operational expertise to succeed, and that we have the medical expertise to succeed. We're constantly making sure that we have the proper relationships in order to really understand, site and patient burden when we look at a study. We really want to make sure that anything that we're doing is something that we feel we'll add something whether it's for patients or for science. One of the first things, going back to what I said that I noticed was, I feel like we take on fewer projects than we see because we want to make sure that we do things really well and that is a difference from other companies I've worked with and is something that excites me about the company.

Jimmy Bechtel:

Yeah, I can imagine, Scott. That relationship aspect, the collaboration and rallying around those singular points is unique and really important aspect of a business, particularly yours that can make or break a lot of different companies. Having those opportunities to do that and building that culture is not easy, I think is really what I'm trying to get at. That's not something that a lot of organizations may talk to different elements of that. I know that would be something I would rally around as a potential partner of yours. Thanks for sharing that. Can you talk a little bit about innovations or different maybe methodologies and approaches that you all are implementing that streamline your clinical trials or really enhance site performance. Things that you're doing that maybe set you guys apart or maybe it's not novel. Maybe it's just something that you guys are really focused on that does seem to make a difference.

Scott Palmese:

Yeah, absolutely Jimmy. There's a number of different things that we're doing. Of course we're a full service CRO, and so, on the surface a lot of what we do is going to operationally look similar to what other CROs are doing, kind of across the industry. Specifically with respect to our site and patient approach, there's a number of different things that we have been doing over the last year and will continue to do over the years to come. The first thing we're doing is, we've really enhanced a site alliance program, and we've enhanced it in a way to make sure that it's very data-driven. What I mean by that is that we're being, very intentional about the relationships that we're forming not just in the United States, but across the world. We, at Worldwide are looking to do more and more global, phase three large studies involving every region that's doing clinical research. And we wanna make sure that we have site partners in those regions that can be, go-to organizations that we can communicate with effectively that get back to us quickly when we want to strategize about the best operational process to conduct a study that we can talk to physicians about patient burden and why a study may or may not be a good fit for their patients. What the disease journey is for patients, given the indication that we're looking at. All those types of conversations we want to have with people all over the world because those experiences could be different in different places. We're looking at data as a CRO where we can see which sites are starting up faster, enrolling better than other sites in their regions, and those are the sites that we're approaching to see if there's room for more of a close partnership or an alliance relationship. We're not building in a quote unquote alliance program that will encompass every site in the industry. Of course, especially in the United States, there are an endless number of sites and networks and all different groups that may have different expertise different patient access. But we really want to work with the best because we want to maximize the relationship with each of the partners that we have. Another thing that we're doing that I'm really excited about is we have in the last six months made a strong internal effort to align not only our site alliance and site relationships group, as its own thing. But we've made an intention to align that with our patient solutions group and also our internal feasibility group because we recognize that our site relationships really can't sit on an island by themselves. We need to see, okay, if we include our key sites, will that improve our feasibility approach to a study? And if we improve the feasibility approach to a study, will that allow us to bring in more work to Worldwide, which will in turn allow us to place more work with our sites, which will then enhance the relationships that we have with the sites in kind of an alliance nature. In a similar way, are there patient recruitment tactics that our patient recruitment team can partner with our alliance sites on in order to develop, whether it's some sort of a central strategy or even a local strategy. We've got a number of alliance partners that do local community events. How can we use our resources to help propel that site forward to not only improve enrollment in our trials, but also to improve that site's profile in their community. Going back to kind of my first point, I think that what we're doing that's unique is being very intentional about where we want to focus our time and where we want to really partner versus essentially saying, everybody, kind of morph everything for everyone. We want to make sure that we can get the most out of all the relationships that we have.

Jimmy Bechtel:

Thanks, Scott. Like I said before, it's not necessarily groundbreaking or novel, but it's so important, it's so foundational and essential to what we're doing here. The program itself, like you've alluded to, having this core group or these partners in your sites is something that a lot of different sponsors and CROs do. What I really liked about your explanation is that it's not just a title. It goes beyond that. It really truly does boil down into something that actually sparks action and makes change and is something that you all can act upon and really work together to advance the speed in which you all are executing clinical trials, and of course the effectiveness and the safety in which you're doing that as well. I also liked that you're partnering those groups so closely together. Sites and patients and the patient focus because we see so often that they're siloed and they're different groups and they don't talk to each other and they have different unilateral focuses. But what we truly know and I think your background at the site for so many years, Scott probably is the impetus for the success of these kinds of relationships and these kinds of programs is that the sites and the patients are really intertwined and interrelated. Really cool to hear some of that approach and I'm sure it will be successful for you all going forward. As we begin to close, Scott and wrap things up, if there's one message that you want sites to hear from Worldwide today, what would that be? What would your, big message for the site community be?

Scott Palmese:

Yeah. I think our big message, Jimmy, is that we are very excited to partner. We really want to be a collaborative partner. Too often I think that C.R.Os in particular are seen as an obstacle to success in clinical research. Whether that's in the contracting and budgeting realm or the monitoring space or you name it. And I think that at Worldwide we have a unique opportunity to really build something new. When I was approached to build this group at Worldwide, one of the first things I said to our senior leadership was i'm happy to do it. That's a really exciting thing to do. But I wanna make sure that anybody that we hire into the team, or anybody that we have on leadership on the team has to have site experience and a site background. I recognize from being at other organizations that it's really hard for people who don't truly understand the site experience to be able to use a phrase that Macaulay used to be able to speak site. To be able to speak that language, to be able to understand what truly goes on at the site level and where some of the challenges are and how ultimately we can add value to that site to help address some of those challenges. We've done that as we've grown our team, people coming in all have site experience, whether that's in leadership or in patient recruitment, you name it. They understand how things work at sites. The last thing I'll say is if anybody wants to reach out and kind of share ideas, share challenges that they're going through, that, you think that a CRO could address that maybe other CROs you're partnering with are not addressing at this time. Would love to hear from you, we are still in the build phase and there is a lot that we can still do. We're excited to try different things, whether that's different partnership structures or certain efficiencies that we want to prioritize and feasibility or contracting. There's probably five things I'm not thinking of right now. Would love to have those conversations as we continue to grow our team and continue our mission of partnering with sites to make it easier for patients to join clinical trials.

Jimmy Bechtel:

Well, Scott, I think that's a really excellent place for us to end our conversation today. Thank you so much for not only being here today with me and talking a little bit more about your organization, but on behalf of the sites, thank you for joining the GIP program and committing to advancing some of those relationships and doing some of the things that I know you mentioned on the call today that will come to life through this program. So thank you again and thank you to Worldwide.

Scott Palmese:

Yeah, thank you. Appreciate the time.

Jimmy Bechtel:

And for those listening, I wanna make sure that you bring your attention to other site focused resources made available through our website, my scrs.org. Like other publications, other SCRS Talks episodes, and our site solutions summits, where you'd have opportunities to engage with companies like Worldwide Clinical Trials, and Scott and his team, and many, many others across the globe. For now, thank you for listening, tuning in, and until next time.

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