Building a Sponsor of Choice: How Keenova is Redefining Site Partnership

What does it actually mean to be a sponsor of choice? In this episode, Jimmy Bechtel sits down with Carrie Lewis and Suzy Montanye from Keenova to find out. The two share how the newly formed company, born from the merger of Mallinckrodt and Endo, is building a site partnership model grounded in accountability, transparency, and real feedback. From their site operational advisory board to a dedicated site relationship manager role, Keenova is making the case that mid-sized sponsors can operate like industry leaders. 

Transcript

Jimmy Bechtel 0:00

Hello and welcome to SCRS talks provided by the Society for Clinical Research Sites. With us today are two representatives from Keenova, a mid-sized purpose-driven therapeutics company focused on helping patients with rare or underserved conditions live healthier, happier lives. Let's welcome Carrie Lewis, the executive director of. Clinical program optimization. And Suzy Montney from, Keenova as well in the site relationships as one of their managers. Together they will share how clinical research sponsors and sites can shape partnerships and how Keenova is working to make specialty research more connected, responsive, and site friendly. I'd love Carrie and Susie to hear a little bit more from you. Carrie, why don't you start with a brief introduction.

Carrie Lewis 0:47

Hey, Jimmy. I'm so excited to be here today. So, yeah, I've been in the industry for probably over 20 years. That's includes across academia, global CROs such as PRA and Icon, multiple sponsor organizations such as Shire, Teva, Lupin, et cetera. And I've really worked across many different therapeutic areas, respiratory, CNS, oncology, orthopedics, aesthetics. and I've really just work, to drive innovation, reduce burden. And really what I love to do is foster strong partnerships with my sites and my vendors. and currently at Keenova, I oversee, multiple operational teams such as clinical operations, data management, training and oversight, ETMF and business operations. So I'll turn it over to you, Suzy. Okay.

Suzy Montanye 1:34

Thank you Carrie. I have been with Keenova in the site relationship manager role for about four years, but prior to that I worked as a director at a private research, office for almost 20 years. So in that time we did probably over 150 clinical trials and 50 plus different indications. so it is very exciting for me now to be on this side working as a site relationship manager so that I can work directly with sites to help them as I wish someone had been around to help our site when I was working as a site.

Jimmy Bechtel 2:08

I'm really excited to talk, about this topic today and then sort of introduce Keenova, to the SCRS community, as, as not only one of our newer gis, which is very exciting, but also, as a partner to the work that the sites are doing, So, Carrie, maybe we'll start with you. How would you introduce Keenova to sites that might not know who you are yet?

Carrie Lewis 2:28

Yeah, that is, it's really good question. And I think many listeners, may not know Keenova yet, or a little bit confused when they hear the name. But in 2005, so not just last year, Mallinckrodt and Endo came together to form Keenova, and we really do have a shared goal of building something stronger than either company was able to do on their own. so right now we're focused on taking the best of both organizations and pushing for even greater excellence. a big part of that is carrying forward the strong reputation for site partnership that has been built over many years. we truly do have a commitment that our, is our foundation of how Keenova's operation team shows up for clinical sites.

Jimmy Bechtel 3:10

Wow. It's sounds like, a lot of change that's happened recently to, two companies coming together to form a new one with a new mission and a new direction. Never an easy process. So, Carrie, maybe continuing with you then on that same theme, can you talk about what that merger means for the people within these two organizations coming together and, and the teams that you work with?

Carrie Lewis 3:30

Absolutely. And mergers happen all the time and they're, not always easy, but it's a lot of fun to have some change. but one of the biggest advantages of this merger is that we now have access to new indications that really broaden our reach. so it opens doors for us clinically and strategically, and it positions us to support a wider range of providers and patients than before. So we're truly really excited about it.

Jimmy Bechtel 3:55

I can imagine and, and Suzy maybe share as well, how are your existing relationships or some of the legacy relationships from the two organizations with the sites evolving or, or being enhanced rather under this new structure?

Suzy Montanye 4:11

Well, the one great thing is that we are in a super strong place with our sites as is. We've always had great relationships with orthopedics and podiatry, and those partnerships continue to be a real anchor for us. They know us, they trust us, we collaborate well. the merger really has only strengthened that foundation.

Jimmy Bechtel 4:28

Are there any then specialties that you're hoping to engage with sites, going forward? Suzy?

Suzy Montanye 4:34

Yes. Rheumatology is gonna be a big one for us in the near future with our expanded indications. It makes perfect sense for us to build deeper connections there. It's an area that we see a real opportunity and it's already on our radar. We've already started that outreach.

Jimmy Bechtel 4:48

Excellent. That's exciting. So for everyone listening, if you're a rheumatology site, you know who you might consider reaching out to or connecting with at one of our summits or some of the other events in there. So, Carrie, back to you. Overall, how would you, hearing some of what we've heard then, how would you sort of summarize the direction that you're heading, as an organization?

Carrie Lewis 5:08

Yeah, so we are both growing both in our clinical trial approach and in those relationships that we're maintaining and growing with sites. we do believe this merger really gives us more to offer. Our existing partnerships remain strong, like Susie had mentioned. And we truly are excited to bring new specialties like rheumatology into the fold.

Jimmy Bechtel 5:29

So then building on that, Carrie, can you walk us through what Keenova's operating approach looks like in practice, and whether you're working through maybe these traditional outsourcing models or, or maybe engaging directly with sites and, and what form that might take as, as we move forward here.

Carrie Lewis 5:47

So, Keenova does operate mainly in what we call a functional service provider model. And we believe that allows us to stay closely connected to our site needs and maintain that direct interaction with our partners, which we truly love. We do sometimes fully outsource. And when we can do that, we do uphold our commitment to our clinical sites and we still carry forward those same priorities and expectations that drive our work. But I think what sets us apart at Keenova is we truly like to be that direct contact with our sites, build those great relationships, and truly talk to them often, and we enjoy that.

Jimmy Bechtel 6:23

And we know how important that is for the industry. So it's great to hear that that's a focus for your organization. Personally, I think that will, as you had mentioned, be one of the, differentiating factors that will set you apart from others who might be in the FSP model or, or any other for the like. So let's take that a little bit deeper. Carrie, can you talk about what guides that approach and what values shape the way your, maybe the way and the why your teams show up every day for its sites?

Carrie Lewis 6:50

I think with that it does go back to our corporate values. so our values here at Keenova really guide how we show up every day. not just internally, but how we work with our sites. And I love our values because I think they're easy to live by. so our four values are own every outcome. so we're gonna be accountable every day. We're gonna be curious, which is my favorite value. And I love when people ask us the why questions. or we challenge status quo. We're gonna step up and then we're gonna grow as one. And that includes with our, you know, growing our partnerships.

Jimmy Bechtel 7:23

That's excellent to hear. So when sites think about partnering with a sponsor, we know that they want to understand. What that relationship will feel like. It goes beyond just, you know, what is the protocol and, and what are we asking things to do. It transcends that into, again, how that relationship is really going to feel, both in the short term with that particular trial instance, but in the long term as well, sites aren't interested in one and done opportunities. So, Carrie, from pulling on that thread and kind of, bringing those, those values into that, from your perspective, why would a research site want to partner then with Keenova?

Carrie Lewis 7:57

Yeah. we really do want our sites to feel they can rely on us, and like you said, we have worked with many of our sites for, many, many studies. but that's why we focus on being what we call a sponsor of choice. And I promise you, it's not just a title we assign ourselves. it's something we, we earned through consistent, consistent actions and follow through. And the team really every day strives to keep being a better and better sponsor of choice for our sites and make that a priority in our daily work.

Jimmy Bechtel 8:27

And the cool thing is, is that it sounds like it's aligned really nicely with your, your four values and may, maybe not all four of them directly, but definitely a couple of them around stepping up and growing as one and owning those outcomes. And you could even make the argument for be curious and, and how that aligns with that. So I, I wanna carry, I want to tug on that, be the sponsor of choice. 'cause that's a word that gets thrown around a lot and everyone seems to say that. But what does being a sponsor of choice mean to you?

Carrie Lewis 8:53

That is true, and we wanna make sure we live by it and, our site should hold us accountable for it. But what it means, I think, to myself at least, is it means listening with intent, and then truly acting on what we hear. so when sites raise concerns or ideas, I, I truly know in my heart, we look at how to turn that feedback into real operational changes and maybe we can't do it right that moment. but we'll definitely make sure it's on our radar and, really work for that, that change.

Jimmy Bechtel 9:19

And that's huge. That really does go a long way with the sites when we start to put that complete feedback loop into action and build it into the, relationships, and, and how they're managed. So I want both of your perspectives on this next question here, but can you share. An example of how listening has led to real improvements, right? You know, kinda money where your mouth is here, right? Carrie and Suzy is, well, where has this really translated into, into some, some positive outcomes? Carrie, we'll start with you and then Susie, please chime in.

Carrie Lewis 9:48

well, one of my favorite things and what I just enjoy the most is our site operational advisory board. so Suzy and I created that. So sites have a direct and honest way to tell us what's working and what isn't. and that input has led to practical changes. So that might have been from re. Defining escalation pathways, to improving contact lists, which seem simple, but you know, little things can go a long way for making it easy to know who to contact for which thing, and having backup contacts, and just communication clarity

Suzy Montanye 10:18

Yeah, I was just gonna say, the board is one of my favorite initiatives as well, and really what we do is we, each year we'll bring together about 10 sites to give feedback on. A whole variety of things. We do everything from study startup to how our feasibility forms are, you know, could we change them in any way? How do the sites like our contract and budget process? is there any feedback that they have on training or, you know, giving us feedback on specific vendor interactions that they've had. And really what these conversations are very open. they can be challenging sometimes, but they've really helped us to understand what the site's needs are. And it's helped us to improve our internal processes. So having an open conversation where everybody feels, I believe, comfortable and free to, to speak honestly, has really helped us to make changes. And, you know, this includes even learning some specifics about our budget practice. And even though we had good intentions, we learned that we were actually making the sites review more difficult. So as a direct result of that insight, we were able to make meaningful changes that made things Easier for our sites.

Jimmy Bechtel 11:22

Well, and not to open the, the can of worms here too much, but you, you said it, Suzy budget woes and budget challenges Mm-hmm and we know there, they continue and, and are consistent real issues across many industries and, and payments can be a major concern for the site. So can you maybe Carrie, to piggyback on that and talk a little bit about how Keenova approaches, payments and, and the like.

Carrie Lewis 11:47

Yeah. honestly, we wanna take a very practical approach to site payments. We will not do holdbacks. We wanna pay for screen fails, every screen fail. That's still work done. we wanna pay sites monthly, not quarterly. and we really want it to be predictable. Timely, of course. because we believe that's essential to Healthy Site partnership. one thing I'm kind of learning might set us, set us apart is we do remain open to renegotiate our, our, budgets and clinical trial agreements. As new information emerges or maybe new circumstances evolve during a study, we will have those discussions and make sure we're fair.

Jimmy Bechtel 12:23

Well, that's music to my ears, and I'm sure to several of you said all the right things, Carrie, to, to several of the sites on the call as well because, you know, like you had mentioned, it's one thing to have, you know, no hold backs or consistent monthly payments. But then the ability to, reopen and go re-approach budget negotiations is a huge win for the site side. So kudos to you all for bringing that in. shifting gears a little bit, Susie. I imagine you also spend a lot of time at meetings and conferences, talking with different people that work in similar environments and the like. So how does that opportunity, or those conversations help shape your approach to, working in the industry?

Suzy Montanye 13:03

Yeah. Conferences are actually very helpful because it really gives us exposure to a broad range of site perspectives, and it gives time to really just sit down and talk to sites. Again, in person about concerns or things that are changing, and we will use those conversations really to just understand not only individual sites issues, but industry-wide challenges. And then we can use that information to work internally to address them. We also collaborate directly with our sites that we're using for our trials to get real time feedback as we're going along to ensure that our changes genuinely improve workflows, start up and visit, execution. So not just. You know, what's the feedback and okay, we appreciate it, but we really use it to make change.

Jimmy Bechtel 13:45

That's a great set of points. Suzy and Carrie, it sounds like that part of that then is the partnership is core to your, philosophy and the organization.

Carrie Lewis 13:55

it really is, and I, I really do think our current sites would agree, agree with us. I hope so. and we are very clear that our success depends on the way we do partner with the, our sites. We know that and we do approach our work as a shared responsibility. And I can tell you our teams actually take the personal ownership in making those partnerships work because it is so important to us.

Jimmy Bechtel 14:18

I want to key in on that a little bit and some of what you've talked about previously. 'cause you did mention a lot we've used the word partnership and sponsor of choice and how important partnership is to be the sponsor of choice. So Suzy, what would you say is one of Keenova's biggest assets in making that a reality?

Suzy Montanye 14:38

Well, I would say that one of our biggest strengths is our site relationship manager role, which is my job. Since we are a mid-size company, we feel very fortunate to have the internal commitment to invest in this position because not all companies our size are willing to invest a full-time position into just maintaining relationships and getting feedback from sites.

Jimmy Bechtel 14:57

Well, and you're a hundred percent right, Suzy. It's not, a universal model. It is an investment, from the perspective of the partner organization, whether that be a sponsor or a CRO. So it sounds like that role, has been a major part of your evolution. So I'd like to, to tease that out a little bit and talk about that. So, can you tell us how the role came to be and, and some boots on the ground insights about your job and, and some of the things that you're seeing.

Suzy Montanye 15:21

Sure. So the role actually grew out of initiative that we launched that was called the Year of the Site. It was supposed to last 12 months, but it never really ended because we saw the importance of. The commitment that we have to our sites on a daily basis. So the initiative pushed us to really look more closely at how we support sites and how we bring their perspective into our process. So one of the things, as an example that we do to always make sure we're bringing the site's perspective in is that before we finalize a protocol, we do a full walkthrough where we do a role play and the site relationship manager, which is me, I act as the coordinator. So I actually go from. You know, inform consent all the way through to the final visit and walk through every element of the protocol, every procedure. And then we have another team member that plays the participant. So this really helps us to catch issues early on and to make sure as best we can, that the protocol aligns with real site workflows. The role also reviews all site facing documents. So I support data management on queries CRF guidelines. I also visit sites in person, or sometimes it's a, it's a virtual, but that helps to build a relationship. And all of this came from recognizing that sites are essential partners that we need to design our work with them, not just for them.

Jimmy Bechtel 16:39

I love that this is such a hands-on approach, right? It's very, very tactile and interactive and ingrained in what you do and the relationship part of how you execute, your, your processes with clinical trials. So what else can you share, Suzy, that this role brings to that excite experience?

Suzy Montanye 16:58

Yeah, it is a very hands-on approach, and I think, honestly, listening is the biggest part of it. When sites tell us something isn't working, we evaluate it and then we make tangible changes. We have revamped our training expectations, we've streamlined our communications, improved our query process, and shifted to picking up the phone instead of just sending correspondence or unnecessary queries. We also send an annual survey. to get feedback on our, our ClinOps process, and then we personally call back anybody that has a, a concern, we will call them back personally to discuss whatever that concern was. and the other thing I think that's important to note is just that every site is different. So we train our clinical operations team to actually get to know each site. It's not a one size fits all. We try to customize wherever we can, whether it's communication style, document preferences, or how they like their feasibility form, but really drive home that you have to treat in each site individually. And in my role, I'm a dedicated point of contact who understands these site's challenges. Because I was a site, I, I know exactly, I did everything from regulatory budgets all the way through running protocols, running the studies, and, you know, seeing the patients. So I do understand what their challenges are, and I can help to resolve their issues quickly. This ensures that their site perspective is brought into all of our internal discussions, so they can always call me directly.

Jimmy Bechtel 18:23

That's excellent, Suzy, and that availability is again, one of the things that I, I view as really setting your organization apart and in addition to that role. So thank you for sharing a little bit about that. But Carrie, back to you here. Suzy mentioned that every site is different. We know this and that really shapes how everybody works with them and how it sounds like it shapes how you work with them as well. But building on that, can you talk a bit about. That new or, or naive or inexperienced sites and why they're such an important part of this picture and what that means to you all.

Carrie Lewis 18:55

Yeah. it is very tempting to rely on familiar sites. So we really challenge ourselves to not fall into that kind of status quo mindset. So we want to bring in new sites. We think it strengthens the research infrastructure. There is high turnover among investigators that can disrupt trials. But if we're offering that tailored support, we try to help our new sites contribute, to the research and we really wanna give people a chance and kind of give them the tools they need to help them be successful.

Jimmy Bechtel 19:25

Carrie, you're exactly right. Investigator turnover we know is really a hot topic, it's something that we've discussed. It affects every sponsor and every site, and most notably, the people that are actually doing this work and, and trying to execute this and, and unfortunately then the patients as well, which leads me to ask my next question around managing talent and resources in, its how it's become so complex and complicated in the industry. So how are you approaching this, Carrie, and thinking about this at Keenova?

Carrie Lewis 19:53

Yeah, it really is a focus for myself and the team. the industry is evolving quickly and I think the way we think about talent has to evolve with it. So we're looking closely at how we bring people into the organization, how we support them, how we create space for new perspectives. and that includes being open to different backgrounds, different career paths, and different ways of contributing to clinical research. so we truly do try to bring in, different walks of life and give people that first opportunity.

Jimmy Bechtel 20:22

That's great Carrie and Suzy. And you know, as we start to, the last couple of questions here, we start to close, but the golden question for the sites on the line who are listening and, you've said everything right and they're really jazzed to work with you. For, for those that are listening, what is the best way for them to reach out and get in contact with your organization?

Suzy Montanye 20:41

sites can contact us directly at clinicaltrials@endo.com. we do monitor that regularly.

Jimmy Bechtel 20:49

And as a GIP, A Global Impact partner with SCRS, what do you hope to accomplish together for sites and patients? Maybe start with you, Carrie.

Carrie Lewis 20:56

we really wanna continue learning from our sites. we wanna keep strengthening that partnership model and we truly wanna help create an environment where our trials are more efficient. That's a huge goal for us and something we strive for every day. we wanna continue to be supportive to our sites and ultimately always make sure we're very patient focused.

Jimmy Bechtel 21:15

I couldn't agree more. And it's so great to hear that. And before we wrap up, I of course want to thank both of you for sharing your perspective and giving our listeners a clearer picture of how your organization, this new organization here, Keenova Approaches site partnership. And it's been great hearing on how you're building those strengths and investing in the site experience.

Carrie Lewis 21:35

So thank you for having us, Jimmy. It was really fun and we're so glad to be able to get, our name out there and so people know who Keenova is. and we appreciate the chance to talk about the work we're doing, the partnerships we wanna keep building across the industry. And again, we may be a mid-sized organization, but we truly push ourselves every single day to operate like industry leaders. and the core of that ambition is a simple belief. Absolutely possible to be a good partner while still driving that high performance.

Suzy Montanye 22:04

Yes, and I thank you too. I do. Echo carrie's final words and I wanna add that we truly value every opportunity to listen, learn, and strengthen how we support sites. We're excited for what is ahead and we're grateful to be part of this conversation.

Jimmy Bechtel 22:19

thank you again to the both of you and for being here today. And thank you, of course, to everyone who's listening. We look forward to continuing this discussions and highlighting partners who are working to make research stronger for sites and patients. So thanks for tuning in for listening, and until next time.