Partnering for Success: Merck's Four-Time Eagle Award Win

Jane Hiatt, Executive Director of Clinical Operations at Merck, shares insights into why sites have recognized Merck as Sponsor of the Year for four consecutive years. Learn how Merck prioritizes site partnerships through active listening, transparent communication, and operational improvements including query simplification, streamlined payments, and technology solutions that address real site needs. Jane discusses specific initiatives that reduce site burden and explores how Merck plans to continue evolving relationships with sites while leveraging emerging technologies like AI and machine learning.

Transcript

Jimmy Bechtel: 0:01

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 have the pleasure of interviewing today. Jane Hiatt, the Executive Director of Clinical Operations with Merck. Because Merck is this year's sponsor, recipient of the Eagle Award a prestigious honor. Really excited to talk to you, Jane, this year about, some of your thoughts around, what you all have been doing that might have lent you to be the sponsor of choice this year amongst the sites. But before we get into that, Jane would love a brief introduction and learn a little bit more about you.

Jane Hiatt: 0:48

Thank you Jimmy. I'm honored to be here as well, so I'm Jane Hiatt and I actually, I head up, for the US our site relationship management team. I also have our site monitoring and management team, so all the CRA's that support all these great work that we do with our sites. I've been with Mark for about 25 years and have been working with SCRS for several years on just how do we continue to help support the relationships and the great partnerships with our sites. I'm just really, excited to be here to share a little bit of the insights from Merck's perspective.

Jimmy Bechtel: 1:19

Excellent. Thanks Jane. Well, let's get into it then. So, as I mentioned, Meck has now received the Eagle Award this year, but also three years prior. This is the fourth year in a row. you guys have surpassed, the proverbial Turkey and our four timers now. So what do you think derives that consistency around trust and recognition from sites around the globe?

Jane Hiatt: 1:42

Well, let me first start by saying I am deeply honored to receive the, CRS Eagle Award for the fourth consecutive year. And, you know, I was able to be the one to receive it personally at the event, and it is, such a recognition of. What we do every day matters and how we partner with our sites and we do focus on what that partnership means. How do we communicate with our sites and how do we engage the sites early and often? And you know it that relationship depends, meaning like it's not a one size fits all because you could have academic sites, community sites, you could be based in the US X us. So how do we go about ensuring that we prioritize being dependable? Transparent and a proactive partner with our sites. And we do that by a lot of active listening and getting that feedback from our sites. And that's through multiple avenues. It could be whether it's direct outreach by our clinical teams, by our operations teams. We conduct site surveys to hear directly from them, from our sites on what's working and where do we have opportunities and challenges. It could be one of our clinical research managers, a combination of both. We have our clinical operation manager, so we align these particular roles with these institutions to really help understand and work closely with them on what are some of their challenges and how can we partner with them differently with, through some of those solutions. And I think about some of those opportunities over the last couple years. Like, you know, we've recently over the last couple rolled out, electronic site file binder. We've continued to look at how do we improve our budget and payment schedules. we partnered closely with SCRS and rolled out some diversity toolkits and how can sites utilize that information. And, you know, as I step back and reflect, it's like one of the things that we think is incredibly important. Is those site engagements, whether it's face-to-face, whether it's, you know, over the phone and having dialogue. But it really helps to foster that long-term relationships. It helps us to sustain trust because they know us, they, and we know them. And it really does ensure that true partnership and collaboration and it anchors our relationship with some shared goals and respect. The other thing that we look to do is, clinical trials, they continue to get more complex and there's more tools and more technology coming at our sites. And so how do we help onboard and train site staff to help them feel empowered, to feel confident and supported in their daily operations and in their role in the shared responsibility for our patients.

Jimmy Bechtel: 4:03

Well, there's a lot to unpack there, Jane, but I think that's the idea, right? it's not one individual path, or not one solution. Because there's so many different areas in which we can have impact for so many different. Types of sites what one site might need or what works for them or what their biggest pain point is, is gonna be different from the site that's next door to them. So taking this multi-pronged approach, really identifying as you, again, so eloquently put so many of those different. high impact areas of change and improvement. You've been able to position yourselves as those that are truly listening to the sites and doing things that the sites really want instead of, Wasting energy on things that, are no value add for the site relationship. So kudos to you all for really listening, as you said, to the voice of the sites through avenues like SCRS and addressing, the areas in which have the most impact for their operations.

Jane Hiatt: 5:01

And Jimmy as you were saying that it made me think about, 'cause I maybe I didn't, stress this enough as well. It's like our CRA's are that primary point of contact for the site and it doesn't mean it's the only one having those engagements, but we do feel that that also helps to foster that trust and relationship because they have sites have a direct line of contact with their CRA's and those CRAs are. Trained and, well versed on their protocols and the therapy areas. So again, it just sets up the team, the site and Merck staff to be well equipped to support those studies.

Jimmy Bechtel: 5:32

Absolutely. Right. the individuals that are maintaining those relationships, that key point of contact, are such an essential part of all the rest of it, right? it's tough to have any of that or any of the successes without the people that are liaising and making sure that work is personified and exemplified at the site level. So Jane the Eagle Award reflects again how sites experience their partners. Partnerships with sponsors. So can you hone in, and you mentioned several different items here, but maybe hone in on some specific ways that Merck ensures that collaboration with site remains strong, transparent, and mutually beneficial. And I think you gave a really great example there around the CRAs, right? Your, your site relationships, but provide maybe some other examples that you might be thinking of.

Jane Hiatt: 6:18

Yes. Lemme talk about a couple of different examples and again, thinking about our sites, like we, they are essential to trial success and we can't do what we do without them. how do we include them early and often in discussions, whether it's around thinking about some designs or maybe thinking about operational efficiencies, and can we partner with them to ensure that. As we start to implement something new, and I'll talk about technology for example, can we get their feedback? So for example, we we're in the process of implementing a new EDC system from ir, and it's a big undertaking, but that EDC system will also then impact the sites. So we've reached out to sites across the globe and just asked like, you know, for their input and be a part of the developing of that, of that solution so that we're not doing it in isolation, but their voice is heard, right? So it's important that they're part of understanding what we're rolling out and then. Taking that feedback and perhaps implementing and changing the way that we roll that out. So that's a really key component of what we do in trying to get feedback. Also talk about, you know, we recently, well I mentioned earlier, we do surveys and one of the common theme in our surveys was, man, your, your, Your query volume is really high. And so hearing that, it's like, okay, what do we do with that information and how can we potentially look at the root causes of that and understand like what's driving that? And so we launched a query simplification project to look at, again, the root cause, what's the most common queries, and how do we potentially redesign some of our forms to help prevent some of these issues. Listening to the sites and implementing changes within our space. I can talk about other efficiencies that we rolled out, that will help sites, whether it's our budget to payments, and I know that attending some of the conferences. I hear that. Or in talking to sites, I hear them talk about the pain around budget to payments We have taken an effort across Merck, around reducing that administrative burden and helping to ensure timing efficiently, site timely and efficiently site payments, which I think is hugely impactful to sites. We also have dedicated site relationship managers, and they may be called something different depending upon what country you live in, but again, it's individuals that are dedicated to supporting the institutions and manage multiple trials to help address Issues or concerns at a systematic level rather than at a trial by trial. So the trial level issues still happen, but some things are systematic across an entire institution. So how do we support that? How do we make sure that we understand that and then we don't reinvent it for every trial, but we have an opportunity to, hear what the pain points are and then manage that across that institution within our teams. So we do feel like. At sites which we consider our partners, like having a seat at the table and getting their feedback really does help shape some of our operational improvements. It helps to ensure that our collaboration continues to remain pretty strong and we're transparent with them. And I think the last, 'cause I said transparent made me think of another area that we're also very proud that we share with our sites. We call it our Site Health Check report. And it's a way that we transparently share with sites like how are they performing on their study, how are they doing compared to other sites on that study? And it's done in an anonymized way, so I don't know who those sites are, but it allows them to see how they're doing with enrollment, how they're doing with their queries, how they're doing with, protocol deviations. so it gives them a really good snapshot. And so, again, just being transparent around what success looks like and how we can work together as we look to drive that, Performance across that trial or potentially across the institution.

Jimmy Bechtel: 9:42

Excellent Jane. Again, a plethora of different ways in which you are providing that strong, transparent collaboration. And I really like the idea of those reports that you had mentioned, the transparency reports, because so many sites ask for those. it makes such a huge difference. And just helping understand where am I sitting, where am I performing on the spectrum of this trial, particularly in contrast to my peers so that I know. Site KPIs are such a huge aspect of, what it means to be the modern clinical research site, so I'm sure that as well as some of those other items you described are really going a long ways to maintain a positive relationship with the site. Jane Mark has emphasized really a need and leaned into a need for reducing unnecessary complexity and focusing on what matters really to the sites and patients. And I think that's really been evidenced in some of the examples of the work, the resources, time and energy that you've put into some of the ways in which you are enhancing your relationship. With sites. So let's shift gears a little bit and talk about, again, when we look at unnecessary complexity, what steps have you taken to simplify clinical trial operations themselves?

Jane Hiatt: 10:54

Yeah, so, you know, it's a great question and I will say it's an evolving, like it's not a one size and you're done, right? You have to keep evolving, and there's two things I wanna talk about. There are great things that SCRS does, one for example, is around the training and how do we reduce the training burden? Merck likes to partner with you on those type of things as well, those different initiatives, because it's hearing directly from the sites. Then partnering across the industry to say how do we help, look for solutions that can make things a little less complex? So that's how we look to partner with, with you and your team. But then when I think about internally with Merck and how do we take all the feedback that we get from our sites and how do we then continue to say like, you know, how do we consistently look at that information that comes in and like, what are the tools and technologies that we're using and what are those different, I wanna call it our a, a suite of offerings that allow some flexibility and efficiency. So I mentioned earlier like, it's not every site's different and they all have different needs, and so we wanna be careful that we don't roll something out that becomes every site must, must, Accept this new technology and accept this new way of working. For example, we have electronic, site file binders. And it was a solution that we provided to sites. But if they already had their own, that's okay. If they didn't move to paper, well that's okay. It doesn't mean we won't continue to try to convince you to move to electronic. But the point Was hearing that sites are looking for almost like a menu of things that they could potentially implement. And so we wanna make sure that we give them those options when we can. You know, we talked about like we've got different, I. Recruitment and retention tools that help support enrollment. We have site augmentation. And again, not every site needs that. So understanding what their needs are. And then here are the, you know, the potential tools in our tool belt that we can provide to the sites. Gosh, I remember being at one of the conferences and I can remember sitting in a session and the sites talking about all the technology that they're expected to learn, and every technology has a different sign on. And so we, you know, hearing that, it's like, how do we reduce that? How can we provide a single sign on to reduce the login for sites? And so that's something that we're rolling out as well. So again, it takes a team within Merck To listen to the feedback and then making sure that we can, mobilize the right functions within our organization to say, okay, how do we now implement some of these changes? And some will involve a technology solution, Which we know sometimes that creates a burden. But then how do you roll that out that potentially meets the needs? Like it, it's not, will meet the need of that particular site, but also allow some flexibility in the use of that technology.

Jimmy Bechtel: 13:30

That's great. Jane, what I really appreciated about your answer is you gave some great specifics on areas of focus from a clinical trial operations improvement perspective, but what I think is really important is that you were able to talk to and demonstrate truly listening to the sites and just doing what they need on a. semi individualized basis. Realizing that, clinical trial execution and operation is not a blanket choice that we should be making. It's. Based on the needs of the sites and maybe categorically what they might need recognizing that the, the, the customization challenges that would exist from an operational's perspective. But again, simply just listening to, and then making and implementing those changes, like some of the examples you gave go such a long way with the sites and it sounds so simple to say and it seems like such an easy thing to iterate and to talk about, I recognize how challenging it can be to make operational shifts or clinical trial execution shifts at an enterprise level. and then, proceed with, implementing those changes at the site and patient level. what a. Complex part of the equation that could be. kudos to Merck for, not only listening to what the sites need, but also then implementing some of those operational changes. So looking ahead, Jane. Can you, as we talk about the future and what's next, which is to me, kind of the exciting part. How does Merck plan to continue evolving its relationships with sites? You know, how are you going to, as an organization or, maybe even as just an individual or a department. How are you going to continue to strive for the eagle and make sure that no one else, comes on your territory and earns that award? what are you gonna do to stay on the cutting edge and make sure that sites continue to value the relationship that they have with Merck?

Jane Hiatt: 15:18

Yeah, it's a great question. And you know, our goal is, is to be that most effective partner for our clinical trial sites. And what does that mean? how do we continue to be reliable? How do we continue to be transparent and focusing on enabling their success, and focusing on enabling 'em to bring patient care and hope to patients, right? So how do you do that? And there's so much that's changing in our environment. And one of our future priorities is how do we leverage ai? And machine learning to enhance, like maybe site identification, patient retention even patient matching. and there's a lot of efficiencies that come with that. But you also have to make sure that we've always got that human oversight that doesn't go away. And we need that site partnership to be at the center of that innovation. So how do we continue to bring them into our conversation as we look at these different tools? I will say, Jimmy, like that site engagement continues to be so incredibly important for us. And in order for us to continue to invest in advancing technologies, we have to continue to think about how do we co-create these solutions with sites and involve them in like the testing and the optimization of some of these new systems and processes to make sure that it's meeting the needs. but ultimately we're trying to meet the needs of the patients. And so how do we do that? we've gotta simplify and make things easy for our sites and we've gotta be as efficient as we can for Merck. I always come back to, and maybe it's because I lead that team that really provides a lot of that site relationship, but that is so incredibly important. And so I think for us it's like as we remain committed to deepening those partnerships, maintaining that open communications, whether it's through surveys, it's through outreach, it's face-to-face meetings, and just making sure that as we are implementing changes, that we are being transparent and communicating that to our sites. And sometimes that could be like newsletters that go out, but it's also then the boots on the ground that are taking the time to talk through this new change, And, you know, I continue to think about as we partner with SCRS on the different initiatives that you are continuing to roll out, whether it's, like I said, reducing that training burden. If it's reaching community sites and oncology, we wanna be a part of those discussions because again, it reaches just such a diverse stakeholder network that it's important for us to help be at the table and help drive those solutions. And we ultimately think that helps to also then continue to evolve our relationship with our sites.

Jimmy Bechtel: 17:34

Jane, I think that's a really great place to end our conversation and, and again, what I really, really value, and I know the sites do as well with the relationship that not only we have with, with you all, but also that the sites have is that radical transparency. Everything is done in a transparent way. Everything continues to be. Executed underneath that very intentional purpose. And it's analyzed, it's understood as to whether or not said decision is a good one for the sites and for the patients. Because too often we see the reason the SCRS entirely was founded was because so much of the opposite was happening in the industry. Decisions were being made without the sites. In tow. So it's great. Yeah. To see that tie be made that, an organization that's truly dedicated to that mentality and, and that that purpose be the recipient of the Eagle Award. and it, you know, I, I would encourage others that are listening, other sponsors and CROs in the room that are listening to rise to the occasion, you know, Jane gave not to give the secret sauce away, right, Jane, but that's, if we can do that, we can make a huge advancement in the work that we do in, in clinical trials. And for the sites that are listening. Hold your sponsor and CRO partners and hold Merck you know, in particular to that standard and make sure that that work continues to happen and that we're able to personify and, and celebrate when that is done through a ways like the Eagle. So thank you Jane. and thank you for being here with us, and thank you for sharing some of the great things that you're doing. And congratulations to Merck again for this year's Recipient C of the Eagle Award.

Jane Hiatt: 19:01

Thank you Jimmy, and thank you for an opportunity to just, like you said, share our secret sauce. And you know, you're absolutely right. The more that we can support our sites, the more we bring to our patients, and that's what it's all about. So we're here to help do that. And I tell my team all the time, listen, the most important thing that you can do is listen. And with that listening comes then action. So again, I appreciate, that you've given me an opportunity today to speak to you.

Jimmy Bechtel: 19:23

Absolutely. It was my pleasure and again, congratulations to you and, the Merck team and I hope that everyone listening is Sure to, check out other site focused resources made available on our website, my scrs.org, where you can learn about. The Eagle Award and some of our other programs, as well as our site solutions summits taking place throughout the year as opportunities to engage with Merck and many of our other partners. But for now, thanks for listening, tuning in, and until next time.