De-Risking Clinical Trials: What High-Performing Teams Get Right

Many clinical trials fail quietly.
Not due to flawed science, but because of burnout, leadership gaps, and misaligned execution.

In 𝗘𝗽𝗶𝘀𝗼𝗱𝗲 𝟮 of 𝗕𝗲𝘆𝗼𝗻𝗱 𝘁𝗵𝗲 𝗣𝗿𝗼𝘁𝗼𝗰𝗼𝗹, we’re thrilled to be joined by Suzanne Vyvoda, Founder and CEO of Concordia BioStrategies and a seasoned Clinical Operations Strategist.

With a track record of leading trials across 40+ countries and 500+ sites, Suzanne shares what it really takes to manage high-stakes studies and guide clinical teams through complexity.

In this episode, we unpack the people-driven strategies that accelerate timelines, reduce turnover, and rebuild trust across clinical teams:

👉 Why even well-designed protocols stall due to cultural and coordination breakdowns
👉 How early vendor decisions and internal misalignment quietly derail execution
👉 The true cost of underdeveloped leadership and how to close the gap
👉 Practical tools to reduce firefighting, boost retention, and strengthen morale
👉 How clinical operations leaders can build trial ecosystems that scale without chaos

Whether you're overseeing one study or a global portfolio, this conversation reveals what’s often overlooked, and what’s essential for sustainable clinical trial execution.

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This Show is brought to you by The Research Associate Group, Inc.

Welcome to Beyond the Protocol—where authentic conversations about clinical research happen.

Hosted by Melody Keel, bringing together diverse professionals from across the industry to share insights and experiences about what it really takes to deliver successful clinical trials.

This isn't about perfect processes—it's about real people sharing real solutions.

Let's go beyond the protocol.

That's all for today's episode of Beyond the Protocol—where we explore what it truly takes to deliver successful clinical trials. 

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Have experiences or insights to share? Reach out and be part of the conversation.

Join us next week as we continue to discover what lies beyond the protocol.

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Chapters

• 0:00 Introduction
• 1:32 Suzanne’s 360° Background
• 4:09 Chaos in Clinical Trials
• 6:53 Preventing Chaos Before It Starts
• 11:09 The Training Gap
• 14:02 SOPs vs. Real Operations
• 19:12 Culture and Partnerships
• 23:45 The Executive Role
• 31:24 High-Performing Teams
• 34:34 Final Takeaways

Transcript

Melody Keel: All right. Welcome back to Beyond the Protocol. I'm so excited for my guest today and this topic. I think it's going to be a really great show and discussion. So today we are de-risking clinical trials and discussing what high performing teams get right, and my guest, Suzanne Vata, is with me today. I'm not even gonna attempt to introduce you.

I'm gonna let you take it away and introduce yourself because I think having you on the show and being able to have a discussion from your viewpoint, um, and the role that you have in operations and clinical trials is, um, just really going to be insightful for the guests that listen in today. So take it away.

I love to hear about you and how you got started. Sure. 

Suzanne Vyvoda: Sure. Well, melody, it's a pleasure to be here, Suzanne Voda and I've, um, I've had, uh, 20 plus years now working in clinical trials. Clinical trial operations, and I think some of what makes my background a little unique is that I started out as a clinical research coordinator, so I've spent time on the site side.

I had. Time on the CRO side as well. I went from site to CRO and then to sponsor. So, um, what makes my background unique is that I've had to sort of see how this industry works from those three different vantage points. Um, and so my approach to things, you know, I really try to lead from that 360 degree view.

You know, what is going to, um, you know, what is happening, what is. What is the CROs standpoint, and then of course, you know, folding that back into the sponsor. So I've now been on the sponsor side for. Uh, 12, 15 years now or so. I've worked at big companies. I've worked at teeny tiny startups. I've led teams of, uh, people across the globe on massive phase three clinical trials.

Mm-hmm. I've done first in human trials, of course, that are much, much smaller, um, and, and a little bit of everything in my, in, in between. And I think my, my ethos to that has been, um, to, to try to have experiences are that are broad based, so. Site CRO sponsored? Yes. But different therapy areas, different types of companies, different um, phases of trials, uh, because they all bring up different operational challenges.

And I'm definitely one of those operations nerds that really leans into the opportunity to solve unique challenges in clinical operations. 

Melody Keel: Yes, and I think that's exactly what got us on the same kind of plate per se, because both of us are very heavily knee deep in operations and I think we both consider ourselves, um.

Experts in ops as well as solution providers. We fix things. We take care of the challenges, and I have a feeling for me the same for you. When there's an issue, there's a challenge, there's a problem. You get called to come in and work it out and come up with a way, a viable solution that's not only. Fixes the current issue, but it's sustainable and gives us practical, uh, ways to move forward and not continue the cycle of the same issues over and over again.

Suzanne Vyvoda: Uh, it's such a good call out melody because that's one of the things I actually like to do the most. It's one of the things I would consider a superpower. Um, I think one thing that tends to get lost when we think about clinical trials is we have so many different stakeholders. We have sites, we have CROs and other vendors.

We have sponsors, but really. You know, coming all the way back to first principles, our North Star should be the patient. Yes. And I think for all of us working in clinical trials, we know that we know that that patient is, is what we should be focused on. But all of these different stakeholders have different angles of looking at that problem and therefore different ways to attempt to solve it.

And what we often miss is opportunities to bring all of those stakeholders to the table and think collectively about how to move a trial forward. Um, these different viewpoints can really get in our way. You know, the site doesn't always know what the sponsor is after the CRO sometimes gets this middleman position where they're trying to please everyone.

If we don't stop and think about how we'll work together as a team, then, I mean, not just as cross-functional teams right within each different group, but really as a team across the entire trial. That's where we often see this chaos that, that you and I have kind of leaned into here. 

Melody Keel: Yeah. Um, and unfortunately, I think most of us in operations are too familiar with chaos and it.

It starts from, if this makes sense, before the beginning. A lot of times we think we're at the beginning, but we really aren't. And so rethinking how we start and when we bring the stakeholders in and how we communicate and make sure everyone understands, um, each perspective and what the goal is. What are our.

What is most important? What is the North star for each of us so that we can work together? And so I would love to kind of understand how you calm the chaos, because we all experience it. It leads to so many things. I mean. It touches all the challenges that we find ourselves in with many of our trials.

Um, the people issues, burnout, um, quiet, quitting, and folks not really committing themselves because the chaos is just so overwhelming that they kind of give up quietly. Sure. And so there's just so many pieces to this chaos that we can prevent. Right. We totally can prevent 

Suzanne Vyvoda: Absolutely. 

Melody Keel: That continues to to happen.

Suzanne Vyvoda: So there's a couple of things that come to mind here for me. Melody, and, and obviously we have a lot of different cases, scenarios that, that we look at, but if we start at the very, very beginning and we set our trial up right, you know, this is the ideal. Time to have those conversations before there is a final protocol.

You know, when we talk about, or when you mentioned beyond the protocol, that, that brings up so much for me because I think of that protocol as that true foundational document for our trial. But the reality is so many of our stakeholders often aren't even part of the development process for that document.

Very true. And, and, and we're, we're operating off of something that, that may have been finalized. We're now reacting to it. So already, if that's the case, we've set ourselves back because if, if we're reacting to it, and by we I mean the sites, the CRO or even the operations team at the sponsor or other functional groups at the sponsor, we're already behind the eight ball.

In terms of, you know, how to come, uh, you know, come to the trial without that chaos. Um, my belief is that the earlier we involve those stakeholders and the more proactive we are about having true relationships that are built. Before the protocol behind the protocol, during protocol development, then we can really arrive at a protocol that not only is operationally feasible, but that everyone has bought into, and by everyone again, I, I don't mean just everyone at the sponsor.

Yes. I mean the CRO, I mean representatives from some of the clinical sites. I mean KOLs, I mean patient advocacy groups. Yeah. I mean, really leaning into how many different angles there are to look at this protocol, and I know. That as A-C-R-C-I read the protocol one way. What is my job and what do I have to do?

And can I do it as a CRA coming into a site? It's okay, here's the protocol. What is the site doing with that? So it's really important to align all of our stakeholders upfront and, and that to me is how we reduce that initial chaos that can happen now. The other thing that happens, melody, is you have a trial that's been kicked off, a protocol that's been finalized, a CRO that's been selected, you know, uh, the train has left the station.

And that's a lot of, a lot of the, you know, we, we often see chaos when that happens too. Um. A lot of reasons for that to happen. Um, sometimes, uh, we have executive teams at sponsors who, you know, they're, they're out, they're raising funds, they need a quote, they go directly to A CRO, they get one, but they haven't developed any internal operational expertise.

Right. Um, uh, often we seek out some, some feedback from KOLs when we're developing protocols. But are those the people who are really going to be at the sites that are going to enroll the trial? Have we reached out to community sites? Have we reached out to coordinators? Uh, have we spoken with patient advocacy groups?

We, we look to KOLs as the experts and they absolutely are experts in their field, but they. They, they play a role in the execution of that protocol. Um, and then you have a CRO that's sort of responsible to be that first line of contact between the site, uh, and that protocol. But we, we treat training as static.

We give them, you know, hundreds and hundreds of PowerPoint slides and hope, uh, we hope for the best. And, and maybe we have some meetings here or there, but we're, we're starting off on the wrong foot. And so often when that chaos starts to build, it's quiet chaos. It's emails that aren't returned on time because we don't always know the answers.

To, to respond to those emails and we're having to escalate and troubleshoot and, and adjust Internally, we're being asked questions that we didn't think about going into it because we didn't take the time necessarily that we needed to really think through what could come up once that protocol was launched and live at a site.

Um, so the, the, the, oh yes, go ahead. Go ahead. Oh, 

Melody Keel: no, I was just gonna say you hit, uh, pain point for me. Training, I think training is, um, so overlooked from, from the beginning internally with our sites, with our CRO and vendor partners. Um, even realizing that many of our vendor partners that build for us systems and platforms and the tools that we use.

Oftentimes they don't get any training on the protocol, which is amazing to me. But we need them to build our database or the platforms and tools that our sites will use in support of, uh, implementing the protocol. So I think training is something that is definitely a bridge that is broken and the, it leads to a lot of the chaos that we have because we just overlook it.

And like you say, throwing slide decks. At everyone and getting them to do a read and receipt in A-C-T-M-S system or SOP system doesn't that, that just isn't training at all. That's right. 

Suzanne Vyvoda: That's right. And you know, I've actually written quite about, quite a bit about, uh, you know, the training systems that we have in place and how they're broken.

We really work off of an archaic, um, methodology and there are. I think some really interesting new technologies. Some companies that are really trying to solve the problem of training, and I'm really excited to see where that goes. But the reality is that we all need the same depth of training. We all need to make sure that we're looking at all of the different pieces.

I'll take your vendor example a step further. And that I know that some folks at some of these vendor companies, uh, they're tech companies, they have tech PMs that are brought in. They may not know GCP, they may not know clinical trial operations at all. So, right. Do we understand who's on our teams? Do we understand their background, uh, their education, their training, their understanding of.

Clinical trials in general, this specific protocol, this therapy area, there are so many nuances across all of these different things, and we make a lot of assumptions. We do. Um, and then there's, there's an issue of ownership. Well, if the CRO contracts with the vendor, uh, do they train the vendor? Does the sponsor train the vendor?

And do we even have a conversation about whose responsibility that is? Exactly. Exactly. Um, we sort of get on autopilot. We, we know what we need to do. We know that we need regulatory approval. We know we need contracts in place. Uh, we have all of these boxes that we check on our SOPs, but that's the issue.

SOPs don't equal. An operationally sound trial. SOPs don't get us through that chaos because they're static documents and if we're not reading them, if we're not following them, if we're not designing them in a way that fits what we're actually executing against, then we're leaving a lot on the table. 

Melody Keel: I fully agree with you, and I think the SOPs serve a purpose, but they don't serve the purpose of helping us run trials in an efficient, optimal way, and not even from a compliance perspective.

Because oftentimes we write the SOPs in such a way that they can be an interpreted, and we don't put ourselves into a box where we're consistently out of compliance. So to rely on an SOP to help us guide ourselves through what we should be doing, mm-hmm. It's just not a good plan. I don't have a better way to say it.

Just not a good plan. 

Suzanne Vyvoda: Yeah, that, that's very true. I mean, we have to look at the actual flow of work. Yes. And s and p is only as good as, you know, the, the, the workflow that it mirrors. And if, if your team can't or won't follow that process, well you're out of compliance already. But again. I'll take it a step back.

Are we using the CROs SOPs? Are we using the sponsor's SOPs? Sometimes the sponsor has some SOPs, but not all, but, but how are we defining what our operational process really is and are we clear on those details? Because oftentimes the answer no. As often though. That's exactly right. Yeah. And if we have a small team, that might be something that we can sit down and have a meeting about.

Think of a phase three trial where you have teams spread across, across the globe. You have cultural differences, you have language barriers, you have time zone barriers. Yes. It's really tough to make sure that that entire team. It's crystal clear on what you're trying to accomplish. Uh, we have conflicting timelines.

You know, the CRO is gonna give you a baseline. There are so many times that we're so quick to look at first patient in that we're not really evaluating if the timeline we're operating off is, is, is, is aligned with what our goals are as a sponsor, as a partnership or, or as a program. Um, so there are a lot of opportunities, but it really takes that solid footing.

Be before the protocol to really be successful. And if we don't get that. We then really have to kind of go back to basics. If we find ourselves in that spot of chaos, it's going back to the protocol, it's going back to the contract that we have with the CRO and maybe those subcontracted vendors. It's going back to the site.

And making sure that expectations are really clear across, again, all stakeholders. Yes. If we're not working towards the same goal, because we don't know what those goals are, that chaos is going to continue to swirl in the background and we're all going to wonder because we all come with our own perspectives.

Yes. So. Again, making sure that the sites are really crystal clear on what you want and they know how to do it. Um, sites have so many responsibilities. They have so many trials. They often have trials that compete with each other if they don't know where you fit or how to accomplish something or how to get it done.

They're gonna move on. They're gonna do the best they can with what they have. But think of how many documents a site has to to digest. They have a protocol, they have an investigator's brochure. A lab manual. A pharmacy manual, yes, the list goes on. Yes, they may have one person, a coordinator, who's responsible for making sure that all of that is executed.

And that coordinator, of course, has multiple projects. So we need to make this information easy to find, and ultimately that protocol is the North Star. For everything that trickles down from it. But there are so many opportunities during that process of, of additional document creation where gosh, we might end up with something that conflicts, and then how do we fix that?

You know, how do we, how do we stop that gap before we actually have a problem? 

Melody Keel: Agree. And I think, um, I know what I shout from the mountaintops from my perspective is, um. People, culture and processes and in that order. And I think sometimes, um, if we could get to basics and focus on that, it would help us tremendously because we all know at the end of the day, from our site staff perspective, our study coordination, our investigators, the sponsors, and the CROs that are able to have the least chaos and to be the most organized.

And efficient in how they conduct the trials and what they're asking the sites to do. Uh, those are the studies that get the priority. They get the focus 100%. And so I think it's a downstream implication when you operate in chaos and you don't find ways to fix that. And 

Suzanne Vyvoda: then, and the main reason, 

Melody Keel: the state that they're in, right.

Suzanne Vyvoda: The main reason I really think that ha happens, melody, and I 100% agree with you, but you have a CRO that has their own internal processes, their own internal SOPs, their own internal infrastructure, their own internal management system, uh, and they're operating to their spec. 

Melody Keel: And their silo. That doesn't connect to the sponsor silo.

Right, exactly. And then the sites are expected to support two silos. 

Suzanne Vyvoda: For one study. And so that's why 100%, and that's why I advocate that CROs and sponsors have to form partnerships. Yes, yes. The sponsor is ultimately responsible for the trial, and yes, the CRO is a hired service provider, but if we don't act as a team and we don't establish that team mentality and culture to your.

Point, which I just love that you called out culture upfront. Uh, there's always gonna be friction. There will always be lack of alignment problems to solve. But if we have that foundation and we trust each other and we know what each other is trying to accomplish and how we're going to go about doing that.

That decreases the noise significantly. Um, I really like teams to feel empowered to talk to each other, to break down those barriers. To get to know each other. Yes. Um, to understand who that person is beyond what their job title is. You know, there can be so much friction on calls between sponsor teams and CO teams, but that friction be that friction's there because somewhere along the line.

Expectations weren't managed, or weren't right, weren't, weren't lined out. Um, transparency is incredibly important and, and, you know, within sponsor teams, it's making sure that the expectations, uh, of. The executive team of the investors are managed internally as well. You know, your operations team with a sponsor has to work with the chief medical officer, with the CEO, with that internal team to manage expectations, and that's why I really advocate that number one.

Sponsor teams bring in operational experts early and operational experts that have a, a real senior level of expertise to really think about strategy. We don't wanna think about what could go wrong tomorrow because if it's gonna go wrong tomorrow. The problem already exists, right? You really wanna think way out into the future about what downstream could happen, and it, it does take some experience to be able to do that.

And again, to think about your stakeholders, how does this impact the CRO? How does this impact the site? And. Of course, as sponsors, we wanna deliver for our executive teams. We wanna deliver for our investors, but we have to be operating against something that's operationally sound that's feasible. Mm-hmm.

Budgets and timelines that we know we can meet. And again, that's why it's really tricky to just, of course we're of course, we're rushing towards first patient in, it's an incredible milestone, but the more important milestone, in my opinion. His last patient out. We have to get through that trial. Um, and if we're, if we're stuck on getting the first patient in and how fast we can do it, we may be missing opportunities to make it easier downstream to get to that last patient because ultimately we're not gonna conclude this trial until we have a data readout.

And that data readout is gonna define how. Clinical development program moves forward one way or another. We need to be focused on finishing the trial, not just starting it. 

Melody Keel: So I'm, I'm one of the reasons why I was really excited that, um, you agreed to join me and be a guest today is because you have, um, insight or perspective from the C-suite.

So from the viewpoint of executive leadership, you've been in those roles, you've supported companies and, and been part of the direction and strategy a company goes and how they run trials from that, from that position or that level. And so I wanna ask you, because this is a discussion I have frequently with colleagues and, and people that I meet in the industry.

What can our executive leaders do? The, the folks that aren't so close to the day-to-day operations and challenges, um, and they're, they're getting the output, they're getting the status updates, and they're keeping a pulse on how we're doing, and oftentimes they hear the challenges that are happening, even more so than possibly the victories and the wins.

So what can executive leadership do to help calm the chaos that we're talking about? What are some strategies and things that you feel that level can do to help ease these pain points we're talking about today? 

Suzanne Vyvoda: So there's a couple of buckets that I'm gonna call out here and, and some of them are gonna feel obvious, but we're moving really fast and they often come.

Uh, they often come, they, they often break down along the way. The first one is communication. Our executive teams need to communicate their expectations very clearly, but they also need to be receptive to feedback. Uh, sometimes there are barriers within trials, uh, where timelines or budget slip, and there are real reasons why this happens.

If we keep kind of bumping up our, against our executive team, we're, we're trying to fit a square peg into a round hole. So operations needs to be able to have those conversations with the executive team, and they need to be able to translate what the team is experiencing. The reality is execs are really busy and they're not in those weeds, so they want high level information in terms of what's going right, what's going wrong, and why.

What the downstream impact of that is going to be. So there are, uh, you know, they need to communicate with their teams. We need as much transparency across the different levels as we can get. Now I know that that is tricky and I know that sometimes that means slowing down to go fast, but making sure.

That the team, not just the team leader or the head of clinical operations or the CMO knows what, what is being asked, but that the whole operations team knows what's being asked and how it impacts them. You know, I think we, um, we can often be in our own little silos too. A CTM can be in a silo, you know, this is my work stream, this is what I need to get done.

But if they understand. How what they're doing impacts the overall trial, therefore impacts the company. They're gonna feel a lot more ownership towards what they're doing. Mm-hmm. And so I really like to build a culture of transparency and clarity to the extent possible. And then for the, for the execs that don't necessarily know the details of trial operations, you know, making sure that we can all get in a room and.

Provide that feedback that they need in order to sort of see what's happening and educate them as to some of the, the hurdles that happen. You know, a lot of our execs didn't grow up as, as CTAs and ctms. They didn't work at CROs. They're, they're brilliant leaders. They're brilliant scientists, they're brilliant physicians, but operations.

It's so nuanced and, um, you know, I think that's why it's so important that operations has a seat at the table, a seat in the room, and it's important that that operator can translate what is happening in the weeds to what an executive needs to hear and needs to see. And ultimately what they really wanna know.

Go ahead, melody, please. 

Melody Keel: I so agree with that and, and there are so many times that I have been bought in on the backend when things have gone really, really wrong. Um, and it's a result of decisions being made. Upfront and the ClinOps team, or representation or leadership from ClinOps wasn't part of those discussions and that strategy and decisions, right?

And so we assume that a process can happen like that, or it costs this much, or we only need these many people, or it's very simple to do X, Y, Z. And so we can have a first patient in, in 60 days because we've already done a similar study. And so the team can just wash, rinse, and repeat, and everything will be good.

And so I think what, when you say a seat at the table, that is, um, it's, it's so true. And oftentimes ops is overlooked. When the decision making That's right. And the strategy. And we're just considered the workhorses and we just implement, but we shouldn't just be the implementation team. We should be part of the planning and strategy.

And when that happens 

Suzanne Vyvoda: 100%, 

Melody Keel: there's so much better every time. 

Suzanne Vyvoda: 100% I have, I've had the luck of, of being surrounded by some really. Brilliant leaders who understand how important clinical operations is, and they bring you into the room, they help amplify your voice. Mm-hmm. And by doing that, they help make sure that alignment is there, that communication is there, and that.

That communication is, is upwards and downwards, and that we can fill in those blanks. Um, it's, it's great when senior leadership recognizes how much clinical operations has to juggle and to worry about and how nuanced it is, and. Even if they, they don't know those nuances themselves, again, making sure that they're having the right conversations with the right people.

Um, that could be a skip level, that could be the CEO meeting with the head of ClinOps who may be reporting to the CMO. It could be expanding the leadership team so that VPs or SVPs or heads of departments have opportunities to. They're going to also need to refine that presentation for an executive audience.

It is different to present to an executive audience than it is to present to, to folks that are in the trenches to your clinical operations team, to even the CROs team because those folks are in it. We have to translate that into sort of that high level, high level actions and high level consequences, but we also have to be prepared to bring those executive solutions.

They, they, they wanna know what's going right. They wanna know what's going wrong. They also want someone who can come to the table and say, here's how we can get ourselves back on track. Um, here's how we can do better for our next trial. And so that seat at the table, regardless of whether that person sits.

On the C-suite team or is invited into the room by that leadership team, right? That track, that culture of transparency, of communication is so important. You know, these clinical stage assets. When we get to the stage in our company where we have a clinical stage asset, all of these biotech companies, many, many of them are pre-revenue.

Every dollar is so, so critical that we think through how it's spent and where it's spent. Uh, we don't want change orders, we don't want pivots, we don't want to rebuild systems, but Right. Those changes that we may have casual conversations about over coffee may have really, really deep and expensive downstream impacts.

So, you know, the mo, the more transparency we can have across the board, the more communication we can have across the board, the more we can bring clinical operations into the room. Really give them that seat at the table will be set up for success. Better going into it. But when that chaos comes mm-hmm.

We'll have someone who is, is able to navigate the ship and is trusted to, to help readjust where we need to. 

Melody Keel: Agree. I agree. I think that, um, is so insightful, um, and, and a good view into what. Doesn't happen, but also what can happen, right? Mm-hmm. Um, so I kind of wanna wrap us up and take us down the road of asking you.

What does a high performing team look like to you? What, what is that? In a dream world, uh, where you have a great team and these folks are getting it done, um, in the way that can be a model for others to use. Sure. 

Suzanne Vyvoda: So again, I think the first thing is an ecosystem's thinking. It's thinking about the entire ecosystem of your trial, all of your stakeholders, everyone that is going to be involved in that, uh, and thinking about it.

As an ecosystem, thinking about partnerships rather than contracts with CROs, with vendors, with sites, and really thinking about being intentional about communication and transparency. We talk about building culture. Internally at companies and CROs, sites, sponsors, they all want great culture. But culture goes beyond the culture at the sponsor, the culture at the CRO and the culture at the site.

It's the culture of the trial. Yes. And we wanna build a culture of transparency of, of. Of, of communication, of, of real ownership. And we wanna empower our teams to feel like they are really part of helping move that engine forward. Um, I think that really making sure that the teams understand. Why the trial is so important.

What's exciting about the mechanism of action? What's exciting about the therapy area? What the patients that are experiencing this condition are really going through. Mm-hmm. And why it's so important to get better treatments to those patients. Why this trial? Why this team? Uh, you know, I like to make sure that the CRO knows how.

How amazing they're performing, why we chose them. I like those sites to know that we see them as true partners. I like to know who the coordinators are and the PIs. I like to make sure that when we have investigator meetings or times that we can come together in person, we're really able to shake hands and put faces to names and make meaningful connections.

People need to feel like the work they're doing. It's part of something. People are working in this industry because they want to help patients. They want to advance science and medicine, but if all you're doing is flipping one page over to the next and looking for i's that haven't been dotted and t's that haven't been crossed, it's hard to see that what you're doing really makes a difference.

And I think everyone needs to see that overall vision and feel like the work they're doing is really moving that needle. 

Melody Keel: I agree. I totally agree. Well, I think this has been an amazing discussion. I'm so glad you joined us today and um, I think teams can really. Pause. It doesn't matter where you are in the trial, if you're at the beginning or in maintenance or you're wrapping up, um, it's never too late to try to find a way to calm the ca the chaos.

Right? Um, and it's 100% true and, and try to. Try to try to make it better where we, we may have not, um, done as great as we could have, but there's always opportunity to improve it and make it better. And I think the things we've talked about today lend themselves to that completely. So thank you for joining.

Suzanne Vyvoda: My pleasure. I think there's always this desire to, to, to run, run, run to that next milestone, but sometimes slowing down and walking before we run is going to set us up for such better success in the long run. Yes. And I think if everyone feels that they have a seat at the table and that the work they're doing matters whether you are at a site.

A CRO, uh, a lab vendor or a specialty vendor at the sponsor, regardless of what your title is or what your level is, everything you're doing is incredibly important and incredibly meaningful towards, towards that trial and towards advancing that therapy. Um, and so if I could leave you with anything, it's that.

Wherever you are in your journey, what you're doing matters, and the better we try to communicate that value across the entire team, the entire ecosystem that's participating in our trial, the more success. 

Melody Keel: Absolutely agree. Absolutely. Well, thank you Suzanne. This was awesome. I'd love to have you back. I think we could continue this conversation for hours.

Suzanne Vyvoda: I think you're right, Melody. I guarantee you we could, I have so many notes here. Um, just thinking through, you know, the different things that we talked about coming to this table. Um, and you're right. Um, I'd be more than thrilled to join you again. 

Melody Keel: Awesome. That sounds like a plan. All right. Thank you.

Suzanne Vyvoda: Thank you so much. It was a pleasure.