Beyond The Protocol

Where Does Trust Begin in a Clinical Trial?

• Melody Keel • Season 2 • Episode 7

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In clinical trials, trust isn’t a soft skill it’s the foundation of everything. But trust doesn’t just happen between patients and sponsors. 

It begins with the teams who run the trials. Without strong leadership, mentorship, and ongoing training, operational cracks erode not only team confidence but also trial credibility.

In this episode, Melody Keel sits down with Cornelia Baumgartner, founder of Cetacea Clinical, to explore how mentorship, professional development, and team culture shape trust across rare disease, early-phase, and lean biotech environments. With over two decades of experience, from study nurse to strategist, Cornelia shares how clinical ops leaders can build resilient teams, embed trust at every layer, and position trials for success.

What you’ll learn:
• Why trust starts with leaders who mentor, train, and invest in their teams
• How ongoing professional development strengthens trial quality and culture
• The risks of misaligned outsourcing and the need for empowered internal teams
• The connection between mentorship, operational readiness, and regulatory trust
• Practical steps for sponsors to embed credibility without unnecessary complexity

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. 

If you found value in today's conversation, please subscribe, share with your network, and leave a review. 

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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This Podcast is Sponsored by The Research Associate Group, Inc.

Melody Keel: All right. Welcome back to Beyond the Protocol. I'm so glad to have you with us, and I'm even. Happier to have our guest today, Cornelia Baumgartner, who is the founder of Cetacea Clinical. And, um, we connected through LinkedIn, um, and we're on opposite sides of the pond. She's in Europe and I'm over here in North America.

But we just connected. I think we share a very similar passion about clinical operations and the industry that we're in, and I'm just really thrilled to have you on today. 

Cornelia Baumgartner: Likewise. Thank you for having me. Melody. 

Melody Keel: Yeah, so I think today, well, just to give everyone a little bit of background, uh, Cornelia and I kind of came together, realized we're on a similar mission, and we said, you know what, it would be good to connect every month.

And so for most of 2025, I've had the pleasure of meeting with Cornelia every Friday morning, once a month. And we have these very in-depth discussions about how to save the world in terms of clinical research and, um, keeping patients first, but also making sure our processes and our teams that are conducting the work to run the trials that they have, the support and training and mentorship.

Strategy and framework and all the things in place so that it can be done successfully. And so I thought it would be great to carry that conversation over to the show and let others hear and have insight because I think many of you will definitely relate. And be able to understand and feel, feel the power of the mission that we're all carrying.

So, um, I, I do wanna give you a chance to introduce yourself because I think you have a very, um, interesting journey into clinical research, just as most of us do. And so you started out as a nurse, so tell us a little bit about yourself and how you landed. 

Cornelia Baumgartner: Yeah. Um, as Melody said, I'm a, a nurse by training.

Um. I've worked only one year as a nurse. Um, and then I somehow stumbled into clinical research first as a CRA very classically in, in Switzerland. Um, I, since I speak Italian, French and English, I was the and and German as my mother tongue, and I was obviously the right person for the job and I loved it so much today.

More or less just decided to stay. There was never a way back in the hospital, so to say, I, until I have kids. And then I went back to the hospital as a study nurse or study coordinator. And I think that was also very interesting to see, uh, struggles from the other side. Um, how life it is, how life is there, what they appreciate, what they need, and um.

Uh, I was also able then to, to, um, finish a diploma of advanced study in clinical trial practice and management. That was in 2012. And since then, I'm mainly working for, um, small biotechs around the world. Um, mainly phase one clinical trials in oncology or, uh, infectious disease. And then three years ago.

Um, I decided to, to open my own company to balance a little bit the risks in small biotech companies or not. Uh, they, they have like, sometimes they run out of money and other times they have safety issues, whatever. So, um, I thought to balance a little bit the risk, I open my company and then I can work for two or three clients simultaneously.

Yeah. Yeah. 

Melody Keel: No, I think it's really interesting and I always, um, am appreciative of everyone's journey and the different sides they may sit on throughout their journey. So you've been, um, on the CRA side, so you had that view, but then you went and you sat on the other side of the table and took on the study nurse study coordinator role.

So I think it's, it's, it's really insightful when you have. Worn multiple hats. And it just gives you a level of empathy that, um, oftentimes if you've only been in one side, if you've only been a CRA or you've only had a sponsor, or you've only been, uh, a project manager at the CRO, not to knock it, it just gives you a different level of dimension when you've worn.

Different hats in different roles. So I really think that's cool. And I'll have to say, um, many of us know we did this clinical operations at SEA Conference here just recently, and I'm, I'm coming down from the high of that. Um, but what was really cool about that conference was sitting in the room. With so many different roles and players from sponsors, CROs, sites, vendors, study coordinators, crass, project managers, CEOs, all, all the different folks that sat at that table when we were together.

And it was really interesting to see and hear the pain points for one topic, but all the different pain points and experiences from the different roles. So I think that really gives. Um, you this amazing, um, kind of dimensional approach to how you help startups and smaller companies. We've talked about this in depth with risk management and understanding how this impacts the sponsor versus how this may impact the site and why we need to mitigate risk or, or, or take a different approach to this problem because of this.

So I think that's really insightful and I would encourage people to try. To put themselves in the shoes of the roles that they're supporting or working with. Right. 'cause it makes a difference. 

Cornelia Baumgartner: Yes. Um, you know, when I think sometimes it's, it's forgotten. But we all have the same goal. We all have the same goal to bring the study forward, forward, to bring a drug to the market to help the patients.

And when we not work together, then. We just make our, our lives worse to much 

Melody Keel: more difficult than 

Cornelia Baumgartner: they much more faster. Yes. It's really that way. And what I hate to hear is, is sometimes they say, oh, all CRAs CROs are that way or this way. And, and so against that, because I think. It's their job to do the, the clinical trial.

Our job is to help them do the clinical trial, and if we start working together, rowing in the same direct direction, it makes our lives so much easier and to study so much better. It's the why. They need to understand the why and, and we need to to move forward as a team. 

Melody Keel: I agree. I agree. And I think, um, a big piece of that is not even an, it's not an intentional, we won't work together.

It's just the way that we set ourselves up and we find ourselves in a silo. And so I'm the sponsor, I do this. I'm the CRO, I do this, I'm the site, I do this. We focus on, um, kind of the broken lines versus trying to shore up and, and, and take away the silo and just be a collaborative group. I think that would help us if we could find a way to do that and kind of open up our doors and come outta the silos that we work in every day.

Cornelia Baumgartner: Yeah. And the success will give us, right? It's, it's, um, for example. When I am working on a protocol, I always make sure that I have a CRA, the CRAA study nurse. Mm-hmm. Having a look at the protocol and this for a simple reason, they know the patients, they know the status, the patients were in, or they know their facilities.

So if we say in theory it's possible to have the blood wrong and five minutes later we have an E, C, G take. That may work for us young, healthy people, but if we are old ill people that may be difficult. And then we have protocol deviation over protocol deviation, something that would be so easily avoided, avoided high by having.

By having a study nurse, the one who is doing the work, the one who is knowing the patients, just to have a look at the protocol and say, yes, that's working. Or Ah, maybe that's not the best approach. 

Melody Keel: Agree. And I think sometimes because again, the silo and everyone is focused on their part. You know, as a sponsor, the protocols.

Created, approved, finalized, and all the, all the folks that contribute there are responsible for that document that drives the entire operations of the study, right? What we need to accomplish, but we forget to include the folks on the other side of it that have to execute it. So wouldn't it be great if we, again, opened up our doors, stepped out of our silo, and figured out a way to bring the end users, the site staff, the PIs, the study coordinators in.

Um, and it not be like a rush thing, oh, we're almost done here. Read it. Tell us what you think. But to actually have them from the beginning to say, I could never accomplish getting that done in the way that you're writing it, but I could do it this way. Right. And I think that would, that would just help us streamline so much better.

And it's not rocket science, but it's so hard to implement and to do that. 

Cornelia Baumgartner: Yeah. Well, shouldn't be hard, I mean. 

Melody Keel: It shouldn't be. And I think that's where a lot of our conversations lead when you and I speak one-on-one is about the training and the processes and making sure everyone's informed not just on their role, but how the other roles come together.

And we all make, we all are parts of a total sum. And so if I don't know what you do and you don't know what I do, how are we gonna get to the finish line? In a way that doesn't look like chaotic, stressed out, everyone's hair is on fire. 

Cornelia Baumgartner: Which other thing is like if we do the same and we don't know that you're doing the same.

So we, we just waste, um, availabilities. We waste our power to do things and that's. Yeah, it's, it's too bad. I, I always think it's communication is building trust. Communication is building clarity. And I don't think you can over communicate with somebody. 

Melody Keel: No, no. Absolutely not. And I think, um, I think we're just so focused on the end goal that we forget there's, there's, there's definitive steps to get there that if we just stop for a moment.

Um, and take a step back. It may take us a little bit more time on the front end, but we can get to the end zone in a more clarified, clear way. And we might even get there sooner. Like I know I've experienced studies where I've been fortunate enough to have leadership that gives us that time, right? That we need to try to do things in an orderly, concise way where we can think front to end and, and work backwards.

Um. Those studies. Honestly, every time we we've delivered, we haven't had like the craziness, um, that so many other quality issues come up. And you're backtracking and you're redoing, you have to update databases and change CRS because we didn't think about this and now we need it. Um, but when we're able to really think it through.

I've had a, I've had a couple of studies where we, we ended early, we pulled our timelines in early. We locked the database, we closed sites, we were done. Um, and, and everyone's just like baffled that it was possible, you know, but it really is possible. It doesn't have to be as hard as we make it. And, um, I think the word trust that you said is really key because, um, if you trust the people that you're collaborating with.

To be able to communicate effectively, to be able to think things through and understand that unrealistic time, timelines in time zones, um, and deliverables, uh, won't work. And that we, you, you can't just push, push, push, push and expect a positive outcome without, um, without consequences. 

Cornelia Baumgartner: Yeah. Well, you know, I think pushing is okay, but then you need to give a reason why you're pushing.

Sometimes I feel sponsored and um, I need to take me into that group. They are pushing, pushing, but they don't say why. And, and when you give the why, when we have reached that milestone, we reached the next or we received the next milestone payment, and we need the money to continue to study. These kind of things are, are important.

You know, it's also important for the site, it's important for the, uh, CR oin know, and oftentimes that's, that's not them and right. Other aspect that I think that was lost, um, during the pandemic. And, uh, I'm sorry that that has not been taken off again or not yet as much as it was before, is the personal interaction.

Yes. So if you meet face-to-face in person from time to time, you simply build another relationship then. I mean, it's, it's great talking over, um, zoom and, and all these, uh, digital formats, but still it's not same. It's 

Melody Keel: absolutely, I mean, that's even true for you and I, we've been on Zoom for almost a year now.

Right. And we are saying we have to get in touch. We have to meet, we're one of us is gonna fly and we clean and meet in person. I agree. It's so important. And across the board, not just from the perspective of investigator meetings, but even internally, uh, with your internal teams to have everyone come together and be in a room together for a day or two.

Um, and you may be discussing the exact same things you would virtually, but you get such a greater value from having the human in-person connection. And so it just seems like you leave. That meeting in such a different way than you do when you just push the button and end the the zoom call or the team's call.

Cornelia Baumgartner: Yeah. And what do you do? Mostly when you end the call, you go to grab a coffee, a glass of water, whatever, and maybe your, your connect does the same. So you're standing in front of the coffee machine and you're talking, you're chatting, be it the family, what you have done the last week, and, uh, which book you're reading, which movie you, you watched, whatever.

But that gives like, it's bonding. It's personal bonding, and you need that. Depends. You have a child that is sick or you have to care for your ill mother, whatever. Then I have a certain understanding that you're not available between three and four because you have to do this or that. Yes, 

Melody Keel: yes. And compassion and empathy is able to come in.

To the situation so much easier when you've had an in-person human connection. And I've even had, um, team members, like, after you've worked together for a year or two and then you finally get that opportunity to have an in-person meeting or offsite, whatever it may be. I've literally had people say, you know what?

I actually like you,

and I'm like, well, I didn't realize you didn't like me before. But I also know I can come across as, um, I, I, I'm kind of quiet and reserved and I may not speak up unless. I feel it's value added. Um, and I'm also very known to be by the book. Um, I know the regulations. I know how we should do things properly, and so I'm usually the one that's pushing back when we're trying to do something, I'm like, that doesn't seem like a good idea, or are we thinking it this way?

I can see how people could kind of put me in a box of, you know, maybe not approachable, but then when we're in a room together, they're like, oh, you're not so bad after all.

So there is value to human connection, and I agree. Post COVID five years out. Right. Why are we not getting together? Why are we not putting the investment in that? Because there is a considerable ROI for bringing your teams together, whether it's investigators, sites, sponsors, vendors together, or it's your internal team, whether you're a CRO sponsor, psych, put the money in and do it.

It makes a difference. And I think the agenda and the topics and, and the needs that are. To be discussed. They have such a bigger impact. When you do it in person, you can't do it all the time, but it's worth, it's worth it when you can. Um, so given what we're, what we talked about so far, share with me how you're helping companies, um, with solutions to some of the issues we've discussed today.

How are you going in and providing support, um, because I know how you're doing it, but I think it would be great for others to hear your approach and your perspective to how companies can benefit from the type of services you're providing. 

Cornelia Baumgartner: Yes. So. I think what, what, um, or where I would start, um, when I, when when I enter company and, oh, it's, it's always a bit different, different since, since the companies are at different stages.

But let's say if the company is about to write the protocol, then I certainly make sure that we, you write the protocol as I said, that we include the different parties that we have. For example, uh, a statistician that looks over there. The, the, the protocol that we have, the investigators having a voice in that we can, that we can bring in the c the study nurses to, to tell us what it is.

Also, I mean, nowadays everyone talks about patient groups and, and having them in that they can voice in, that's also important. Maybe not in the phase that I am working. So phase one, two, it's, it's not yet that acute, but. Still important to think about it, but at that moment, I still think it's the doctors, the investigators, the study coordinators that can like advocate for their patients.

And I mean, they know their patients and they, they want the best for their patients. So, and then another topic is to select the right vendors. Um, when you're a small team. You don't need to go with a, with a big CRO if you have like a small local study and you don't have to choose A CRO or a vendor that can bring you from phase one to phase four, but you always need to focus on the study that you have at hand.

And the vendors must fit the study. And yeah, and it's also, for example. As we discussed in person, how many companies do I see that don't want to make bit defense meetings in person? They say, oh, let's do a video call. And I'm so much against it because you can see so many more things if you're sitting in the same room.

As an example, once I had the, um, a bit defense meeting and the medical director or the medical, well probably medical director. He was almost sleeping on the table when he wasn't in the spotlight and, and he was like lying there, almost lying and perhaps on his, on his cell phone. So I thought, okay, that's not the way or not how he should behave.

Or you could feel if. The team present at the defense meeting is really a team or a random group of people who happen to work in the same company. Um, so, so that's, that's kinda makes the difference that, that we choose one or the other. Because the budgets are mostly aligned. They, they seem to have a benchmark where they, they fit into, but the in-person.

Interaction. Interaction. You can, you can see during such meetings is telling a lot. 

Melody Keel: Yeah. Yeah. And I think that's the benefit of having, um, a consulting company, someone that has the expertise and the viewpoint. Um. The insight that may be missed. You know, like planning a bid defense and you go out and you get proposals from multiple companies and you look at them, they're all spread out, and you say, okay, we're gonna go with A, B, and C, and then bid defense.

And you just, it's just going through the motions. And then you just kind of have some criteria and it's just kind of like, oh, well we've worked with them before, or this is the lowest price. Or you know, you take the three and the go with the middle. It's just kind of like a random. Process. Right? It feels very random and, and you've lost the strategy and really digging in and deciding who is best for this study.

Yes. Or from where we are at this time point in our company. And I think having expertise that understands that and the downstream implications is important. And that's just one example, right? There's so many other ways, like when you're planning out a protocol or you're choosing vendors or what technology to use, um, it's just.

So many different sides to it that are often overlooked because we have a protocol, we need a study team internally, we need site selected. Uh, we need IRB approval and we need the first patient in. And that's all we're really kind of focusing on, and we're, we're losing all of the things that make those very important deliverables successful.

Right. Yeah. 

Cornelia Baumgartner: You know, I think. At Satia, we have a setup process, how to do certain things and how to document it. That's, that's on top of it. So, um, if you say the strategic approach, yeah, the strategic approach of setting, selecting the right CRO, for example, that's one part. The other part is you need to document.

And that's often not done. But if you have a process in place, um, like the one I have, um, at Satia is like at the end just collect the documents. You put the meeting minutes together and you file it and it's done. And if you had five years later to go back and say, okay, why did we choose that zero or who.

Who took the decision to choose C? Yeah, I was documented. And that's also what, um, I-C-H-G-C-P is telling that we need to document our decisions. 

Melody Keel: It seems so simple, right? It seems so simple. Like hearing it, you say that it's like, duh, we know that. But I also have experienced where it's not documented anywhere.

All the team that started out in the beginning is gone and we can't answer the question. We can't recreate the storyline. We have no idea because the very simple thing of just documenting went away so it wasn't done properly. And so again, I think just having that kind of solid. Engagement from an expert who thinks of the things that may not be front of mind at this time point, but they sure will be needed at the end.

Cornelia Baumgartner: And also for the documenting process. One is forgetting so much the details and it's the detail. Details are the grain to the, to the soup. Like it, it's adult to the soup. Sometimes we had cases like we discussed four and backwards example safety cases for weeks, and you were so much into the details into the topic and you thought, I'm gonna remember that for the rest of my life.

And then two weeks later, you dear and say, okay, why? Yes? How come that decision and. 

Melody Keel: The detail is lost and then you get a very superficial overview, but the meat is gone. 

Cornelia Baumgartner: Right. And you know, that will the things that probably makes, makes the difference If you have somebody who has led like 40, 50, or hundred of studies Yes.

And make with mistakes and lu through this first eggs, then having somebody who is fresh. And, and leading the first clinical trial, they can do a perfect job in project management, but maybe they, they hit some of the rocks we had. Also hit, but we probably wouldn't hit anymore. So yeah, it, it certainly, at least consulting, you know, that Yeah.

Somebody in the background you can ask or somebody just like overseeing the project. Doesn't have to be too much hands on, but it's guiding and, and also training. Training on the job for younger people, for junior people too. 

Melody Keel: I, I mean, I, I, I feel like I'm yelling at from the mountaintops here recently, how important it is to train and support our teams and make sure mentorship is in place and we're doing more than just checking.

Right? Um, again, another component that makes a considerable difference. It's often overlooked. So I fully agree with you and I think, I think, um, we have a lot to do, a lot more work to do, right? Um, but I, I hope that the folks that listen today, um, agree with us and feel. There's very simple things we can do.

We can implement. They don't have to be very expensive, they don't have to be super challenging. Uh, you don't have to wrap them in a lot of bureaucratic red tape, right, to get them pushed through. There's just simple common sense things that we can do and bring our perspectives and our expertise in, um, to make our operational processes in getting us to the end zone for clinical trials So much better.

Cornelia Baumgartner: Yes. And in regards to training, I, I think it was, uh, Richard Branson who said, if you're not, um, investing in your employees, then your business is lost. It was something like that he's saying, and I very much liked it because if you're investing in your people, they pay you back. Oh, the how would you have what?

What you invested in them. It's the trust, it's the training, it's the, you know, some, sometimes you hire somebody for a job and then probably you think, okay, I hired this person too. Let's say make the coffee. But then you see, no, this person makes so delicious sandwich and B. Why is it enough to say, okay, it's not the coffee, it's the, the sandwich.

Sandwich. Exactly, 

Melody Keel: exactly. If 

Cornelia Baumgartner: you invest in them, 

Melody Keel: if you invest in them, um, they will invest in you and the business and the work to be done. 

Cornelia Baumgartner: It's just that I think we're, yeah, they're loyal to you. They stay, they, they support you. They support. Your business, your brand, and, and that's the employee at the end you want to have.

Melody Keel: I agree. I agree. Well, it has been lovely to have you on the show today and to have this discussion. Um, I think we could carry it forward for probably another three or four hours or so, but I'm so glad to have you on the day and, um, we will definitely be in touch again soon. 

Cornelia Baumgartner: Yes. Um, so we have some. Ideas of, um, ideas, projects we could do together.

And, um, I would love to do them and, uh, I'm sure some of these project may even result in, in another talk, um, to get you. Yes, absolutely. Absolutely. I was, I was just saying if, if anybody wants to connect. Satia Clinical for either quality management system processes or on my websites. There are some eBooks and my papers with very practical insights.

Then please just reach out to me and, um, I'm happy to help. 

Melody Keel: Awesome. Thanks Cornelia. Glad to have you here today. 

Cornelia Baumgartner: Thank you for.

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