Webinar: Aligning Operations for Clinical Excellence

Nearly 70% of FDA clinical trial inspection findings are tied to documentation and procedural gaps that could be prevented with better operational coordination. Clinical trials succeed when processes aren’t an afterthought—they are integrated for efficiency and quality. 

In this panel discussion, clinical and technology leaders will explore how agile trial management can reduce risk, improve inspection readiness, and accelerate timelines. Hear real-world insights from both sponsor and CRO perspectives on building proactive, cross-functional practices that work.

Join us for this live webinar where we will cover:

• Strategies for maintaining GCP & Inspection Readiness without slowing down

• Building scalable processes across sponsors and CRO partners

• The role of connected systems in enabling visibility and accountability

• Cultural and organizational shifts that support quality-driven trial execution

View the full session or read the transcript below!

Full Transcript

Kevin Tate: Thank you for taking time to join this Kivo webinar. If you're watching a recording in the future, thank you for your future time. We're excited to be here. I've got a couple of great panelists today and we're gonna be exploring all things clinical trials with the theme of how do you make sure you align operations, systems, and your teams for clinical excellence. First a couple of housekeeping notes. Please do ask questions. We've got a Q&A feature in the webinar. We've also got the chat channel; either works. Sarah and I will be monitoring those and we're happy to take those along the way or address 'em at the end. This session is recorded and we'll be sharing a copy of the recording with everyone after the session, so you'll get that as well in a follow up email. And I think that's it. With that, I think we're ready for our show. I'm so excited for this one. First, thank you. Thank you, Travis, for being here.

Travis comes from True North. True North is a Kivo customer and partner.

They're a contract research organization that focuses on ophthalmic studies. We've been working together for some time and had the chance to work with the True North team, both on their own internal quality and training and processes and using Kivo's TMF and clinical solution for their client work. So that gives us a lot to talk about. And so thank you Travis, for sharing a little bit about what that experience has been.

And we've got our own Sarah Ruiz. Hi Sarah. Sarah runs our clinical solutions here at Kivo. She works with all our customers and partners like True North and comes from her own clinical trial and operations experience. Maybe that's an interesting place to start. Sarah, how did you get your start in this?

Sarah Ruiz: That's an interesting story actually. And it's funny because my husband still to this day is like, "what do you do?" It's only been 10 years.

I actually started as a patient. I'm a type one diabetic. I grew up in New Smyrna Beach, Florida. And I was actually like laying out on the beach, getting a tan with my insulin pump. And I was approached by a clinical research coordinator who was like, so sorry to disturb you, but we have a clinical trial. It's for this device. It was an oral medication that didn't get passed for type one, but did get passed for type two, which is cool. It was a 10-day overnight study. I was bartending at the time. I had my associate's degree in math and science, so I was like, sure. This is interesting. Yeah, so I started as a patient and then I spent enough time there to be interested and meet everybody and made my way to working at the site and all things site, including regulatory management, business development lab, like pretty much all of the hats. Then I pivoted to clinical trial technology and started working at tech companies, CROs, a little bit of drug development.

Kevin Tate: Cool. I knew you had experience on all sides of the industry. I'm not just saying this because it's a webinar. I didn't know that story. I didn't know that's how you got your start.

That's great.

Sarah Ruiz: Yeah, it's unique.

Kevin Tate: What about you, Travis? How'd you get started in all this?

Travis Holman: I'd like to be able to say that this was always my goal, but it was not.

Kevin Tate: Standing up as a fifth grader saying, a fireman, but I wanna be...

Travis Holman: 20 plus years ago when I was in college, I was, thinking about going to be a physical therapist or a doctor and, you name it, anything science related. And I had a friend who after he graduated, got into clinical research I the wheels started turning and eventually he talked me into that. And I've been there ever since.

Kevin Tate: History and context is worth a lot here because there's a lot of pattern recognition and things that are same trial to sponsor, sponsor, but it's always a little different, right? And so figuring out what's the same and what's different over time and how do you be prepared for that? It's the theme of our webinar today.

So maybe just to tee things up a little bit, and then I'm gonna hand it over to the experts.

I've been thinking about this phrase a lot recently for a ton of reasons. I can't figure it out. It sounds a little bit like a blessing, but also a little bit like a curse or a threat. But it does seem apropos. And I thought of it here. Because it's certainly interesting times in the world of clinical trials. And especially how those trials are managed through the teams and the systems and all the processes and the documents that go along with them. So just to frame things a little bit and things that folks on the webinar might be seeing in their own lives.

Sponsor teams are under different types and pressure and market forces than they've ever been under before and are all feeling that in different ways. I think CRO and trial management teams have always needed to bring a mix of excellence and consistency and efficiency. Not just to win the bid and win that trial, but also deliver on that trial and grow with that customer. But all that's changing too, right? I think everything's speeding up and everything is fragmented than it was even four years ago.

And then overall, the technology that sits at every different part of this- whether we're looking at the the sponsor side, at the document side, the CRO teams, the actual project and process management, or all the way down to the sites- all that's moving super quickly. We could pick any number of technical themes and they would all start with "it's different than it was even four years ago".

So this is a really interesting time and backdrop, I think to enter trials and to tee them up for success. So given the experience that you two are bringing, part of what I wanted to explore today is if you were talking to a team that is now preparing for a trial... it's probably not their first trial. They've probably done this before, but this is maybe one that, like a lot of them, trying to figure out how do I do it the best way this time? What do they need to be thinking about or what tips would you offer when it comes to things like clinical excellence aligning teams, selecting and using the right systems and processes. And then also things like once you've got all that ready to go, how do you keep things on track? And how do you make sure that -should you need to be inspection ready- you are. And then also looking to the future.

So we're gonna explore a set of these topics and also share some examples. I think, a lot of the folks on the call today are Kivo customers and friends. Hi. Good to see you. Thank you. Thank you for coming. So I don't need this to be a Kivo commercial but we'll but we'll use a couple of examples that Kivo and True North use together to just illustrate some of these points too. Does that sound right? Sound good, Sarah? Sound good, Travis?

Travis Holman: Yep. Sounds great.

Sarah Ruiz: I was gonna say, you can almost just rewrite that quote to "Man We Live, you May, you live in interesting times."

Kevin Tate: Yeah exactly. Good news! You do. Yeah. It's that's right. It is.

Start here. Back to our theme Clinical Excellence, which is a good one for this whole process. Starting with you, Travis. I don't know. How do you think about that?

How does that play into what True North does? What's your take on our theme?

Travis Holman: Yeah. So for clinical excellence, first of all I'm an operations guy, so you know, all of my answers are gonna be coming from that lens internal operations.

So for me, clinical excellence starts with building a company culture that, the quality is always intentional and is always the first thing you think of. That goes into, the backbone of everything that you do, your quality, your SOPs, quality control, which then gets into your subject safety and your data integrity. But it all starts there. It starts with having quality be intentional and the backbone of your program. That's something that I'm sure my team is sick of hearing me say. But I always tell them that quality is everyone's responsibility, not just the QA manager's responsibility. Every single person that we employ is responsible for quality at True North.

Kevin Tate: Nice. I like the snaps on that, Sarah. And the cultural angle, right? If it's part of how you are and why you are, then it's not a, I don't know, annoying checklist to come back to when you have to. Does that ring true for you? Sarah? What's your take on this?

Sarah Ruiz: Yeah, absolutely. It's really easy to set aside. There's just such a large amount of tasks and subtasks and dependencies when you're starting a clinical trial from the startup to the maintenance to the closeout, that it's easy to treat quality like the redheaded stepchild because it's quote unquote slows things down. But what's really the reality is that you're not setting yourself up for success with quality. And you're gonna run into roadblocks time and time again. And next thing you know, you're months away from your original trajectory with enrollment, with finalizations of plans.

I completely agree. This question in and of itself should be the first question that you ask when you're establishing a trial. It's like, how are we actually defining what are our, not to sound incredibly corporate, but what are our KPIs for this trial and how do we partition that out from our for business as usual practices to what this trial specifically needs.

Travis Holman: I think for me the clinical excellence is gonna come from that. So that's gonna be the output of your backbone of quality. It will be, what did my site audits look like? What did my sponsor audits look like? What did you know, how clean was my data? Did my product get approved by the agency? That's how I'm going to see if what I established was able to deliver on my clinical excellence. Because that's how we're gonna be as a CRO.

Kevin Tate: And is that something, Travis, that you talk about with a potential client even upfront? I'm curious how, if and how this theme comes into your conversation with a sponsor when they're trying to figure out, if True North is their partner, et cetera.

Travis Holman: Besides budget, I would say that our quality process is probably the most important thing. That's why we get audited by sponsors and, they dig through our QMS and our SOPs and all of our processes. Because at the end of the day, they're signing over some responsibility to us.

So they have to ensure that our SOPs are up to par and that we're gonna, do right by their trial.

Kevin Tate: And digging through those SOPs is fun because they're in Kivo!

Travis Holman: It is much easier that way.

Kevin Tate: Which makes a ton of sense. And we'll come back to this point on the process side. The way you describe the role of quality is very different than some tax that must be imposed and maybe paid at some point in the study, at the detriment to your schedule. Instead it's infused in the way things are done. And there's some of that's cultural. And then we're gonna touch on some of those things that are more process and system related too.

So that seems like great tee up.

As we move through and our topics will kinda broadly align with, before and then as you prepare and then during these studies I'm curious to, to explore.... When you've got a study ready or you're gone about to start one. Don't have to tell you... there's a lot of animals in the zoo. There's a lot of people coming to the table around this thing, and they're coming from pretty different teams, right? At the minimum we've got the sponsor team, the trial management team, whether that's internal or CRO. And then we've got folks at the sites, but it'd be easy to draw a diagram with all the other people that are interested in investing or watching or consulting. This is a bigger problem than it might even sound like on the page. Maybe starting with you, how do you align those How do you get those people on the same page and keep 'em there?

Sarah Ruiz: I'll answer with a story. So I think one of the, one of the key things, especially like even in your RFP for trial or in your bid defense essentially what vendors are gonna be needed for that trial. But maybe your go-to pharmacovigilance vendor doesn't service the country that this trial will be conducted in. So you have to find another one. It's really easy to just go get the quote, do the thing, and then forget to submit the vendor for qualification on your quality side. And then you are, backpedaling a lot to make sure that vendor actually qualifies to onboard them onto this trial.

So I think with that said

Kevin Tate: That's an example. Not that that actually happens.

Sarah Ruiz: That never happens, right? Yeah. That never happens.

So I think when we're talking about like best practices- and Travis touched on this already- but like making sure that your SOPs and your work instructions and your team are aligned on how things are meant to flow from the get. From the training.

So you would know, "okay we're bidding for this new trial. We have these vendors, these are our qualified vendor lists. I know that I need to add a new vendor. That automatically triggers a vendor qualification. So there needs to be operational and systematic workflows that align with your needs consistently throughout the process.

So I think that, and regular checkpoints with broader teams. I think, you have this study team that you started with your project manager and your CRAs, your monitors, things of that nature. It's really good to involve a quality person in those study meetings as well.

Kevin Tate: We'll come back to this when we look at some examples of reports and and some of the project management stuff, but yeah, to your point, it goes beyond just the systems. It's like actually getting the people aligned and the right types of responsibilities.

Travis, how do you think about this? You must have to deal with this again and again as trials come and go, right?

Travis Holman: Herding cats is the term that we always use. I don't know if that's just a project management thing. Obviously working with CROs, Sponsors...everybody is facing different pressures and everybody has different priorities and they all might not be aligned. And that can even happen internally, if it's just the sponsor running the trial. Data management is working towards different milestones or goals. The monitors are working on multiple projects. In-house CRA team; same. Aligning everybody is a challenge for every study. But I think that communication is key there. Easier said than done, but for us, we just like to establish a very clear communication plan with thought out escalation pathways and, making roles and responsibilities matrices. Just to make sure that everybody knows "Hey, this is the part I play, this is the expectation for me." So nothing is surprise. But this is a challenge for every study.

Sarah Ruiz: To echo off of that Travis. I preach project plans and decision trackers until I'm blue in the face because clinical operations is gonna be like one of the biggest projects that you've ever faced in your life. There's so many different moving parts. As you said, there's so many different teams. There's your biostats, your data management, your safety, your monitoring teams. But they all have to work in tandem with each other. I'm a huge fan of master project plans with attached more digestible baby project plans based on the roles and the responsibilities. That way, what dependencies are, what your risk to your timeline is as you have to move things on inevitably. it's more of a when things go sideways than if things go sideways because it's just too many variables to control.

So I think that decision tracking... like you could say, "why did we build IRT that way?" And it was like, oh, we agreed that was the best spec. And it's when did we agree? That's where your decision tracker comes in. Because you are not gonna remember what you decided three days ago let alone three months ago. So I think those are two really important tools, would be project and decision tracker.

Kevin Tate: And the those play, I think is even more important. Because one of the things that has struck me- and I've spent my whole career bringing software to teams, trying to get things done in different industries, and spending the last few years in life sciences- it strikes me that A) everybody's super busy, but B) everybody has at least two jobs. Nobody's life seems to be "I'm gonna sit down and work on the same thing I worked on yesterday all day again and I'm gonna do it again tomorrow." And so when they finally get a chance to sit down, like, "Where are we with this thing again? What's on fire? What's next?" Having everything be super structured and super ready and super clear. Just means even more.

And I think goes without saying, but the last three or four years and the way work has changed and gotten more distributed... a lot of it is happening like this on Zoom. All that makes that even more important. So I think, yeah, to your point Travis, it makes alignment. Something you gotta of live every day and through every project. I like that. I like that. And we're gonna come back to the what happens when things go sideways because I'm sure you've just got some magic wand things there that you wanna share.

Travis Holman: It's a new thing. New thing every day.

Kevin Tate: Following our journey here, I wanna talk a little bit about systems. There are a bunch of different systems we could talk about. Here we're gonna zoom in on the TMF and the process management around the TMF and the trial itself. Kivo has solutions for that. We're gonna show a couple of those screenshots, but also, we're not getting into real site management here. So patient billing and scheduling and all those things, those are typically other systems. But we have had a chance to work with an awful lot of teams now on managing their TMF and their processes.

Travis, I know the way we met was you were looking at a system like this and trying to figure out what was the best fit. What was that like? How did you decide what to choose?

Travis Holman: It was a long road. I think I reached out to 10+ companies at least. Obviously what you're looking for internally... Initially, everyone has to have compliance standards, right? Like we 21 CFR Part-11, you have audit trails, you have version control. So once those boxes are all checked, then I'm looking for usability and flexibility.

We are all working in a lot of different systems. To me, if I can cut down the amount of systems to have my team trained to and familiarize themselves with, then I am removing a barrier in their day-to-day work. So I was targeting an eTMF that also had a lot of other solutions for things that were a problem for us. And you guys happen to have a QMS, an LMS. And if I can bring one solution to my team that tackles, 75% of our problems, then that's gonna be easier for the team to digest. Everyone's gonna be working in there. Even if they don't live in all of those different modules of Kivo, there is still that familiarity of using the system. I just wanted to make it easier for my team. And that's how we landed on you guys.

Kevin Tate: Yeah. Then thank you for that. And and I think a lot of the folks on the call use several Kivo modules for different parts of the business. I hear a lot about that from just a budget standpoint. Hey, it just makes more sense and we wanna make the most of our budget.

But I like how you brought up just, fewer systems and less training. I guess back to just the dynamic nature of especially this part of the business, people are coming in, going out. You've got trials starting, trials ending, and if there's a grinding of gears every time they have to learn a new system or go through some complicated training, that just makes life harder. Thank you. That's a great thing to highlight.

You've probably worked with a bunch of different TMF and process management systems. What, I don't know, how do you think about this part of the puzzle?

Sarah Ruiz: First of all, doing your due diligence and looking at a lot of different systems is definitely the way to go. And also Travis's approach is exactly what I would do is just like listing out your basic requirements and then your niceties, right? What's gonna be the biggest impact on your team from an operational standpoint? A morale standpoint, no lie. And also a budget and scalability for your business.

I have worked in a lot of different TMFs. It's hard to say that there's a 'bad' TMF especially Because all of the TMF vendors we're very nice to each other. So there's that. But I think what really is important is making sure that somebody on that vendor side speaks your language. That's going to be imperative to making sure that once you are quote unquote "live" in the system, that you feel comfortable, you feel confident. You're not just the champions of the system, but also the people that have to use the system every day. And this is very important for the QMS but exponentially more important for the clinical because you just have more hands touching things and more shift of documentation. Sometimes I call it the human change control, right? How much of an impact how quickly can I get my team up to speed in a new system while still running these trials? Because it's very rare that you're gonna not be running a trial at the same time.

Kevin Tate: You don't get like a four month break to retool and just get everything ready and then come back? Yeah, exactly. How does that sound? Summer, maybe?

It's a great point because there are a lot of the basics or table stakes around the management of TMF documents that are gonna be common across systems. One of the things that I know is common across really any team's "jobs to be done", if you will, is you gotta figure out how to get all the documents from all the places, put them somewhere that they can be seen, controlled, and managed in a compliant way. And then you need some set of reports and things that help you make sure that's happening, right? And feed into your overall trial. Those of you who use Kivo's clinical module know this is how Kivo thinks about it. You kinda drag and drop, drop stuff in from anywhere, and then you manage things in our folders and cabinets, and then we've got a whole bunch of different projects and reports.

I'm curious, Travis, how do you think about this as a business process around the TMF? And just thinking about how you make this efficient, but also stay compliant and report-ready. This is a particularly, important part of all this. How do you think about it?

Travis Holman: Staying compliant, obviously we have to be audit-ready at all times. But for me, part of that- and it's a feature that you guys have that was a requirement for me- is the reporting. I need a smart TMF that can give me live updates on what the health of the TMF is. Obviously we're gonna do annual or biannual audits depending on the project, but myself and the sponsor, they want to know in real time, what does the TMF look like right now?

Kevin Tate: I think I have a shot of this report somewhere. Yeah. Here we go. The completeness report. Yeah. Okay.

Travis Holman: So I can't answer that confidently if I don't have something like this, because I'm waiting to do a full audit of the TMF and then I can respond. But as somebody who spent most of their career being a project manager, I need all of the reports. I need to all the KPIs. All of the information that I can get is vital to me. And especially now since I don't get into the weeds on all of our projects, this is something that I can look at in five minutes and have a pretty good understanding of where we're at, and any progress that we've made. So I can say to a sponsor or somebody else in my company, " This is where we are. We're starting a study closeout." I feel confident in where we're at and this is what we need to do.

Kevin Tate: I'm curious do you make use of the Kivo placeholders?

Travis Holman: We do. Yep.

Kevin Tate: For those who haven't seen Kivo placeholders, like any company that uses placeholders for this, it's just a nice way to pave the road of the full TMF and also pre name things and preset metadata and be able to assign them so that you can run a report and say, "where am I versus done?" And it makes it all a little bit more knowable.

Sometimes our clients will use those placeholders as a way to also gather documents from site staff or CRAs by assigning them to upload those. But also some don't some, back to this picture, just say, email it in, or drop it off here and we'll put it in.

Is that consistent across your projects, Travis? How do you handle the gathering of documents?

Travis Holman: Our first project, we were not doing that just because we started up so quickly, but we've started to establish all those processes. We keep all of our document collection internal though. We have our monitors or in-house CRAs file everything. So if it's a document that just comes in through email.

Kevin Tate: Got it. To your point, it's gonna be all these things. And so trying to figure out how do you keep it trackable. We get that question a lot, right? People wanna see how easy it is to upload stuff in a Kivo and see how placeholders work. And they say, "Ooh, should I just add 150 accounts for all my site staff and have them all upload things into here?" And I tend to make a sound like "maaayyyybe", but it depends on what that's like. Maybe start with something that's more hybrid and make sure that the site's gonna be ready for that.

Travis Holman: My preference is to keep it internal. I just feel like the site is also navigating a lot of systems, even more so than a CRO or sponsor because they are using sponsor's systems, TMF, everything. We are going to be more comfortable in there. We are gonna understand our processes, our QC control, where documents are supposed to go. It is just cleaner that way. So my preference is to allow the sites just to email us the documents and have the internal team file everything.

Kevin Tate: I'd say that's what we see most often. It is often an internal team. It's not one person who is like "I am the human modem trying to get everything into the TMF". Exactly. It makes it easier to handle that.

Hey, we got a great question that I'm gonna try to do justice, and I know Sarah you're excited to answer this one. So the question is, look, this is all expensive. TMF management in particular, and as sponsors try to control those costs, but also be compliant and use e-signatures in a compliant way for part 11. I guess the question is, in the future do you see a more risk-based approach being applied to the TMF and its associated documents and compliance approaches? Or is that right, the right way to look at it? Sarah, thoughts?

Sarah Ruiz: Yeah. I'm reading the question now. So is it truly needed to demonstrate the story of the trial in the future? I think when we're talking about part 11 compliance... For TMF, the signature is a fairly new concept. Electronic signature. Typically you're getting that outside of the system and you just need to attach the addended documentation to show that it's part 11 compliant. With Kivo it's a little bit different because we can draft, edit, and route documents, whether it be a recruitment plan or CSR in the system itself. So we pride ourselves on being a start-to-finish documentation management system for TMF.

When you're talking about archiving documents at the sponsor level, let's say just like True North, your CRO is managing your TMF and at the end of the study, you're extracting that. There's gonna be some contradicting opinions here. I still think that you need an auditable system, a fit-for-purpose system. That's very much emphasized in Revision 3 of ICH E6. Gone are the days where you get it on a CD and then pull it up. But there's also agreements you can make with your CRO for okay, you're gonna archive our TMF for the next 15 to 20 years and we have a communication plan for if there's an audit . So we come to you, we have this, we do all the things.

When with risk-based approach, it's very... it's a little bit up in the air. I think that it will bring it forward. I think the definition of what's truly essential compared to the clinical data will change from trial to trial. So what's truly essential for a phase one ophthalmology trial is not necessarily truly essential for a phase three dermatology trial. It's not a fun question to ask because it's going to change. And I think the guidance put together in ICH E8 and IC eight and ICH E6 helps you understand and identify in the beginning what's critical to quality. Because that's what's going to be your guide, that's what's gonna define what's essentially in your documentation throughout the clinical trial. And that was very long-winded.

Kevin Tate: It's great, Sarah. Great answer. And well above the pay grade of the moderator, so thank you.

Also I think what you said in there is is the fact that these documents start in Kivo start in the TMF and get worked on and finalized in the TMF makes all that a little easier. It's not like you're doing it over here and then deciding how much tax do I pay to get all this in the TMF? Which I think is a different hurdle. Excellent.

Sarah Ruiz: Just to shamelessly boost Kivo for a second- data transfer agreements. Those are a essential part of a trial when you have, when you're working with a EDC and data management vendor and a lab vendor and a pharmacovigilance [vendor]. I always tell people, use Kivo Corporate as your data transfer, as your SFTP. Give your vendors access, have those folders. And then as needed, they can be migrated into the TMF. But at least you have a clean, concise place for your monthly data transfers or whatever the cadence you agree with. And you can literally draft and execute those transfer agreements in Kivo.

Kevin Tate: And for those who may have missed it- this little corporate icon, which perhaps you can see in the Kivo interface here, that comes with the Kivo system. And basically it's just a secure DMS for you to put stuff in, manage access, maintain compliance, and you can use e-signature there.

So to Sarah's point, we're seeing more and more people just use that as a place for compliant documents that don't necessarily have to be in the TMF, say. Yeah, it's a great point.

I wanna come back to this one, which we alluded to earlier. Best laid plans and all that. Everybody's aligned, everything's wonderfully managed and on track until it isn't. How do you mitigate that and how do you keep things on track when all the surprises come? Travis, you wanna take a stab at that one?

Travis Holman: Yeah, I'll take this one. So we'll go back to one of the the key terms that the FDA and agencies are throwing around right now, and that's just risk-based approach. To me it's all about preparation, right? We have to put in a solid risk management plan. All the teams try to foresee what your pitfalls for this study are gonna be using lessons learned from other studies, from everyone on the team, from data management, to stats to project management and have that be as well thought out as possible. Obviously things are gonna come up that are outside of that, what you establish risks for. It's all about preparation for me. If you've established a good risk base or risk management plan, then I'm gonna be prepared for most things that are gonna come my way in one way or another.

Kevin Tate: That makes sense. Yep. I like the idea of seeing around corners and being as prepared as you can. I can't help but ask if either of you have stories that come to mind of where something just totally out of left field happened and yet everything was okay. Any question.

Sarah Ruiz: I'm trying to figure out how to tell this story without incriminating...

Kevin Tate: you're gonna need to do plenty of redacting. You can just redact as needed. Yeah.

Sarah Ruiz: I'll start with saying that a lot of the surprises that come happen during study visits. Where you're like, "I wasn't expecting this outcome" or "I wasn't expecting this decision", whatever. In line with what Travis is saying as far as trying to outline risks and then mitigate those risks before you get surprised, I would highly encourage sponsors and CROs to get study design input early from your principal investigators. They have more insight than you can even dream of [into] how they interact with their patients, the way that their patients live and interact with the world. All of these things are really important because yes, we're conducting research, but we're conducting research on people and people have a lot of stuff going on. So there's that. But yeah, I mean there's so many things can happen.

One trial, a massive phase three trial across multiple countries, and we ran outta lab kits, manufacturing issues. It was during COVID, so as we know in a lot of different industries, supply chains were interrupted. You have to think, what do we actually need? Like we need to collect the blood. We need the lab to process the blood. Do we have the right tubes that aren't expired? Do we have the labels that can make sense of it? How can we work with the lab? So whenever you are surprised with something, you have to take a step back. Put one foot in, one foot out, do the hokey pokey and figure out what's the end goal? What's the timeline? How is it going to interrupt things? How do we fix things? Is that fix feasible? So there's a whole series of questions you need to ask yourself, and the team needs to come together and answer to figure out what the end-all-be-all solution is, or if there even is one.

Kevin Tate: I like the combination of, see around corners up front and then embrace the creative problem solving when it's required. With my systems and compliance hat on, you've got to make sure that when that happens, it doesn't show up to an inspector like, "what happened over here?" Instead, it's very clear, this is what happened. We did this analysis, we had this deviation, we did this. Like everything's documented and so on. And keeping those systems easy enough to use, that can actually happen and not be like a forensic exercise six months later and trying to remember what do we do with those tubes? All sounds very relevant.

Sarah Ruiz: I think that there's like a general fear of failure especially when it comes to inspection readiness and things. When I was at the site level, I used to, train my CRCs to say a squeaky clean visit note, whether that's a paper source or electronic source is, and having be one of the highest enrolling sites and have every single visit look completely squeaky clean is just as much of a red flag.

Kevin Tate: Oh, that's interesting.

Sarah Ruiz: Documentation is everything. Things happen. Catching it first, documenting it every part of the way is going to be your saving grace when it comes to an audit. Because if the documentation doesn't explain the error, the correction, and you know the plan moving forward, then you have to do it in person. The whole goal should be that your documentation speaks for itself.

Kevin Tate: There's a theme here that's come up a couple of times. We talked about keeping things on track, we talk about keeping things compliant. It's back to the herding cats of the whole project management piece. So I wanted to talk a little bit about that. Because as with all these areas, I think that's a place where the tools available to manage projects and integrate them with the processes and documents are changing very quickly.

So here's another example again from Kivo. A lot of folks on the call will recognize this. This is our project management interface. We launched this fairly recently and it's been popular with all kinds of teams. Regulatory teams use it to manage their content plans for submissions. Quality teams often create little project plans for things like vendor audits or deviations. In the case of trials, we often see these project templates aligned to things like selection in startup or an interim monitoring visit or study closeout and so on. Sarah you put this one together and I know it's be become popular with some of our clients. Tell us a little about what's going on in this kind of project management approach.

Sarah Ruiz: The beauty here is that you are not going into a separate tracker just to mark something as complete. This is a very document-centric project plan. So every task relates to a document. If you were able to scroll down, you would see that every placeholder is linked to a task. So you can see here that we have your general checklist that you're collecting from your site, the 1572, the financial disclosure forms, the CVs, all that stuff. But you can literally file those and it will mark those tasks as complete as you file them. Which is huge for sources of truth, right? Because if it's not complete here, it's not filed, and you're saving yourself, several minutes and even more clicks to get to an answer that you want to just ask and answer yourself.

Not only does this help internally track, but this is such a key part for sponsor oversight. Because one of the biggest things when I was living in that world with your weekly check-ins is going through those metrics and site monitoring is huge. Your CRAs are the backbone of your study. They're traveling almost every single day going to these sites, doing remote visits. They're keeping track of a lot of stuff. So this helps everybody stay aligned on where's what. With our template function and our being able to draft and collaborate, you don't have to worry that some monitoring visit report is stuck in someone's local files or local folders. "Oh, yeah. I sent it in an email and I don't...' you're literally starting and finishing in Kivo, which I think is where you really unlock a lot of value.

Kevin Tate: That makes a ton of sense. And Travis, I'm sure you've used N number of project management tools, and I know you're looking at the, some of the things Kivo has now. I don't know any silver bullets for managing these types of projects?

Travis Holman: For me, getting this out of an Excel tracker and into an automated system that is more controlled is the answer for me. For so many years it was, our startup trackers and Excel document. We might be using a CTMS for some functions. But there were trackers everywhere. And, anybody could access them and change them and, are they being updated? It goes back to understanding where your trial is at all times and being able to answer the sponsor like, "Hey, we're this close to startup, or this is where we're at." And being able to trust that answer. So to have a system that tracks it outside of Excel, which is what we had been using for such a long time, is a breath of fresh air for me.

Kevin Tate: Got it. I'm glad to hear that and look forward to seeing how how you incorporate this one and yeah, you're not the only one. I feel like I'm, as everybody's managing their lives in Excel still, which is great.

I wanna get to a great question. Thank you for submitting it. And also our last theme. We know there's an overall risk-based approach theme to E6 R3, but outside of that framing are there any important takeaways or specific things for this conversation for R3 versus the way things worked in R2?

Sarah Ruiz: And I actually pulled up my notes from our June webinar for this

Kevin Tate: Fair. Webinar reincorporation is allowed.

Sarah Ruiz: Another shameless plug, if you guys gonna wanna go listen to me drone on about revision three to the point where I can barely breathe. I think that the important, major changes is that revision two really included an integrated addendum, so it was more of an integrated addendum to revision one. So a lot of embedded things. It's still encouraged that like the implementation of like more improved and more efficient approaches to GCP. And they had some minor updates to standards for electronic records.

Revision three is really grounded in that foundational principle from ICH E8, which is quality by design. It involves a lot more critical thinking, which I love because this is a industry that definitely requires critical thinking. It is a lot more proportionate and risk-based, just like we said. It's really important to identify those risks and then outline how that, what that approach to that risk is. And it really recognizes that one size does not fit all.

Beyond that, there's some more subtle shifts. There's 11 principles of GCP spanning five full pages, which are really detailed. It's a lot. Revision three is like a lot more digestible as a document to read and understand. Revision two has two pages with 13 principles and they're cross-referenced each other.

Revision two does not truly acknowledge the use of electronic formats where revision [three] does and also gives guidance for electronic formats, which is lovely. And then there's like specific guidance for CROs in revision two where the shift from two to three is, is more of a language shift where just labeling CROs as service providers, which allows you as sponsors to cherry pick different providers to help facilitate your trial.

Kevin Tate: Of those themes and takeaways, the one that I've heard most often in my conversation with sponsors and service providers is this quality by design. And they said, we're getting asked or we're being advised that an inspector, an auditor is going to ask about quality by design and want to see that reflected in our plans or in our systems or in our KPIs. Maybe it's things that were already there, but they should have that nomenclature or maybe it's new things that we wanna put in place. We've worked those into some of the the reports in Kivo and the way we surface those. I like that thing, quality by design. Sounds good. I like that. Sounds good.

Travis, anything from R3 that's changed or that you had to prepare for you're doing business?

Travis Holman: I agree with almost every, everything that Sarah said. The big emphasis is risk-based quality management, quality by design. For us, it's about proportionality. Reviewing our risks, accepting some risks, then choosing action on others. So it just gives us a little bit more flexibility to work in the real world. We just have to be more intentional with it.

Kevin Tate: Got one more question from my side, and then we'll see if any other questions come in from our studio audience. Again, either chat or Q&A. We'll see those pop up.

My question is, we haven't talked a lot about the sites today. Obviously, in a very real sense, that's where the rubber meets the road in these trials. I know it's always different and depends on trial instructions and format, but any thoughts on to work with sites through this lens of efficiency and compliance, given the realities of how differently different sites work and that they have a little bit different relationship a lot of times to the sponsor in the project?

A big topic, but thoughts on that through the lens of consistency, compliance, and clinical excellence? I know, Sarah, you wanna tackle that easy question first?

Sarah Ruiz: I can take all six minutes. No, I'm kidding. Yeah, I think what really having worked at the site, ran a site, ran a major site network it's to use Travis's project term. It is like herding cats at times in the best way possible. It's just a lot of different people with a lot of experience and maybe differing opinions. So sometimes it's easier to keep it simple and it. You should respect the site's own operating procedures. Getting everybody on one system can be very hard at the site perspective. You're already adding a new EDC, adding a new IRT, maybe you have a payment system for the patients. It's really important to ask the question and get your sites involved on, "this isn't the ideal scenario, is it realistic?" It's balancing those scales because if at the end of your investigator meeting your sites are like, "that sounds hard", then maybe you didn't make a good decision with your systems. And it would've been more cost effective and operationally effective to keep it simple and allow people to do what they know in their own systems.

The struggle with that is integrating the data at the end of the day. It's really where you're wanting to, or where you have the resources to split up the work. There are a lot of really powerful site tools that are catered to sites, that are managed by sites. What's important as sponsors, as CROs, as vendors, is to take a look at your integration capabilities add those integration capabilities in your decision making spec for vendors. And then working with your sites to see what they're willing to do . Are they savvy enough to do it? I hate to say it, everybody comes from different walks of life. And if it takes a week for this site to train [but elsewhere] it's four months and this other site doesn't get it... It's not that site's fault, it's just different walks of life. There's a lot of questions to tee up that you should answer. If it's a five site trial, then it's probably a lot easier to get them all in one system and work through that and have collective meetings to train and keep checking in on them. If it's a huge trial with a ton of sites, then maybe it's not as feasible. I always wanna push the ideal. But you have to reel it in a little bit.

Kevin Tate: Be realistic. And pay attention to what's working.

Sarah Ruiz: Be respectful to the site's decisions as well. You pick them for a reason. They have a process that works for them. It's very highly possible that interrupting their process will slow down the promised timelines.

Kevin Tate: For our last minute, Travis, I wanna ask you what you're thinking about for the future. True North is having a lot of success. You've been proactive in how you're thinking about technology and growing the business and delivering studies in a new way. I'm just curious, what do you see for 2026? What are you thinking about as this space continues to evolve?

Travis Holman: There's a lot of conversation about AI right now. That's the, that is the hot topic.

Kevin Tate: There we go! There it-

Travis Holman: So obviously I have to be... there's a lot of AI companies that are getting involved in research that are doing the full spectrum of things. I'm testing those out and seeing what works in practice and what is not gonna work. It's hard to trust a new technology sometimes. I'm just doing a pilot of, it's not an actual study, but that takes a lot of work.

For 2026, it's navigating that. And then for just True North as a company, scaling and growth. It's a good problem to have, but it's also something that, I'm trying to be very thoughtful about. If you scale too quickly you're gonna have, your issues are going to be highlighted. I'm thinking about using AI for scaling, but those are all, problems for 2026 Travis.

Kevin Tate: Exactly. We got months still. Congratulations on your continued success. And thank you for that. You very well may have given us our next webinar topic: lessons learned from working with AI in this space.

Thank you to both of you for your time. This was great. A lot of fun. Thank you. Thank you for joining us. Thank you for attending. Again we'll be sending out a recording for any of those of you missed it. Take care all. We'll see you next time.

Sarah Ruiz: Thanks everyone.

Travis Holman: Thanks everybody.