Quantified Site Performance: The Metrics You’re Missing

[Gary]

Welcome, everybody. Most of us today operate in a world where we rely heavily on actual clinical trial data, the lagging indicators, in some cases, qualitative data to make decisions about trial operations, site management, and trial outcomes. Today, we're gonna take you through a presentation and a webinar where we're gonna talk about the shift to leading indicators and quantitative data to better informed decision making around site performance and trial outcomes. I'm joined today by my colleagues, Ger Sweeney and Nigel Hughes. We're gonna touch on three core topics.

The first is a deeper dive into what we call site performance and quantified site performance metrics. We're gonna take a walk-through, a detailed walk-through of our live environment so you can see how this data-driven approach is enabled and the 360 view that you can get as a sponsor, as a study team, and also the impact this can have in terms of our thinking about trial operations as we shift to this leading indicator approach and this quantitative over qualitative approach to trial management.

The key thing for me and for our team here when we think about site performance is, yes, adoption, usage, interactions with our platform are all very, very important. But if you look at the bottom right, really everything we do, we count towards the impact of trial outcomes. When we think about engagement, most people will think today about site adoption. And I reckon every vendor you've worked with will always talk about site adoption, sponsor of choice, sites love us, and, you know, we have great adoption as well across our platform and always have had it.

For us, the real metric that you need to be looking at is what we call Monthly active sites. This is sustained and repeat engagement month on month throughout the course of the trial. For us at Teckro, we consistently see north of seventy percent monthly active sites and site engagement.

This has a profound impact on trial performance and trial outcomes. So much so that very often, we see upwards of twenty percent increase in randomization rates. We see upwards of ten percent acceleration in time to Last Patient In on a trial. For us, engagement is the leading indicator of performance.

On a trial we worked on a couple years back, and we came in mid-flight on the study, it was in a rescue scenario. The study was not performing to, to plan. This is what it looked like before Teckro became involved in the study. Post Teckro, non-engaged sites on our platform actually got worse. Their performance continues to deteriorate over time. What was interesting with the Teckro approach, the sites engaged through this platform, they actually saw an increase and acceleration in recruitment, so much so, it was north of twenty percent and had a huge impact and effect on that trial.

When we think about site performance. And, again, if you look at the way of the world operates today, we tend to look at sites in a very linear way, or very binary way. Either they're performing or they're not performing. They're either high recruiting or low or non-recruiting sites. And this kind of mirrors our approach to everything we do in clinical trials. We tend to talk to sites with one voice via email or via newsletters.

We have to make blanket decisions about days on-site. Everything is preplanned, and we look at the consequences of those actions further down the trial. With Teckro, we try to paint a very different picture for sponsors and for study teams. We look at performance metrics, in this case recruitment, but we look at that through the lens of engagement and what that means for your study. And that's given us a very different view of site performance and trial outcomes.

We've built what we call the Site Performance Quadrant, and later in the presentation, we'll take you through a live view of this. But just to take you through the concepts behind this, and some of this is quite self explanatory. Obviously, the bottom left quadrant, you know, little or no engagement with your protocol, with your study, and obviously not meeting, or not recruiting, what's required for the study. Top right, high performer, highly engaged with the study. Lots of visible interactions with your protocol through Teckro, but obviously, meeting or exceeding recruitment expectations.

And then the top left is a very interesting segment. Without Teckro, they would just look like low performers or non-performers on your trial. With Teckro, you get this view of this segment, which is really interesting because they're displaying all the same characteristics of a high performing site. For some reason, there might be some friction, there might be some local issues, it might be a timing issue, it might be something with your protocol. For some reason they're prevented or they're blocked from making progress in recruiting patients. Without Teckro, as I said you wouldn't have this view of these sites. With Teckro, they're now potential performers that can be enabled to become high performers.

I talked about the sort of 'one size fits all' approach, whether it's email newsletters or monitoring days on-site or other resource allocation activities that happen throughout the course of a trial. And very often, when you look at newsletters, there'll be a league table or recruitment league table showing the top recruiting sites. That's a great message if you are a high performer and a top recruiter. It creates a sense of competition between the sites. But it's the wrong message to send to a low performer. They're not looking at your protocol. They're not interested in your study, or they've lost interest in your study.

They're not offering your study to potential patients or participants. And so the way to communicate with those sites is very, very different. The goal is to engage them with the trial, get them to understand the rationale behind the trial, why this drug and why the study might be a good opportunity for their patients. And hopefully, over time, we can get them to engage with the study and then move them from low performer to potential performer, potential performer to high performer.

The goal here is to move sites through the quadrant. It's a very segmented approach. It's targeted interventions. It's understanding where your sites are at and having the right approach and the right interventions to move the sites through the quadrant. The goal here is to measure everything, not just through engagement, but through the impact engagement has on trial outcomes. And so what we're trying to do is reduce the number of low performers overall, or at least give you the data that would point to maybe the decision that needs to be made to shut these sites down sooner.

We're trying to stop looking at potential performers as maybe problem sites and see that they're highly engaged and potential contributors to your study, but we need to go deeper into what's happening at that site or what's blocking that site from being successful. We want to keep high performers highly engaged throughout the study, continue to contribute at that high performance level. And for offline performers, they might be performing in the study, but you don't know how and you don't know why. And it's in your interest to bring them online so you remove any risk, or doubt, or any blind spots from what's happening at those sites.

I just want to take you through a couple of quick examples, and I know this all might seem conceptual, but my colleagues will take you through the live environment, you'll see all of this is real, and how it comes to life.

This was again, another rescue study that we're involved in, an oncology study. The study had been up and running a number, I think, six to nine months before we got involved. They were struggling with recruitment. After one month of Teckro being involved, we're able to segment the sites across the quadrant the way you see it today on screen. And so they had reasonably good engagement after months. Almost seventy percent of sites were engaged. Thirty five percent were in that high performance contributing category.

What was interesting in the space of a couple of months, again, through that segmented approach, that targeted approach, to site engagement and site performance and trial outcomes, we were able to move a number of those sites through the quadrant like I described earlier, the low performers reduced and moved into potential performers. Potential performers became high performers. And overall, there was a thirteen percentage point increase in high performing sites. And so that's a huge impact on the trial. If the average today is about thirty percent of sites produce most of the valuable data and recruit most of the patients into a study, to even go five percent faster, or increase up by five or ten percent. And this just a very early example of Teckro in use. We could see a thirteen percentage point increase within a relatively short space of time.

Maybe just to bring you up to speed with a more recent example, and this is just the evolution of this approach and working with a sponsor who's been engaged with us for a long number of years and has been really engaging this approach, for the last two years in particular, well-adjusted to this methodology and way of working.

Really rapid engagement out of the gate. They got up to close to ninety percent of engaged sites, within the first month of the study going live. What was interesting was the impact after three months. And again, you see that positive movement from low performers to potential performers, potential performers to high performers. And if we think about high performers, and, again, I'll mention that thirty percent industry average figure that you regularly hear, to get to sixty percent of your sites performing, You know, you're going twice as fast. You now have twice the number of sites recruiting patients, highly engaged with your study, and you've also got this potential performer pool which could still contribute as the trial continues to progress. And this is the goal we're starting to set in Teckro for every study we work on and with every sponsor, is that, you know, sites get engaged in studies because they want to contribute. They want to create greater opportunities for their patients.

This is about engaging those sites positively, enabling those sites to do their best work, and ultimately contributing, in a very targeted way to site performance and trial outcomes. For us, that targeted, segmented approach to site management, targeted interventions drives engagement. Repeat engagement, and that seventy percent metric I talked about at the start, that's key too - repeat engagement, it drives repeat, increased performance over time. Very last example before we start to move on.

This is again an example of a study where we've been working with the sponsor for a considerable amount of time. And I know these numbers that I show might seem unbelievable. In many cases, you look at them, you go, wow. How can you get to that? But this is the power of this approach of targeted engagement, of repeat engagement, and a consistent approach to site performance. And you could see the difference between sites who are offline or not engaged, with sites who are fully engaged and managed through this process.

Just to lead into my colleagues and the live demonstration they're going to take you through, just how we achieve this. For us, as I said, communications is a key part of what we do. Targeted communications; you're talking to sites at the right time with the right message relative to where they are in the trial. Contextual, targeted messaging drives increased engagement with the protocol, directs focus.

When we get sites into the protocol and they're using it through Teckro, we're able to capture a rich dataset, and also, obviously, as they engage with the protocol itself - we're able to capture sentiment, feedback, survey or feedback loop questions, comments, queries outside of the protocol, all can be captured through Teckro. And this rich dataset is fed through this 360 view we now present, this novel suite of dashboards and data points that can give you a unique view of how your sites are performing today. That in turn drives this data-led performance segmentation into this Site Performance Quadrant view. And that in turn allows us to repeat the cycle again with more targeted, more contextually relevant messaging to drive repeat and increased performance over time. So really the goal with Teckro is fast feedback loops with your sites and to create this flywheel effect, if you like, of sustained and increased performance over time.

All of this is enabled through our interconnected digital platform. All of these interventions I talk about are enabled through the platform, and we'll see that now shortly, as we go through it. So, again, just to wrap up on my part of this presentation, this is really about understanding where your sites are at, looking to leading indicators of site engagement and site performance, quantitative data that allows you to make better-informed decisions, to make them faster in the trial, to have real impact in terms of trial outcomes. And the goal here is really to drive performance, in a targeted way. A digital-first, data-driven approach is really what we're all about. So with that, I'm going to hand over to my colleague, Nigel, who will take the next presentation.

[Nigel]

So with that in mind, I'm going to show you how we have made our platform as intuitive as any type of technology that you might use in your personal life. For me, when I'm doing the demonstration of Teckro, I'm going to imagine that I'm a principal investigator or a sub-investigator working on one of your studies.

And the reality of how sites perform on a study by study basis is really they typically have only five or maybe six minutes with a patient. They may or may not have many other studies that they are also working on, in addition to the one that they might be doing for your company. And the whole thing behind Teckro is how do you make it easy for sites? How do you make it easy for them to communicate with the different stakeholders in the trial, and how easy do you make it for them to access information in that very short window of time that they might have with a patient.

So as a sub-investigator working on the study, if somebody says, doctor, there's a patient outside here for visit two on ABC Pharma's trial, or if they say there's a patient here with a potential toxicity. The Teckro approach is that you simply take your phone out of your pocket, and you'll see my personal phone on screen. I have all my usual apps, that I would use in my daily life. But at any stage, I can open my Teckro application. You can see here I'm brought into the Innovate-1 study. I can have as many studies as I want within this one application.

So in the top right, you might see "switch study" in orange, I can toggle between any of the other studies that I might have. So with Teckro, it's one application regardless of the number of studies the site is running. It is not a case of giving them an app for every trial, which I'm sure we'd all agree would become, very irritable if our phone was filled with clinical trial applications. When I open the Teckro application, the first thing I will see is a search box across the center.

And I suppose the way we think about it, in your daily life, if ever you have a question, you want to check a sports score, you want to check your bank balance, or you want to look up a phone number for a restaurant, most people will go to their search engine of choice. They'll type in a few letters, and they'll get an answer within a second. It's the same with Teckro.

You open the Teckro application, you're presented with a search box. You can type anything into that search box, and in less than a second, it will have checked all of the relevant documents such as the protocol and any amendments that are relevant. The investigator brochure, lab manuals, maybe you have pharmacy manuals in here too.

But the whole idea is you type something in, and within a second, you'll have the answer. If you think about how sites access information typically today, it's usually a case of somebody runs down to the coordinator's office to get the paper protocol, to look up the section of the protocol, and find their answer. This can take a bit of time, the co-ordinator's office might be quite a bit away from where I'm seeing a patient, it can be very inconvenient to go and have to get that paper document.

Or, alternatively, you might have to find the computer, log into a portal, open a PDF, maybe do a CTRL+F search for the term you're looking for. Again, time consuming, and doesn't fit in conveniently with a busy physician or a busy nurse who might have only a few minutes with that particular patient. With Teckro, however, it's different. You take your phone out of your pocket as I have just done. You open the Teckro application, you get a search box, and you start typing what you're looking for. And I'm going to show a couple of examples to show you how intuitive this is and how quick it is to access any piece of information.

So whether it's something like you want to check the inclusion criteria because maybe you're thinking of enrolling a patient. It's a very basic kind of example. A lot of us might remember the days where we gave out laminated cards to sites. But you can see after typing in three or four letters, it knows what I'm looking for. It brings up inclusion criteria. And in this demonstration example, as you can see, there are only eight, but you have the full list there at your fingertips. You'll also see that I'm able to rate sections of the protocol. So if I wanted to, I can give feedback on, you know, different sections of the protocol that I access, which is valuable then, because all this information is collected and made available to sponsors on an ongoing basis.

You'll also see I get related searches. Most people who look up inclusion will also need to look up exclusion, so I could do that very conveniently here too. A very basic example. I might show something a little bit more complex. Maybe I need to check the conmeds section of the protocol. I have a patient. They're on trial, maybe they've developed an infection, and I need to look at what antibiotics might be prohibited or allowed on this study. Now it's an intelligent search engine. I can type in concomitant medications. I could type in prohibited medications, or I could even type in conmeds.

The system will understand what I'm looking for. I could even type in a specific drug name, and it will check the inclusion/exclusion criteria for it, or it'll check the conmeds for me. But you can see within a second, I have the answer. And it's no different to someone typing in Super Bowl 1974, and it'll tell you who won, who got the touchdowns, where the game was played.

What we are doing here is mirroring how people behave in everyday life. And the real art to getting sites engaged and to providing value, is to give them something that saves them time and removes burden. So I, as a busy physician, don't have to run down to the office to find the correct paper protocol. I don't have to find the computer and try and remember my username and password for a portal to open a PDF document. Like I do in my personal life, I can take my phone out of my pocket. I can start typing, and this system will tell me the answer within a couple of seconds.

Every time it gives you an answer, you will see in the bottom left, it says view source. So when this system produces an answer, you can always check where that answer came from. And in this example on con meds, you can see it came from the protocol V3, and you can see I have the entire document at my disposal there if I wanted to go and delve in more. And maybe just one final example, very specific.

I want to check diarrhea toxicity management. I want to look at a specific grade of toxicity. I can type in "diarrhea grade 3 toxicity".

Compare that to having to get the protocol, find the appendix, which deals with toxicity management and working out what I should do for a toxicity that's graded as 3. So it's all about making it easy and reducing burden for sites.

There are two other elements I might quickly show, and one is around communication. In a lot of instances, PIs or sub-Is may not find the answer they are looking for in the protocol. And this can be a real frustration for sites that they have to send an email to the CRA or try and get the CRA on the phone in a very short time window with the patient.

CRA may or may not know the answer. They might have to escalate it. It might end up going to you and the sponsor team, and you have to, you know, cascade that answer back to the site, which can take days, or dare I say it, sometimes even weeks. With Teckro to remove the burden from sites, if I look up the protocol and there is no answer for my specific question, across the bottom of my screen, I can create this Connect channel where I can submit a query directly to the relevant people. So I can say whatever my question is; "Hi, am I allowed to rescreen patients?" Or whatever the case might be. I'm just using a very generic example here. And forgive any spelling mistakes, that I am doing. And that message is automatically delivered to the right people. We can configure this on a study by study level. Maybe it goes to the CRA. Maybe it goes to the study team. Maybe it goes to the CRA first, but can be escalated to the study team. All of those configurations are really up to you. But it means that from a busy site perspective, I don't have to think about where or how to communicate.

I simply take my phone out of my pocket, type in my message, click send, and you can see, somebody has responded to me already. So if you think of the first, that intelligent search engine, it's kinda reminding you a bit like Google, which we probably use all the time. This is like our favorite instant messaging platform, be that iMessage or Facebook Messenger or WhatsApp. It's all about making it easy and making it feel similar to how we behave in everyday life. So you can see my colleague has responded. I get the answer straight away, and I can even go on and rate the answer if I want to provide feedback.

During the course of a trial as well, we all know we send out updates to sites. Might be protocol study newsletter or details of an amendment that's coming, or maybe it's an enrollment update. For most people, that's sent out by email, just like we would have done twenty years ago. And despite all of the work that teams do in creating those communications, when you send it out by email, you have no idea who reads the message and who doesn't read the message.

And if you look at, survey and research results, the typical open rate is normally only around five or six percent. With Teckro, when a communication is sent out through the platform, it pops up on my phone as an investigator. I get the full archive of all the communications throughout the life of the study are here. It'll also go into my email inbox. Well, as my colleague will show later on, all the open rates, the details of who read the communications and who didn't is tracked and available to you as a sponsor so you can see who has been opening your messages.

And what we find is compared to the average email open rate, which is usually less than ten percent, Teckro is usually typically greater than fifty, sometimes going up to sixty, seventy percent depending on the type of communication and how targeted it is. But for a PI, you can see I have all my communications here. And within those updates that you might send out, you can embed links into the protocol.

So maybe if I show you some examples, here, if I go in, you can see I can quickly tap on read protocol synopsis here if need be. Or I can click communicate, and, of course I can rate communications as well.

So for busy site stuff, you know, there's no thinking required anymore. There's no burden required anymore getting into systems. You take your phone out of your pocket. You can search anything to do with the study in seconds and get an answer instantly. You can ask questions if you need further clarification or guidance.

It's all intuitive. It's all simple. And all updates about the study pop up on my phone, also go into my email inbox, and I can answer surveys or I can, you know, get links into sections of the protocol, all really intuitively. This platform is continuously evolving, so you can even embed training into Teckro now as well. So as a PI, I can go in. I can see what training I have to do. I could even go in and complete this training on my phone. So I could go in. I can open a video or PowerPoint presentation or a learning module.

And you can see when I've completed it, I digitally sign it through Teckro, and that record is kept and archived. And you as a sponsor can see which trainings are completed, which aren't at any stage. So the full record of certification is kept here as well. So that's just a brief snapshot of some of the core features of Teckro. It is all about making it easy for sites. When you make it easy for sites, you are more likely to get them engaged on the study. And as we mentioned earlier, greater than seventy percent of sites coming in every single month, not once and never to use it again, but coming in every month to use this platform because it's removing burden.

All the while, we are capturing data and sentiment about who's engaged on your study. And I'm going to hand over now to my colleague, Ger, who's going to take you through how this data can be used to truly influence site performance.

[Ger]

Perfect, Nigel. So Nigel showed you the mobile experience from the site's perspective. Now I'm gonna show you the web experience from a study team user's perspective, where the key difference here is the data and the oversight that we package up for study teams to be able to enable them and empower them to improve site performance.

So I have access to all of the same features that Nigel showed you. So I can search the protocol. I can access communications, but I'm really gonna focus on the data part. And what you'll see here when I land on the study, the INNOVATE-1 study, it's a demo study, you can see my home page has some metrics.

At the top, we've got three KPIs. The first is site engagement. Site engagement, as we've already said, we feel it's the most important metric in study conduct, and we're first to define it. And what we're doing here is tracking meaningful site engagement with your study, whether it's engagement with protocol, or other associated documents, whether it's sites asking questions or sites reading your communications.

We aggregate all of those signals up into this site engagement metric. Beside that, you see sentiment. So this is a brand new feature we're releasing just now. And this is an aggregation of three different touch points where we measure site sentiment in the experience. So when a site reads the protocol, reviews the inclusion criteria/exclusion criteria, looks at the visits, we offer them the opportunity to score sentiment, the same when they have received an answer to a question they've asked on the Connect channel or when they've received a communication.

And if you think of site engagement as the action or inaction that a site is taking, sentiment is more about perception. It's more about feeling. And our central thesis is that these are leading indicators. And if you optimize both of these, the number on the right will flow, which is recruitment, which you are well aware of. So we're now, with this release, integrating recruitment data into our platform, which allows us to build a quadrant, which Gary showed you at the start.

And what we're doing here is we're taking all of your sites and plotting them into one of four segments. The axis on the bottom, the horizontal axis, that reflects low versus high enrollment. In this case it is which sites are below expected recruitment rate versus at or above expected recruitment rate, and we're marrying that together with our metric of engagement. And that allows us to plot these four different segments.

And there's two key ideas behind the quadrant as Gary hit on earlier. Number one is, and we've looked at this countless times, must be a hundred different studies from a data perspective. We continuously see that sites that are engaged with studies on Teckro, they do better. They recruit more patients. They screen faster. So, really, what we're trying to do is capitalize on this relationship between engagement and study outcomes.

And the second big idea is segmentation. So not all of these sites have equal needs, and they need to be engaged in different ways. Gary spoke to the scenarios of engaging a low performer in a very different way than a high performer, and segmentation is the key concept that we're promoting here that allows you to really dig in and intervene with custom strategies for each of these segments with the ultimate goal of moving as many as possible to high performers.

So what I'll do now is I'll just move into the oversight section, which allows us to drill into this data in more detail. So I'm now in Teckro oversight, again within the same study, and I now have access to a lot more dashboards. What you see on the right hand side is the hierarchy of data. At the top is the Performance quadrant. We're introducing new dashboards that allow you to monitor site behavior and improve site behavior.

And then at the the lowest level, we have signals of engagement within your protocol in terms of the metrics and associated data related to questions sites are asking, are they engaging with your communications that you send, and the answers that they're getting back in terms of the service that you send out.

So you see here now, I'm on the Quadrant dashboard, and, really, this is about transforming engagement into improved study outcomes. I've a lot of, filtering capabilities here, and at the bottom, I'm really able to drill into the data. So you can see the data broken down by region or blending together lots of different data sources, so I can see how long a site has been open, their recruitment performance, but also their engagement performance. And the marriage of these different data sources allows us to take this very segmented view of our sites that allows us to make custom interventions.

On the right hand side, you'll see this option to customize the quadrant, and you see here you have lots of flexibility in terms of how you define high and low recruitment. So for example, if you're running a study that has a high screen failure rate, it may be more effective to look at recent screening. So all of that's configurable and adjustable here in Teckro, which gives you a lot of different ways to play with the data. So that's the Site Performance Quadrant. You can then move down into the behavior dashboards. So this is a custom dashboard we've built to measure and improve site engagement.

You have the ability here to filter by country, various time periods. We segment your sites based on their level or threshold of engagement. You can see engagements here trending month on month. As Nigel and Gary have said, best practice is seventy percent plus site engagement in a given month. And you're able to understand what are the different types of activities that those sites are performing each month. And one of the key activity groups we look for is this section in green. So this says where the sites are both accessing study documents, so the protocol, AND either opening your communications or asking questions.

And we love to see this high share of green here. You'll see it's what, probably ninety percent of the total engagement activity in this given month? That really is an indicator of best practice because not only are your sites reading your communications, or your study is top of mind - they're also engaging with your protocol and asking questions. And so on, you can drill all the way down into individual countries or down to individual sites.

So site engagement is all about patterns and identifying opportunities to improve overall engagement on your study. Sentiment, as I said, it's a brand new feature. Throughout the experience as Nigel showed you, we ask sites, in NPS style widgets, to score their experience - in the protocol, when they receive an answer, when they receive a communication.

And what we're doing here is aggregating that metric into an overall score, but also giving you the ability to split it out to understand which element of the experience is causing the most friction, and you can drill down by country or site to understand, is there a specific variance.

So here is, for example, a country where you can see there's specific issues, and that needs to be investigated and dug into. And signals at the bottom, right. So these are the lower levels of activity where you can really jump in and deep dive into what's happening in your protocol as the first option. So you can see total search activity, of that, what proportion is protocol activity. You can see trending over time. But more importantly, you can really dig into what type of engagement you're seeing within your protocol, what sections are your sites reading and accessing, and are they doing so on a regular basis. So here you see a breakdown of which sections sites have accessed, breakdown of SOA usage, trending keywords, these are search terms that have been entered into the search box that Nigel showed you, all the way down to understanding regional trends so you can assess what level of engagement with your protocol you're seeing in specific countries or all the way down to individual sites.

Nigel just showed you the Connect experience. Really that's all about delivering an amazing, best in class customer experience for your sites. We hear time and time again that a pain point is that sites aren't getting answers to their questions fast enough. With Connect, we're seeing a step change in that mantra. Here, you have full oversight of that experience, so you can see how many questions your sites have asked, and how long it's taking them to get a response.

You can see what proportion of questions are open or have been resolved, and you can even drill down to read the actual questions that have been asked, which for a lot of studies is a source of insight, which can inform clarifications that need to be sent out to other sites. And so on and so forth, you can drill down and view message performance in terms of communications that have been sent out. You can analyze results of surveys that have come back that you've sent out. All of that's available here on Tekro. We take all of those critical signals of site engagement.

We aggregate them up into higher levels of site behavior. And if you focus on driving the right type of behavior, then improvements in performance will follow. Before I finish up, I'm quickly going to show you one new capability that we've added into the platform. Nigel showed you he was able to, with a messaging-like experience, able to ask a question where the PI couldn't find the answer in the protocol. He reached out. He got an answer related to screening back really quickly.

One of the key new features we're introducing with this release is FAQ Copilot. So, again, I'm logged in here as a study team user. You can see the question that Nigel has asked, so I'm unsure about screening timelines. And what you can see here are suggested FAQs that we're trying to match to the question.

So we're using generative AI here. FAQs have been preloaded into the study. And whenever a question is asked, we're now connecting the FAQs with the question and the source at which the question was asked. And our goal here is to reduce burden for CRAs, to enable this really fast response, back to site staff, and ultimately, to allow study teams to retire the FAQ spreadsheet. All FAQs can be managed here directly in Teckro.

We have a matching algorithm here that appears in the conversation, but you can equally browse through available FAQs here on the right hand side. Dependant on the configuration that you want to set up you can you can allow specific individuals to add an FAQ directly from the conversation. That can be limited to certain roles like monitors or study teams, it may not necessarily be needed for FAQs. But, really, this is about how do we, you know, use the latest technology to really reduce burden for site staff and for study teams and CRAs. So that's it from my side. We're gonna hand back over to Gary who will close this out.

[Gary]

Great, thank you, Ger. And just to bring this full circle, if you like, and bring this webinar to a conclusion. I just want to maybe come back to where I started.

Most study teams operate models today where we spend a lot of time thinking about site selection, protocol design, trying to set everything up correctly at the start of the trial. And then almost like a waterfall model, we have to wait and see what finally comes in, in the actual data for the trial. That creates a big blind spot for study teams. And so you're relying on these lagging indicators in the actual data itself, or at best anecdotal or qualitative data to kind of point to problems or issues you might have. All of this, what we hear consistently from leadership across all the customers we work with, it tends to lead to hesitation on the part of study teams to make decision. They wait longer hoping things will get better. With Teckro, the shift is really towards leading indicators.

As Nigel kinda took you through in the site experience, it's it's really trying to engage sites in a meaningful way, a consistent way throughout the course of the trial, capturing that engagement and mapping that engagement to trial outcomes. And we can look at maybe the world without Teckro today and, you know, we can put PDFs in portals or folders in the cloud. We can send people to visit sites. We can send out emails and communications, we get very little data back from that.

You might get an access log. You might, if you're lucky, get an open rate. You might get a spreadsheet telling you all the sites that were visited in a particular month, and maybe some narrative about it. But the key for us is, after that action has happened, how does it impact trial performance? How does that impact trial outcomes? With Teckro, every action through the platform is now a valuable data point. Those data points collectively manifest to come into that Quadrant view where you can see the impact on engagement on trial performance and trial outcomes. And that is the key approach that we're talking about. It's going from, you know, essentially a days on-site model with some bolt on technology to really a data-driven approach to site engagement and site performance management. Digital first, data-driven, then you can augment it with days on-site and other expensive activities. But you're getting a window into site performance you've never had before. You're getting really informative quantitative data to enable better and faster decision making. And really, as I said at the start, and I'll repeat it again, it's all about how we take an approach of targeted interventions, to drive more sites, to engage more sites, and to get more sites to become high performers. That's really how you meet your recruitment timelines, or your study goals and study objectives.

So with that, we might just take a few questions. I want to thank everybody for staying so long with us on the webinar, and it's great to see the participation. But just one or two quick questions that I might ask my colleagues to help answer here.

Ger, we've got a question, what's the typical response time that you see from site staff, when they ask a question via the Connect channel?

[Ger]

Typically sixteen minutes is what we saw, in the last quarter, and that's an average response time across a number of different studies.

[Gary]

Okay. And can messages be exported to the Trial Master File, or is that a manual process, or how best can sites do that?

[Ger]

So site staff can access any message that they've received, or any response that they've received and generate a PDF for filing in the ISF. The equivalent experience on the study team side, all messages can be easily downloaded and exported for the TMF.

[Gary]

Great. Maybe, just one last question, before we wrap up. Just the FAQ feature, if the CRA doesn't see a suggested FAQ, can one be created or can the study team create a question, can that be done?

[Ger]

Yeah. So I gave a quick overview of the FAQ Copilot experience. If the CRA doesn't see an FAQ that's available, they have the ability to forward that conversation. Almost think of it like first line defense/second line defense, onto the study team or medical monitors, and then we could set it up in a way where the medical monitor can actually then generate a new FAQ, which closes the circle. So the next time that question comes back in, that FAQ is now visible to the CRA.

[Gary]

Great. Okay. I think we're coming up close to fifty minutes, which is longer than we thought we'd be online for. So I want to thank you all again for for joining. Hopefully, you found it useful.

Feel free to to reach out, to Teckro, via our website or other channels. We'll be happy to engage further with all of you, and any questions you might have. Thanks again everybody for participating, and look forward to seeing you again sometime in the future.