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Clinical trial technology as forward-thinking as your clinical trial

Tufts CSDD Deputy Director Ken Getz presents research on investigative site staff accessing and referring to protocol information.

Webinar: Investigative Site Experience Accessing and Referring to Protocol Information

Thank you. And what I'd like to do is really touch on where sponsors can really improve access for investigative sites, perhaps more the sites that are already operating. So as you think about once you expand the pool of investigative sites, how do we keep them in our studies? Many sponsors look at this as essentially an effort to do cross, to become the partner of choice for investigative sites, to ensure their success, to think about accessibility in terms of operating support for investigative sites so that they can meet some of the challenges of conducting clinical trials.

The tough center for the last 20 plus years, has been characterizing protocol design trends. And obviously the design of the protocol itself has a huge downstream impact on the feasibility of the trial and the ability of the investigative site to execute successfully. And this is one area where we often see that sponsors are not nearly as aware as they need to be about the impact of complexity on performance. If you look just at the design of our protocols and here we're only looking at the most recent 10 year period and we're looking specifically at protocols or pivotal trials or phase III studies.

And you see dramatic increases in the number of endpoints, almost a doubling with a much larger number of tertiary and secondary and more miscellaneous endpoints, a 60% increase in the number of inclusion and exclusion criteria, similar growth in the number of distinct procedures that have to be conducted in order to support the endpoints. And an area where we've seen more modest growth, 25% growth over a 10 year time horizon is in the number of planned volunteer visits. That slower growth really indicates that a larger number of procedures are being performed at every single patient visit.

On the right hand side of this slide, you see the growth in data volume. And this is just a really important area for us to think of because it another way of characterizing the burden of supporting a protocol. We've seen nearly a 200% increase in the number of data points that support a pivotal trial. We're now approaching an excess of 2 million data points for a single protocol, and that growth is coming largely from the non-core area data that is supporting those tertiary and exploratory miscellaneous endpoints.

One other point to make here is that a lot of the data we collect, we're pushing out even past the clinician out to the patient themselves. So patients are being brought in to play an even larger role in providing and collecting their own data. One other data point we've tripled the number of data sources to support or to contribute to the study database. So today, on average, a clinical trial involves six unique data sources, including wearable devices, smartphones, etc.,

where the investigative side often has to act as the technical support for many of these newer data sources. It doesn't take much to recognize that as complexity has increased, the burden on the investigative site has increased as well. And as we move to more remote and virtual models, that burden will continue where the site has to play an even larger role. We've seen very, very high growth in the work effort, which includes not only the number of procedures that the site has to implement, but the time that they have to commit to them as well.

And this, of course, has an impact on recruitment and retention performance, among other performance measures. When we look across all therapeutic areas, we typically have to double the planned enrollment timeline today in order to achieve the target enrollment rate and the cycle time. When you look at complex protocols to those that are simpler is nearly double the length, 73% longer. On average, complexity is also associated with the incidence of protocol amendments.

The number one reason we amend our phase two through four protocols is to relax the eligibility criteria because it's been so difficult to find patients based on our initial inclusion and exclusion criteria. And the typical amendment, as many of you know, is unplanned. It's unbudgeted. It adds about three months of time and costs about a half a million in direct costs to implement.

So I want to tell you about two studies that the center has been involved with this year. The first is a study that is currently underway. It's a working group study. With sponsors and crows, where we're continuing to update our protocol, design, benchmark data and look for predictors of performance.

And that's a study that we anticipate will be completed in December of this year. And we also just recently completed a study in collaboration with tech grove, where we went out to investigative sites to really understand how they are referencing, how they're using the protocol guide them and to provide reference for their instructions in terms of executing the protocol. And it includes responses from 228 investigative site personnel. This first slide looks at how often sites are accepting different sections of the protocol.

And as you'll note right away, so many of the sections are accessed very, very frequently. In fact, well over 90% are reporting accessing the majority of these sections in the protocol to find useful information that will guide execution, the schedule of assessments, eligibility criteria, scripts, screening procedures, et cetera the two areas where we are three areas, rather, where we see much lower frequency of access include adverse event reporting, data reporting requirements and the management of toxicity. These are also the primary areas where we see much lower levels of helpfulness, perceived helpfulness from the site, and which suggests an improvement opportunity.

We suspect that these areas are given these lower ratings and their access less frequently because they typically involve multiple parties internal to the sponsor and external eye as to provide guidance. The sponsor is own peers. Regulatory authorities as well as safety representatives are all providing guidelines that sites have to try to navigate and reconcile. And so these may be areas where you see work contradictory instruction and you may see more confusion.

Here we're looking at how sites typically access information in the protocol, and we're also looking at the amount of time that it typically takes. And one point that really jumps off the page immediately and one that we consistently see with most sites is that the approaches that are used are generally less sophisticated, the use of a desktop computer or a paper copy or reference card. We also see a very, very high percentage that tell us that they very or somewhat often go to the study monitor directly for that information. And the two areas where we see the lowest level of frequency and access is the tablet version and the smartphone version, areas that we anticipate will increase under more of a remote environment.

I want to also point out that although the study monitor receives a very high percentage, 80% of sites who indicate that they very or somewhat often contact the monitor for information, it's also the most time consuming where almost 60% tell us that this interaction typically exceeds 20 minutes of time. The last area I just want to touch on again to frame our thinking about how to be a sponsor of choice or a partner of choice is the protocol of Amendment area. You'll recall, I mentioned a moment ago that a protocol amendments increase with more complex protocol designs. And in this particular study, we also learned that the most common way that protocol amendments are communicated to sites is perhaps one of the less sophisticated approaches, the use of e-mail, and that in fact, the use of a sponsor or 0 portal received a very, very small percentage, less than 15% So we view this as another area where you would expect to see increased use of more sophisticated communication technology.

One last point I just want to make here is that despite the use of less sophisticated methods, the vast majority of sites report that they're competent, that they're using the most up to date version of the protocol. So that's good news for us. But again, we're looking at increasing sophistication as we move and migrate to more hybrid or decentralized clinical trials.

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Intelligent search

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Want to achieve best-in-class results?

Don't miss this opportunity to hear from those successfully earning
trust and retaining the coveted “top of mind” position with their study
sites! Our panel shares tips to achieve best-in-class site engagement
using communication best practices.

This webinar draws on successful examples from leading pharma companies
using Teckro to foster enduring site relationships. Our experts
illustrate what’s possible with targeted, timely communication
campaigns.

In this webinar, you will learn:

<ul>
 <li>The benefits of effectively identifying and segmenting audiences for
tailored outreach and the impact on sites opening study messages,
including the exponential power of localizing communications.</li>
 <li>How modern tools such as Teckro drive recurring engagement with study
resources, and why the timing of your communications needs as much
consideration as the content.</li>
 <li>The impact of regular, consistent outreach and why, when it comes to
measuring and optimizing your efforts, you shouldn’t accept anything
slower than real-time data.</li>
</ul>

Your Follow Up Questions Answered

Communication Best Practices for Enhanced Site Engagement - Your Questions Answered

We've had some really interesting questions coming in today on the webinar. We're going to actually take some time now to go through those additional questions and answers as we do not have time to complete them during the during the webinar session.

Perfect. So, I'll get us going with questions, Brian, first question and this is we've combined two questions here. So: You've shared some interesting examples of successful engagement in the recruitment phase. But is this also applicable to sites and studies as they move into maintenance or follow up stages on a trial? And then related: Any communication best practises for later stages in the trial? So, for example database lock and after site closure?

Yeah, I think these are excellent questions. Certainly, some of the example use cases we have in the Communication Workshop content and also in the playbook do reference I suppose around the recruit area. But the same principles can be applied at any stage of the trial if we take for example a study that's moving into post recruitment or that maintenance phase, there's important communication that needs to be shared with sites. 

And again, you want that oversight, you want to know if they've read it. We have teams using that across the different therapy areas. Back to the question around database lock - It is very a key there I suppose.

We're working with the team a number of teams at the moment where I'm working with them, and they have like a countdown clock ahead of database lock. So, one month out, two weeks out from database Lock - initially sending a reminder alert to the sites around that important date at a local level, and then in addition to that using survey in some cases, to find if there are challenges around meeting those database lock, and what they are. So again, the use cases and the examples are very applicable in those stages.

Perfect, very clear. Thanks, Brian.

How do you obtain the site open rate data and how about those communications that are pushed to a site sponsor report? So, I'll maybe have a shot at answering this one. So, site open rate is a metric that's unique to Teckro. 

When communications are sent on our platform, site staff receive an e-mail notification or a push notification with a snippet of the communication. But that communication must be opened in the Teckro app.

So assume the communication is sent out, you receive it, you get the push notification, you tap, and you read the communication in the Teckro app. And based on those type of activities, we're able to then measure how many sites received the communication versus how many sites opened the communication and that creates the site open rate metric.

Our understanding is that sponsor portals don't provide this type of metric. Nor is it possible to measure open rate on emails that you would send through outlook, for example. We feel it's a critical metric because without this it's really hard to get a sense of how good or bad your communications are, and which sites are engaging with your communications or not. So, if you can't measure, then you can't improve, essentially.

We did have some data in the presentation related to e-mail open rates. Now these are industry metrics. We get these from reputable third parties that specialize in in e-mail delivery, so only they can measure it. It's not something that you could for example, can get out of outlook when you send out an e-mail to your sites. 

So, I hope that helps.

Perfect. So, the next question then is: For the survey, did you provide the answer selections?

Yeah, I can take that. So, with Survey, when the study teams, either global or local, are sending out a survey through Teckro direct to the team or to the sites - in the creation of the survey, they'll create the questions. 

There will be the option to add those action buttons where you can have the answers available. Most teams would, I suppose, work with us to create templates at certain stage of the study. So then, the template for the survey is already created with the answers. When the site receives it, the site will see the answers available. Some teams do add in an “Other” or “additional comment” answer if they need to gather extra information that can't be gathered by a simple ‘1of 4’ answers.

Perfect.

In the presentation, we had some visuals that were linking out to different places and one of the questions was: Where are you linking to? Where are you housing your links? Do you have a shared space?

So the visual is related to the Teckro experience and in the Teckro experience, one of the things that's key is that our content and communication are completely interconnected. 

Everything is designed to keep sites active in the app, which in turn leads to engagement in the study.

Specifically in the presentation, we had some examples where the communications were linking to inclusion/exclusion criteria. 

So, what's actually happening there is that when you send the communication on our platform, you can pick where within the protocol you would like to link to. So, it's very much an integrated experience and when site staff receive that communication and click that link.

They'll be taken directly into the section of the Protocol, whether it's inclusion criteria, scheduled activities. And all of that is based on the version that the site should be assigned to as well, right? So, it's very much a version control solution.

Study teams can also link to third party websites or systems. So, for example EDC/IRT system or even a webinar. 

Or you can also have an additional option to, allow the recipient to ask a question using our platform so sites have a dedicated channel to reach out if they need support.

Next question for you, Brian. So: Some sites are harder to engage than others or have extra challenges, for example - research naive, how do you ensure awareness and engagement with these sites?

Yeah, I think that's a very valid question. So, for a lot of the teams, if they're working at a global level, it's ensuring, I suppose we can recommend Teckro best practise for the engagement of your sites and particularly for the engagement and awareness of those sites - of Teckro. The good news is for a lot of the sites, they may be utilizing Teckro on one or more studies. So, for them it's just an extra study appearing in their study list and it's very simple. But for newer sites, if we take research naïve, other sites - it's ensuring there's awareness of Teckro. And this is really key, I suppose, in the communications that are sent from the study team – from global to local and then from local to site, where for example, we are very familiar with joining meetings such as investigator meetings, whether virtually or in person, supporting awareness of the SIV, and also then supporting their local trainings.

Just to answer the second part of the question. When they were talking about “is it harder to engage sites?” - certainly there's a lot of turnover in the industry at the moment. CRAs in particular and also site staff. The continued awareness is important. Just like with any technology you want to make sure sites are aware of the key benefits so they can see the benefit of getting those updates in a quick and easy way. Also, the ability for them to have somewhere to reach out through the channels, it's highlighting those benefits to those sites, particularly maybe in the maintenance phase as teams are turning over.

Perfect. Thanks Brian. OK. So: How many languages are in the Teckro app?

Yeah. So, I can take that. So, at the moment, Teckro is utilized in all countries across the globe or in the majority of countries you’d see in a global country list. The communication functionality that we talked through, so if we call that Alerts - that supports the majority of languages that people are communicating with through technology. 

So, it's greater than 30 plus languages are supported there. This allows the teams from a global team to communicate with their sites in that chosen language if they so wish. And I suppose a lot of teams might use English, but then you do have the flexibility in that for people to use Spanish, Italian, French - if they're in those specific countries and that's for the Alerts and the communication. 

For the Content piece. So that's your study documents, you can access and search those on Teckro, we can host the documents in any language, and those documents will be visible. For the Search features they can be enabled for English, Japanese and Chinese documents. 

And that's where we've seen the need, particularly in Japanese and Chinese sites. The ability for them to access Teckro, search in their keyboard, in their own characters, and retrieve the answers from those local documents has proved very successful in securing site engagement on those studies. 

Perfect. There's a question here, Brian, that builds on the answer you've just provided. So: Do you see any regional variation of trends in site engagement?

So, from a data perspective, for the most part, we don't see significant regional differences in site engagement. We've over 70 different countries, site countries, across the world on the platform. The factor that, Brian touched on this, the factor that typically influences site engagement, is the communication approach.

And we see that studies that have you know geographies across the world that follow a consistent engagement approach do see healthy consistent engagement across those regions. 

So, one of the recommendations I guess is, if you are struggling with site engagement in a specific region, is to consider localization and to translate. The content of your communications for those markets. Typically, on Teckro we do see higher open rates and site engagement on communications that are localized, so it’s definitely worth discussing with your local teams, right? And trying to understand if that’s an important, should that be an important part of your site engagement approach overall.

So the last question, Brian, and I'll leave this one to you: How does site engagement and best practises vary across different phases of trial? So, for example, phase one versus phase three?

Yeah, that's a very important question. And I suppose it kind of links back to the earlier question when someone asks about the different stages of the trial, does site engagement vary or what's the best practices there. The answer is yes. So, site engagement best practices will vary in how you apply Teckro best practice to get enhanced site engagement. 

If we take phase one trials - items that are happening there that won't be happening in phase two or three - maybe cohort management and maybe there's dose escalation. So, we have teams who are using Teckro to alert their sites around cohorts opening and closing - so that effective, timely communication. 

In some cases that might be slot allocation, which requires even faster communication. 

They're utilizing outbound communications through Teckro alerts to alert the sites of an open slot, and then the site has the ability to access a channel to alert the team that they have a patient suitable for that slot and then the global team can alert all sites again, to say that that slot is now closed or been filled. So there are ways in which you can utilize Teckro for each of those trials. That’s an example for phase one, phase two and three we covered in some of the slides that we utilized already, and certainly in phase four, it's just ensuring effective communication direct to your sites.

Brilliant. Thanks very much, Brian. I think that's all the questions covered.

Yeah, I think so. Look, thank you for everyone who submitted their questions during the webinar and also for these additional follow up questions that we’ve cover now. Now if there are additional questions that come to mind, certainly as we mentioned, you can reach out to me and any members of the program team to schedule a one-to-one workshop where we can look at your trial, your team's questions and apply Teckro best practise to ensure enhanced engagement. So thanks, Ger. Thanks everyone. Enjoy your day.

Thanks everyone. Thank you.

Centralized resources

Enabling Sites for Outcomes - Fundamental Principles for Today’s Clinical Trials - Lydia Beaudette

Webinar: Enabling Sites for Outcomes - Fundamental Principles for Today’s Clinical Trials - Lydia Beaudette

This media does not have a transcript.

Digital SOA

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This on-demand webinar draws on successful examples from leading pharma companies using Teckro to foster enduring site relationships. Our experts illustrate what’s possible with targeted, timely communication campaigns.

Communication Best Practices for Enhanced Site Engagement

Enhanced engagement

Embedded Call to Actions

Targeted communications

Built-in surveys

Protocol query channel

Seamless query triage

FAQ Copilot

Sentiment capture

Multi-media

Exports for TMF

Mobile-first training

Onboarding guides

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Self-service study management

Document version management

Localization

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Digital experience

Our latest webinar explores a fresh approach to measuring and managing performance - particularly with low or non-recruiting sites. Our speakers demonstrate how leading indicators of site engagement unlock value from your recruitment metrics, feeding targeted interventions that reduce time to LPI and optimize spend.

Data-Led Trial Management

Site Performance Quadrant

Closing the Gap in Clinical Trial Communication

Join us as we look at a new approach for investigators and site staff to connect with both study content and experts, so they can get the guidance they need, when and where they need it.

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Clinical trial success is dependent on effective communication between study teams.

Hello and welcome. And today, we're going to look at the topic of communication that we know that clinical trial success is dependent on effective communication between study teams and research personnel. And yet when we talk to sponsors, they aren't really sure the best way to communicate with sites that is helpful for them. And on the other side, we know that research staff are often frustrated at how long it takes to get answers from study experts.

So in today's session, we're going to look at a simple, modern way to connect investigators inside staff with both the study instruction in the protocol, as well as expert guidance when and where they need it. And we'll also look at how study teams gain critical insight into both trial performance as well as engagement. Now for today's session, I'm joined with a couple of tech experts. First, we have Andrea Parrish, who is tech co-head operational excellence.

Andrea has been in the industry for quite a long time, so she's very well-suited to talk through the challenges and also to present a solution for us in terms of bridging the gap of communication. And second, we have Declan O'Dwyer, who is a tech product manager. And if I'm not mistaken, he's one of the very first employees at tech grocery. He's been here for quite a while.

He'll talk about some research that we did for the launch of a newer product within the communication side of the tech portfolio. And he'll also take us through a scenario to show the potential of how this product can work to bridge that gap myself. I'm Kelly brown, and I am the chief marketing officer for tech growth, and I'll be moderating this session. For today's agenda.

We have a few simple things we'd like to accomplish. So, first of all, I will go through today's challenges with communication. Next, we'll look at a new approach to New way of thinking about how sites and study teams can be communicating. And then we'll look at a sample scenario flow of what is possible.

And finally, I hope we will have piqued your interest enough that you want to find additional information. And so I'll point you to some additional resources at the end of this presentation. Andrea, over to you. All right.

Thank you, Kelly, for the introduction and for the opportunity to speak with everyone today. Well, let's just get started. When we think about the challenges involved in conducting clinical trials, I think we can all agree that there could be a number of contributing factors. We know that sponsors and sites are focused on the overall safety of the patient and that the trial is conducted in accordance with the protocol.

And in order to manage these responsibilities, it requires efficient and effective communication with the key study stakeholders. So taking the challenges we just spoke about into consideration and knowing how important it is for sponsors and sites to meet their objectives, the lack of effective communication is a key component to contributing to some of those challenges. In addition, inefficient communication has a direct impact two variables that are absolutely critical for the sponsors and sites during the conduct of clinical trials, and these include time cost, quality and compliance and visibility.

So we know that the inefficiencies in communication exist across a number of stakeholders. But I wanted to focus this discussion today on two distinct groups, specifically sponsors and sites. So why focus on just these two groups specifically? Because ultimately, sponsors are required to maintain oversight of all trial conduct related to their protocol or study, and sites are required to ensure the safety of the trial subjects and remain in line with the requirements of the protocol.

So the inability of these two stakeholders in managing this these requirements has the potential to put the trial and the trial subjects at risk. So this would be an issue. So communication is key. So what are some of the challenges experienced by both sponsors and sites?

Here's a few that just stand out that came to mind specifically for sponsors. I would say that there are multiple stakeholders and oftentimes it is very hard to align on key decisions. Also, delayed response times from sites and series is very common for sponsors. Finally, there is no visibility in any site activity.

You don't know what documents they're referring or referencing as an example. You have no idea what's happening out there at the site. So what are some of the site's challenges? Well, it's difficult to get protocol clarifications resolved quickly.

We know that there are important study details that are actually buried in email that are never actually accessed. And for those of you out there that work with multiple sponsors, you do know that you're working across multiple portals for those different settings. So you can imagine how difficult it is to try to manage in between all of those passwords. So also finally, four sites, I would say managing multi-site trials and streamlining that communication.

What we've been told can be very, very difficult. So as I mentioned previously, we need to address not only the impact of inefficient communication on sponsors and sites, but we also address how that inefficient communication has a direct impact to time, cost, quality and visibility when conducting the clinical trials. So let's talk about what can improve clinical trials, and I want to talk about how to approach can help address some of those variables that we've been referencing. So just to get you oriented, we just to let you know that tempo has three pillars which can help sponsors and sites improve the clinical trial process.

So what are those? These are insights, content management and communication on the whole. But, you know, having mentioned how important communication is to sponsors and sites, we're going to focus on this key area for discussion and specifically how it relates to those attributes. We spoke about time, cost, quality and visibility.

So let me elaborate on a few examples on how tech broken can have a positive impact on these variables. So let's start with time. Well, we all know that time is of the essence. With sponsors and sites, it means everything.

So with tech row, what you can expect are faster answers to your protocol questions because you can get those answers right in your palm of your hand. Quicker decisions and in terming eligibility of patients. Our study participants, I mean, this is critical when they're sitting in your office and you have limited time with the patient and the protocol, and you're going to have faster clients or access to critical site information, which often is not happening. It's sitting in binders on a shelf.

Right so next, let's address cost. We know that money matters and the cost of doing business is quite extensive in the clinical research space. So sites and sponsors are always looking for ways to be cost efficient. So with tetra, what can you expect?

You can expect fewer protocol, deviations and quality issues. Having that seamless communication channel reduces the probability of those instances occurring because you're getting the right answer the first time. You're also you can also expect faster recruitment by connecting with the sites and keeping them engaged all throughout the study, which is rare. So now let's talk about quality.

We all know that the goal in the clinical trials space related to quality is compliance with the protocol. So what can you expect to grow in this space? It would be proactive compliance. You're actually de-risking the trial in real time because of the features of our platform.

You're able to understand what those risks are and manage it with the tools that we have, particularly our communication channels. You also have direct access to medical experts with our product. And finally, in this space, I would say that have a targeted communication channel, and we all know these. We would much prefer a targeted message in your hand versus waiting through spam.

Those emails never get read and therefore you are getting information that is irrelevant for you. So finally, let's discuss visibility. Right now, we know that there is zero visibility into how teams are accessing information about the protocol or starting study documents. You have no idea what they're touching or reading.

So but what you can expect with tech row, though, is access to who is interacting with the study documents and when. Also, you have the ability to see who is opening and reading study messages. So you can begin to gauge who is engaged with your study, which is critical for all clinical research trials. And then finally, you have immediate feedback to assess, study, feasibility or sentiment regarding the study.

Again, all of these are ways in which you can improve the clinical trial process in the communication space. All right. So as you can see, the tech platform can have a direct impact to the communication challenges faced by both sponsors and sites. The communication streams we just spoke about are seamless, directed and instant and can help you manage the variables that are absolutely critical for success during the conduct of clinical trials.

Specifically, as it relates and coming back to it again, time cost, quality and visibility. So back to you, Kelly. Thanks for taking us through that, Andrea. And I would like to pause for a moment here to just set the context a little bit more around the tech product portfolio.

So as you can see from this chart here, Andrew has taken us through the three pillars around insight, content and communication around that. We have several different products that you can see. So we have tech search, which is related to the content side. On the communication side, we have tech connect, tech engage and we have tech survey and they'll serve different purposes.

But for the point of today, what we'd like to do is talk a bit more about tech connect, which is one of the newer products within the portfolio. And for that, we'll have Declan take us through from product manager perspective the explanation of how and why we came to ad tech or connect to the product portfolio. And then he'll take us through a sample of how it can actually be used. Thank you, Kelly.

So I'd like to start by giving some insight into the evolution and background of tech connect, which essentially can be described as a communication channel, which allows sites to speak directly with medical and study experts. The common recurring theme that we found when speaking with sites was that they frequently become blocked, and it's a direct result of poor and inefficient channels of communication. And we found that this lack of direct engagement with the experts are a source of truth, if you like, and can lead to a lack of trust in the integrity of the information that they're receiving.

And it also leads to unnecessary delays. And sites are often delayed for disruptive really long periods of time. And when waiting for term vacations. So by introducing this direct channel with the experts and removing the potential need for clarification to have to come through a third party.

And tech reconnects and not only improves the time resolution for sites, but also improves the level of trust in the integrity of the information that's being returned. And then with sites unblocked and they can move forward with their day to day activities unhindered. And this ultimately leads to improved site engagement and productivity. So I would like node to walk you through a sample user flow of how Tech Connect could be used in a clinical setting and support.

Noting that in this scenario, key to the trial success is that the study experts can respond to questions in a very quick, a very short time frame. So in this scenario, we have a principal investigator, Dr. Michaels, who needs clarification and how to proceed with treatment for a patient who has experienced skin reaction and is first port of call is to search for the relevant protocol instructions on his mobile phone using type of search. Having done this, he then finds that he needs for furniture, for patient, determine whether the patient needs a dose reduction or where the treatment needs to be interrupted.

In order to do this, he simply types this question into tech, reconnect and starts a conversation with the team of experts on a supporting site. Then we have a group of medical monitors who form a team of supporting experts. And they are fully prepared to respond to messages when received. Having been trained on tech or connects, they are ready to react when alerted and as tech reconnect supports rapid alerting.

All of the team will be notified when a message is received, whether that's within the application or by email or push notification on their mobile phone if you happen to be offline at that point in time. So in this instance, one of the team responds to doctor Michael's, informing him that, yes, the treatment should be interrupted and doctor might extend. Having read and having read the message, the physician needs further clarification around how best to proceed with treating the patient's skin reaction itself. And he simply asks an additional question.

In this instance, a different member of Team responds and terrifies how best to proceed with the treatment. Once start to meet, the standards confirm that he's happy with the information that he's received and is clear, fully clear as how to proceed. And any member of the team can then resolve the conversation at this. The conversation can be exported to PDF for inclusion with trimester form.

So in essence, here we have an example of a research team answering the question, making the right decision in a timely manner, and maintaining the patient safety and doing so all in compliance with the protocol. The scenario that Declan just walked through with us is not just theory. We recently had a phase Ii study where a research team needed time sensitive guidance related to the participants safety, which is always paramount in less than 15 minutes. The principal investigator had everything that they needed, and it started when the study coordinator using tech research to find a protocol instruction.

But the pi needed further clarification. So what happened next was they used the tech reconnect feature and they initiated a conversation with a medical monitor who responded to the question within 4 minutes, which is unheard of, as we all in this industry. So after a few more clarifications, the research team was very clear on exactly how to proceed. So all this, as you can imagine, in just minutes.

So imagine in the old model how long this exchange would have taken. We all know there is no comparison. So that concludes my summary today, and so I'll kick it back to you. Kelly Andrea, Declan, Thank you both very much for your presentation.

So if I could summarize briefly what we saw today. We talked about communication and really bridging the gap between two main groups, sites and sponsors. And we also talked about four key components that are absolutely critical when we think about clinical trial operations being time cost, quality and visibility. And of course, sites have a role to play in that and sponsors have a role to play in that ultimately for the betterment of patient safety.

And we also talked about tech row and the fact that our platform is organized in three key pillars. But today we really drilled into the communication side. And as we saw with Declan, it really allows for a new approach for research staff to directly connect with monitors, study experts, however you want to structure your trial, but really allow for that direct, real time communication. So no more back and forth with email and no more time delays.

It really puts the answers at the fingertips of research staff, which again, is going to help with the four components we talked about and ultimately improve the trial quality as well as patient safety. And so from here, I'd like to wrap up, but I'd like to do is share some additional resources for people. As I said the beginning, hopefully we peaked your interest and you'd like to know more. So the first place is to visit terracom, which is our website, where you'll find more product information.

But we also have quite an active blog. So Andrea, for example, is a regular contributor and she's written quite a lot actually on the topics of quality management site engagement and others. So you might want to look at the blog in addition to some of the other resources that we have on the website. Second, if you'd like to have a demo, you can email us at demo tech Broadcom, and we'll have one of our subject matter experts set up a demo specifically for your particular needs.

And finally, if you are on social media, we are on social media. And we love to connect with you. We're quite active on LinkedIn, but you'll also find us on Twitter, Facebook, Instagram and of course, we have a YouTube channel. And so with that, I Thank you for your time and attention and good day.

Segments

Site engagement

Benchmark

Site sentiment

Protocol analytics

Conversation signals

Communication signals

Survey analytics

Oversight

Secure

Compliant

Digital

Accessible

Intuitive

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