IQVIA Holdings Inc. (IQV) Earnings Call Transcript & Summary

Hello, everyone, and welcome to our final session in the Patient Recruitment and Enablement Webinar Series. My name is Leslie Clapp, and I will be moderating today's presentation. A bit about myself. I'm Vice President of Medical Operations of Avacare Clinical Research Network. A site network founded in 2016 by a group of dedicated research professionals to connect patients to novel treatment options and accelerate clinical development through Avacare’s technology-enabled global site network. I'm pleased to bring my 35-plus years of combined clinical search experience in clinical medical practice and academia, medical leadership and clinical research and trial execution in multiple therapeutic indications to my role in providing medical oversight to the Avacare Clinical Research Network. Avacare sites links patients to clinical research at our sites as Avacare creates and fosters more efficient data collection and delivery of trials across a myriad of therapeutic indications. Today's presentation focuses on the site's role in successfully implementing the digitalization of clinical trial operations and how, through strategic site support and specialty services, clinical trials can foster better and more effective workflows among sponsors, sites and patients. We hope that our time together today will be valuable and inspire forward thinking for your clinical trial practices. A bit of housekeeping for today, all audience members are on mute. We will reserve time at the end for Q&A. So please feel free to drop questions in the prompt. We look forward to addressing them at the conclusion of our presentation. A recording of this session will be available for replay shortly following the webinar. I am joined today by 3 amazing colleagues who championed their own passion for the work that they do. Let's meet our expert panel. Welcome panel, Rebecca, Owen and Eric. Why don't you each give a short bit of an intro for our audience today. Rebecca?

Thanks, Leslie. My name is Rebecca Sayers, and I'm a Director within our Patient-Centric Solutions group here at IQVIA. I have over 12 years' experience in clinical research, specifically around site engagement and enablement. And in my current and my past roles, I've been supporting sites with engagement solutions, resourcing solutions in multiple therapeutic areas in all regions conducting clinical research today. I bring some specific experience in hematology and oncology, immunology, neurology, infectious disease, that experiences help me work directly with our customers and sites to develop solutions that help bridge the gap between sites and getting the necessary medicines out to patients today.

And I'm Owen Corbin, and I'm the Senior Director of DCT Regulatory and Data Privacy at IQVIA and I've been at barred attorney for 27 years and in clinical research for 13 years. I am a certified information privacy professional, specializing in Europe and a certified information privacy manager. And I run really the decentralized and the PCS, the patient-centered solutions, privacy team here at IQVIA and the regulatory teams. And really today, I'm talking about the experience that we have gathered in running decentralized clinical trials and digitalized clinical trials and offering patient-centered solutions over the past 4 years in the clinical research space.

And I'm Eric Neely. I'm Senior Director of the Research Nursing Group here at IQVIA. I've been working in the remote research nursing field for the past 7 years, so long before COVID. Worked in over 200 protocols so far and successfully implementing remote research nursing. And today, I'm going to talk a little bit about how to successfully use remote nursing for remote visit strategy and some things to keep in mind when doing so.

Thanks, Eric, and thanks, team. Let's get started. Clinical research has evolved quite a bit in the last handful of years, Today, the Modern trial is inclusive of technology as well as expanded recruitment and site services meant to drive efficiencies within the trial. These approaches and methodologies enable sites with a consultative and supportive services and tools necessary to operationalize successful clinical research. So what does that mean for sites? It means more of an ask is put upon the site as they continue to be [ test ] with helping reduce patient burden while accelerated recruitment enhances and optimizes the ability to find a desired participant for the study, it also uncovers challenges as well. As we learned in the last 2 and the previous 2 webinars, utilizing salient insights helps to better understand the motivations of the trial participant and create a trial journey preferable to them. A thoughtful patient journey helps recruit and retain that study participant within the trial. But what technologies and processes result in more successful partnerships in patient-centric digital trials? Today, we explore the realities of studies and how to connect the sites and the people needed to make clinical trial operations successful by addressing the obstacles and concerns as they pertain to this evolved approach to conducting clinical trials. I would like to hand it off to Rebecca Sayers, IQVIA's Director of Patient Recruitment Strategy. Rebecca, focusing on the site as a key cornerstone to patient-centric research. How does your team help drive success through their comprehensive collaboration with sites so that each member of the study team can work optimally to advance our collective goal of making innovative therapies available to patients. Rebecca?

So I think that the idea of patient centricity certainly starts with our sites. Our sites are the core to finding patients that are in need of the therapies that are under investigation and providing support to sites in the way that IQVIA is able to offer it allows those sites to be extraordinary and perform beyond their potential. And IQVIA, as a partner to our sites, we're working with the -- all of sites coordinating or participating on clinical trials to provide support to make sure that they can meet the goals of our customers. So these staff are global. We're able to identify staff that are either on-site or remote in a variety of countries throughout North America, Europe, Latin America and Asia. We're able to adapt to changing needs and priorities throughout the study or portfolio life cycle. And we're able to really use this partnership with both our sites and our customers to make sure that we're reducing the overall burden on the sites and ensuring that sites can have the personalized experience that they need to support their patients in the way that they want to. So if you can go to the next slide, I think it's very important to put into context the challenges that sites are currently facing with clinical trials. We know that we're asking a lot of our sites right now. And as we've already stated, it is really the responsibility of our sites to find patients, create a patient experience that is conducive to recruiting and retaining our patients to clinical trials. And right now, a lot of sites don't have the necessary staff to be able to do that. And the environment is becoming more and more intense. And so this slide is outlining some of the specific challenges that we've seen our sites experience specifically in the post COVID space. So overall, with resource constraints, we know that the protocols we're asking our sites to work on are becoming more intense and complex. We know that the eligibility criteria as therapeutic needs and therapeutic treatments, increasing specificity and then competing institutional demands, new technologies, they really overuse the available bandwidth at our clinical trial sites. With the increasing complexity, we know with that comes more data. So we're asking our sites to do more and more in terms of volume with the number of patients that need to be recruited and the number of data points that need to be collected. Again, just drawing on that demand for sites. And as we've already covered recruiting and retaining these patients to our clinical trials continues to be difficult. This is already a challenge before COVID, and now we have less people to be able to find this higher specificity of patients for clinical trials. And we know that our customers are -- or that our sponsors are out there with a variety of medicines and different therapeutic needs that they're looking to meet. So the competition for our patients is high. And so with all of this to navigate sites need increasing support to be able to meet the needs of clinical trials today. In addition, we know that we're asking a lot of sites in terms of the number of patients they need to recruit. So not only are they looking at patients that are currently -- belong to their clinic or seeing physicians out their clinic were asking sites to look outside into their community and set up new referral networks, contact their colleagues and also participate in direct-to-patient campaigns, which is going to, again, put increased burden, technology demands, reporting demands on our site and all of this filed together makes it incredibly difficult for sites to participate in the number of trials that we need them to do as an industry. So if you can go to the next slide. This is where I want to explain a little bit about the different services that IQVIA site enablement solutions team can provide to mitigate some of these challenges that we've already talked about. So during COVID and after COVID, through our observation of these challenges, the increasing complexity of the landscape for sites. We understand that to achieve what we're asking sites to achieve on clinical trials overall. But collectively, the staff to accomplish this is not there. So IQVIA has put foresight enablement solutions in terms of a variety of different roles that we can offer to sites to be able to meet the challenges that they have at the protocol level. These roles are applicable throughout the life cycle of a study, and we have a variety of roles at different expertise levels to be able to meet specific needs for our study. The first of those is the Clinical Research Technician. It's a specialty role that we recently designed to meet data entry needs. As we've already touched on, the data entry burden on sites is increasing. And with our customers time lines for database lock and really getting the results in a timely fashion, it's important that sites have the resources they need to enter that data. Our Research Assistant role is actually one of IQVIA's most popular site enablement solutions roles. And it really helps us target more administrative tasks at the site, but if the site can delegate those to a research assistant for a specific study, it frees up the sites, really establish and train staff to complete some of the more complex tests for the clinical trials that they're working on. Our Study Coordinator role is also a vital role to our suite of offerings as is the nurse role. These roles are more specific to interacting with patients directly. And when sites are looking to expand their recruitment capabilities or be able to meet higher visit schedule needs, these roles are really critical in enabling sites to do that. Finally, we've recently rolled out our CNS and Neuropsychiatric Rater role, which is really meeting a niche need in the neurology and psychiatry space to really understand that with the increasing amount of studies in these therapeutic areas, in particular, the requirement to have raters is a challenge for a lot of sites, and we know that the patients within these therapeutic areas can often be upsides that either have greater resources that are not available to be delegated any more responsibilities on clinical trials or they just don't have that previous rater experience at that site. And so IQVIA can then offer the rater role to sites and really enable them to take on more studies or be able to enroll more patients or participate in additional studies. So on the next slide, what I want to overview is the experience that our site enablement solutions team brings. IQVIA has been offering the service for the past 3 years. And during that time, we've been able to place over 1,400 qualified research professionals at over 400 sites globally. This has been over 25 countries on 6 continents and spans at this point, over 80 protocols. The service really grew from, obviously, a small number of customers that we are working with. And as we've already discussed, we know this need is significant and we know that it's widespread across multiple therapeutic areas and studies. So our business has really grown. We have more than 25 customers that we worked with in site enablement solutions, and this is now spanning 8 different therapeutic areas. So to wrap up our discussion of site enablement solutions here at IQVIA, I want to highlight a couple of benefits that we've been able to identify from our sites. On the slide here, you'll see some quotes from a research manager and site director that we recently worked with on COVID trials. And you can see that their feedback is highly positive, and the sites really do enjoy working with our resources. And in total, the benefits that we're able to see from that, again, kind of going back to that idea of patient centricity is that by reducing some of the more administrative and complexity burden from our sites, our sites are now able to spend more time with their patients. They're able to really optimize how they're conducting each individual trial that their site is offering to patients through the flexible and scalable options that we're able to provide to them, we're really able to work directly with sites to understand what their needs are, is it that they need more support with the technology pieces that are part of those individual trials? Is it making sure that they are able to coordinate the decentralized aspects of a clinical trial because that might not be something that they're used to. So we really want to meet sites where they are to free up their most valuable resources to do that most important work with patients. And so it really does serve to increase the site resource capacity. Overall, the tangible benefits that we see from this are results as in increased patient recruitment, increased contribution of sites with site enablement solutions resources in terms of the overall patient recruitment burden for the site. We do see that our sites have excellent data entry time lines. And really, as we're looking at sites, and we're giving them more resources to do more and to produce more it's giving them more data, more patients to work with. And so in turn, it really is an opportunity to understand how we're going to really mitigate compliance and handling of personal data. And so with that, I do want to hand it over to Owen to really cover this topic, especially as we start pushing the boundaries on how we're working with sites in the space.

Thanks for the question, Rebecca. That's a great question. And there's really a couple of things we need to level set on what we're talking about assessments conducted outside of the site. And one of those is decentralized clinical trials and what we mean by that. So any clinical trial that leverages technologies and specialized services to engage participants in the community and facilitate patient-centric care. This includes pre-screening, telemedicine visits, at-home treatment or mobile research nurses and staff is categorized as a decentralized clinical trial. A decentralized approach to research aims to bring the patient voice to the trial, reduce the burden on patients and increase representative participation by expanding traditional site boundaries to deliver a more personalized trial experience. IQVIA is really the leader in the conducting of decentralized clinical trials. We currently have over 400 active decentralized clinical trials on the way in over 75 countries and over 30 indications with 17 therapeutic areas. There are currently over 327,000 active participants in decentralized clinical trials of IQVIA. There are over 2,500 nurses providing study support globally to participants and sites. Next slide. The importance of this experience is because we gather all of that experience with the sites, with the participants, with the regulatory authorities of the basic conduct of the study into an enriched regulatory intelligence database. So we start with a country-level intelligence. So this is the base level of intelligence with 85 countries, where we engage subject matter experts and learn from them about the regulatory requirements for conducting clinical trials, for introducing technology as clinical trials and their operational lessons learned and they've conducted clinical trials with technologies and incorporate that as the baseline. And then from there, add in a layer in regulatory and EC engagement of over 450 protocols. We add in the engagements that we had in giving consulting to ethics, committees or regulatory authorities in their DCT approaches. We also layer in operational intelligence. We have actively over 50 subject matter experts that work on studies in real time, cataloging their experience across the world. So there's regional teams in Asia Pacific, Europe, Latin America and the U.S. that gather the operational experience of decentralized clinical trials and a digital clinical trial, so including any kind of technology in the conduct of the study, whether that's at the site or remotely, as remote assessment and include the operational intelligence into the design of the future studies and in the conduct of the future study. So that we ensure that the study is designed in a way, the protocols are written in a way, the regulatory packs are addressed in a way that we can include the operational intelligence and the regulatory intelligence moving forward. We also have thought leadership that shapes the industry. So of those subject matter experts that are engaging in panels, white papers, blogs and webinars such as these, participate in conferences that provide comments to the regulatory authorities and to the ethics committees on either their draft, guidance or their comments that affected the use of clinical trials, use of technologies and clinical trials or in the decentralized approach to clinical trials, so including assessments that are conducted outside of the homes or if they're including, for instance, clinical professionals in conducting assessments in the home. Next slide. I would say the 3 things I'm often asked, where do you see regulatory and privacy compliance today in the conduct of decentralized clinical trials or digital clinical trials, where technology is included in the conduct of clinical trial. And I'll say from an overarching perspective, there are 3 things that I think about when I could answer that question. And one is the current pace of regulatory -- regulators letting us know their thinking and relaying how we should be conducting these studies is really unprecedented that I've seen in the industry. I would say the second thing is that it's in flux, and that is as we conduct more and more clinical trials, we learn more and more about how those clinical trials can be conducted in a way more efficiently, how they can be conducted so that they are more clear to the regulatory authorities. So these insights as we're conducting these as you've seen over 400 clinical trials in over 75 countries that's why this embedded clinical trial intelligence is really so important to the conduct of the clinical trials. And that's why as the industry leader in conducting these clinical trials globally, that changing environment is why it is so crucial to have a subject matter experts watching and learning and then feeding that information back in the intelligence database. And I think that's part of the -- it's the know. And can stay continuously aware of what's happening. We literally have subject matter experts whose jobs are to engage regulatory authorities, to engage ethics committees, to engage thought leadership, and to watch the regulations that are coming out in the marketplace, that are coming out -- that affect decentralized clinical trials, that affect site enablement solutions, that affects digitalized clinical process, including technologies of this clinical trials. So those 3 things, I think, are really the status of where we are today with regulatory combined. So why it's so important to be engaged in not only the watching and the knowing, but the recording what we're doing as we're running these decentralized clinical trials and digital trials to ensure that we apply those lessons forward. When I say that the experience that we have with currently regulatory authorities, letting us know how they'd like us to conduct the studies unprecedented. This is just a snapshot of some of the guidance, it's certainly not all of the guidances that have been released just in the last 6 months. And as you'll see here, there's over 10 guidances in 6 months that are specifically related to the conduct of decentralized clinical trials or digitalized clinical trials so the electronic capture of clinical trial information. A big one that's dropped recently, of course, the ICH draft GCP, R3 has come out, and there are anticipated to be quite a few new guidances in that GCP related to the conducted decentralized clinical trials and the conduct of clinical trials that included technology. As we're looking and watching and learning, I'd say that there are basically 5 overarching guidances that we would say form the backbone. So maybe the structure of regulatory and privacy compliance within clinical trials. Certainly, there are an innumerable number of others and specifically. But these are the ones that I think as we think about compliance overall that we think about. And you can go back and read the slides to really look at the specific guidance in and of themselves. But high-level FDA requirements of course, GCP, always GCP. The EMA guidances and as they are interpreted through the new clinical trial regulation and of course, GDPR. In the U.S., of course, we have states that are issuing new privacy requirements quite frequently in the last couple of years. So those also go to include or included in the fabric of that regulatory guidance. When we review these guidances, and this is really what we cover in the next slide, there are 4 big takeaways. And of course, there are lots of specifics in each of the regulatory guidance at each of the regulatory laws. So I don't mean to gloss over those -- but just in terms of general takeaways. But I think, generally, what do I talk to technology developers and what do I talk to sites, what do I talk to sponsors about? These are the things, data integrity, make sure that you're -- the technology that you're building can collect and maintain data in a secure manner. So data integrity with patient safety, it is part of the basic of GCP. So that's validation testing to ensure that information is secure. The access is restricted. So the requirements for that data integrity are really pivotal to what we're doing here in clinical research. Confidentiality. So computerized systems need to ensure that the confidentiality of the identity of the patient needs to be protected. And that's -- whether that's in the United States, EU that is a basic GCP requirement. So if you read these regulations, you'll see these 2 things echo, data integrity, confidentiality, of course pair with patient safety. The third thing is due diligence. And this is the thing we talked about a moment ago earlier in the slides, that the due diligence of a sponsor being able or be required to ensure that any computerized system that they are introducing into a clinical trial, whether it's in a decentralized clinical trial, digital solution that they meet the applicable regulatory and study requirements. So does this meet the applicable regulations and is it fit for the purpose for which it's being used? And really that fourth one, the privacy and cross-border data transfers. And we live in a world where a lot of systems process data in multiple countries. So what that means is the data that's collected in one country is moved to another country for processing, whether that means a success by somebody within another country or it's moved within a database within that country. It's a reality of the conduct of a global study. And before you deploy these technologies in your studies or the site enablement solutions that are these roles that support sites often from other countries, the question needs to be asked about the laws or that cross-border data transfer in the country from which the data originates and the countries to which the data is being moved. So this is something the awareness of which is -- I can't stress on how important this is to consider when you are designing your study and when you're considering the vendors and your partners for the study. So this is actually one of my favorite quotes. So the sponsor is ultimately responsible for the validation of the computerized systems used in the clinical trials when the sponsors want to introduce that technology. Similarly, if the investigator of the site is introducing the technology, then the investigator is responsible to ensure that the system has been validated. Now either may rely on the qualification documentation provided by the vendor, if the sponsor or the vendor of the site has determined that, that vendor conducts adequate due diligence process. But they may have to perform additional qualification/validations activity based on the documentation, risk assessment that they received from the vendor. What does all this mean? It means that as a sponsor, introducing a technology into a clinical trial, that sponsor needs to conduct adequate due diligence so that they can answer the question affirmatively that this technology does, in fact, meet applicable regulatory requirements and is fit for the purpose for which it's intended. Similarly, if the site is introducing technology, they have the same burden. Which really brings me to the mature technology partner. So that is a decentralized clinical trial partner or a digital clinical trials partner. And what to expect when you have a mature technology partner. So that matured technology depart -- the mature technology partner can bring to the table, design documentation, so documentation of the privacy by design, how the technology was designed, they can include validation documentation. So as we were speaking earlier, about the requirements for data integrity, for confidentiality, for privacy. All of those requirements being turned into technical requirements that are then validated so that the system can supply validation testing to ensure that the system does meet those applicable requirements. I think equally important is a mature technology partner comes to the table with risk assessments. They come to the table with data processing impact assessments, with privacy impact assessments, with transfer impact assessments. They come to the table being willing to talk about the risks that may be present with the use of the technology and the transfer of the data and their technical and operational measures that they've employed to minimize those risks. And they'll come to the table with SOPs. So they'll come to the table with these operational practices that mitigate the risk to data integrity, they mitigate the risk to confidentiality and privacy. And they will talk to you about the cross-border data transfers, they will talk to you about the SDLC and the Data Life Cycle and how that data is maintained in the system. And I think this is probably one of the most important parts when you are conducting the due diligence. With a mature technology partner is they'll be able to provide demonstrable results. So this is a technology that has been subject to audits and inspections globally. This is a technology that has been used in multiple therapeutic areas. Your mature technology partner has been through multiple studies in multiple countries and is able to articulate how the technology functions in each of those areas. IQVIA is definitely a mature technology partner, and we've gone a step further in addition to just going through due diligence or just having packets that are able to walk a sponsor through the requirements for the applicable requirements for regulatory compliance or privacy requirements and walking through that validation, validation testing, walking through SOPs. We've gone the additional step of having our systems validated by a third party to meet GDPR requirements. And that's an important step because what that means is that our systems meet a privacy requirement that it meets the standard of majority of the privacy requirements globally. And it's certainly not something that we're required to do, but as a mature technology partner, we wanted to be able to demonstrate that commitment to privacy and to regulatory compliance. And from here, I want to talk -- allow Eric to answer a couple of questions. And one of them, Eric, is the growing trend in clinical research, as we've just talked about, the protocol assessment is conducted outside the sites. More and more mobile clinicians are used to support the sites and alleviate the patient burdens in clinical trials. So Eric, this question is for you. Can you talk to us about how mobile clinicians alleviate the burden for sites in clinical trials, and what learnings IQVIA has gained in operationalizing these mobile clinical assessments?

Thanks very much, Owen. I think that's a great question to talk about where we are today as a society and what sort of services are needed for upgrading the clinical research process to today's day and age. And I think about today really being an Amazon Prime-based world where individuals are very accustomed to fast, high-quality tailored services for their needs. But even with all these personal and time-saving advances in folks lives, we still have people that are busier than ever to do different things or new things in their day to day. And so participating in a clinical trial can be very cumbersome for them, especially if they have an indication on top of everything that limits their involvement to their mobility even more so. So because of this, we should really be doing everything we possibly can to have a patient-centric model. And as we see with some of these stats on the screen here, for many participants, potential participants, they're just not willing to drive a far distance to get to the site in order to participate in trial. Especially if we have a very complex protocol with many different assessments and many different visits that are required. And pretty much all of us on this call have been to the clinic at some point in our lives and we know how much waiting is involved. When we're there in the clinic, we are on not necessarily a very tight schedule because things can always be delayed, we can always be pushed back until a lot of our time can end up just being waiting and waiting to be seen or waiting to move from one clinician to the next. And so by using services such as remote nurse visits, we see much better retention in the trial by focusing to their lifestyle and their needs. And so next slide, please. With remote visits, we've seen quite a transition since COVID, pre-COVID, even though these services have been around for decades we saw these services tailored more to rare diseases, a few virtual trials, although not many, some traveler rater and assessment teams, but very niche overall. Most people, if you ask them, what decentralized trials are, what remote visits entail. They wouldn't know exactly how to answer that question. But as we move into the COVID world in 2020 and 2021, we quickly changed and people needed to adapt very fast in the operations world for clinical research. And so this was a period of what I call the SOS period, the save our studies period because the protocol could not continue without having these decentralized elements because sites were shutting down and personnel for the sites were more limited than ever before. And so now we're in a current phase of really growing our knowledge base. Most folks still haven't had direct DCT experience with remote visits or some of the other elements we've talked about today. So they're really wanting to grow their knowledge base to pilot some of these services, educate themselves and learn more. And the way that I see it, the next step is going to be instead of constantly exploring what these services look like or how to use them, it's just going to be more baked in. There's going to be a broader understanding across the clinical research industry as a whole to know how to utilize these services and when to utilize these services in a fit-for-purpose manner. Next slide, please. And so when sites think about the procedures that are going to some of these remote clinicians, a lot of times, they'll have a common misconception that the entire protocol or the bulk of the protocol will be given to remote clinicians that they're going to lose control of the study, and they just won't be able to have eyes on and hands on the participants in a way that they normally would. And this is a very common misconception. Really when these types of services are added, we are just adding to the site staff, as Rebecca talked about before and for the procedures that we're performing in the home, they're typically very commonly outsourced procedures. So if we look at the left of this slide here, when we think about things like specimen collection, most clinicians and physicians are very accustomed to sending their patients to third-party labs to have their blood drawn or very accustomed to sending their patients to infusion centers for drug administration or even having drugs sent straight to the home. And with some of the technologies we've talked about too, it's becoming more and more uncommon to have eCOA and e-questionnaires in the home utilized rather than really forcing the participant to return to the site every time. We still have, on the right side here for most of the protocols that are being hybridized to site visits and these are the visits where that site staff and the physician can really use their experience, their knowledge, their expertise to the best use of their time so that they are focusing on procedures that they need to perform as a physician. Whether it's a full exam, whether there's some complex decision-making that's involved rather it's a high-risk study that maybe isn't a great fit for decentralizing or using remote nurses and should still be done at the site, they're still performing those activities. Obviously, complex assessments such as imaging, MRIs, CTs, things like that are still happening at the site, too. So when we look in the middle here, we're really designing a thoughtful fit-for-purpose study that's keeping the sites time in mind and the participants time in mind. And next slide, please. And when we're looking over protocols and deciding, well, what could we possibly have collected in the home or done in the home. There's usually 3 main buckets that anyone should be considering for a potential decentralization. And that is collecting data, collecting specimen for some sort of either investigational product or medical device type support with specimen collections. These are usually what we see the most of our protocols that we or anyone else work on in the industry would have some element of specimen collection, whether it's complex PK draws that require the participant to stay around for hours or even days at a time to have that time sampling or just standard specimens, blood /urine /feces that need to be collected. We do see a lot of IP support and medical device support to where our clinicians will have specialty training in order to support the participant in the home, where they're comfortable on a timetable that works for them and really fits their busy lives, whether it's a night time because they're working during the day or weekend because they're busy during the entire week, something that is going to both fit their schedule and fit the protocol schedule so that we're reducing deviations for those missed site visits or [ home ] visits. And next slide, please. And this slide, I know it's busy, but I think it's a really important one to think about as one is considering utilizing these services or writing them into the protocol, how are we going to get the most use of the service, the most adoption from science, the most adoption for participants. And with this, I think of what the value is having this type of service with the participant or with the site. And I'd like to think of it as an intrinsic value, baked in value that they are immediately going to see when trying something that's potentially new or different for them. So if we look at the right side of this image here, when we look at the greater drivers to adoption, we see right on top there sponsor protocol requirement and required for feasibility. There's a lot of studies that we see that just can't be done at the site for any number of reasons that we really have to have some sort of remote clinical element added to the study to derisk the study as much as possible and have the most success I've already talked about the commonly outsourced scope, making sure that we're not adding really any additional risk to these remote visits that wouldn't be present at the site. We always want to look at, as Owen was saying, the risk profile of the study and whether this can be successfully added to a study. So it does need to be something that can be done in the home safely and with high fidelity. Patient centricity, of course, we've talked about that a lot today. And really just the site and the PI persona having that great communication with the site so that they can get some education through the process and be able to ask questions and understand how this is going to benefit them. So when we think about best practices for sites and participants, we do think about early design consultation, making sure we're discussing this with the sponsor very early on in the game so that we can set up the trial for success, having that one-on-one site training and ongoing support as we've talked about as well, user-friendly technology, making sure that it's something that is easy to use for the site. We can't have the cure, be more of a burden than the original problem for what we're trying to fix here, making sure it's fit for purpose and making sure that ourselves or any vendor that's utilized on the study is really well incorporated in the communication and the design of the study. And then next slide, please. So while the centralized trials and remote nursing may seem new or strange to many patients and sites, recent polls found that many investigators and patients were either comfortable or even preferred these options. And so these numbers here that we see on the screen are based on a 2020 IQVIA survey of patients although 2020 seems like a distant memory at this point, it shows that the shift in ways we execute clinical trials was accepted by patients and sites and is also preferred in many cases. And so mobile services can help the site elevate the quality of care by simplifying site operations and efficiencies data quality and collections. And if we're going to have a patient-centric study, and we need to account for all the groups and services involved to make the trials work smarter. As we mentioned throughout the session, having the resources and services that support the site's journey and experience is necessary to create a true study success today and into the future.

As my colleagues presented clinical research at an exciting time. Coupling trials with technology and services will only enhance the experience for better outcomes for all involved. As study enrollment and retention continue to be a struggle within our industry, sites won't be successful if they stick with the same status quo of yesterday's clinical trial. Trials have evolved for sites to evolve with trial operations, their obstacles must be addressed and accounted for in order to foster a culture of quality and elevated site operations. I'd like to thank all those who joined us today and for tuning in. We appreciate the time you've spent with us.

As mentioned earlier, if you have a question, please submit it in the Q&A box. Jessica will be monitoring questions as they come in. [Operator Instructions]. We will follow up shortly. I think I see the first question that has come in, and I'll be moderating the first few and then pass it off to Jessica, my colleague, who will handle the rest. Owen, this one is for you. A digitalized clinical trial is something complex and as clinical trials have evolved, we want to know what additional support do sites and participants need to ensure success?

Thanks, Leslie. That's a great question. And as we continue to move assessments outside of the site, the sites do need some additional support. They're often seeing a higher volume of participants. They're often participating in a higher volume of studies. So they do require some additional support to navigate those volumes, but also to assist the participants as the participants navigate the technology. So at IQVIA, we have several options of site enablement solutions, whether that's the patient recruitment, as you mentioned earlier, where patients can be contacted and identified and prescreened and sent to the sites or embedded site solutions for clinical trial coordinators to be at the site to assist with studies or remote study coordinators who can help with the site, the site with a digitalized or decentralized clinical trial studies. We also have 24/7 support available for each of the technologies for protocol support and for participant support. So I think it's an important question as these -- as the assessments move outside of the sites as we engage clinical -- clinicians to engage participants at the site, these mobile clinicians, that we do talk about the sites and how we can set them up for success. And these roles play an important part of that.

Well, you led me to the second question, and you kind of answered it. That is this is a lot for sites to absorb. Does the site becomes tech support? What kinds of technology solutions and support services does IQVIA offer to get site launched when using the decentralized or digitalized model?

And I think it's an important consideration because sites already have a lot that they're handling to get a participant through a protocol. And we don't want to add to that being technical support . And after all, they're not an expert in the various technologies that may be included on their study. We're well aware that this study may not be the only study being conducted at this particular site. So we want to again set the site up for success. So how do we do that? So we have investigator training that we engage in for each of the technologies that we provide to the site. We have study assistance that are available remotely. They can assist the participant or the site with interacting with that technology. And as I mentioned in the previous question, we have 24/7 support -- tech support available in multiple languages to assist the sites and assist the participants in navigating these technologies.