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

Hi, everyone, and welcome to today's live broadcast, Site Support: The Cornerstone of the Digitalization of Clinical Trials. My name is Andy Studna, the editor of Applied Clinical Trials, and I will be your moderator for today's event. We are pleased to bring you this webcast presented by Applied Clinical Trials and sponsored by IQVIA. Before we begin, I would like to share a statement from our sponsor. IQVIA creates intelligent connections to deliver powerful insights with speed and agility, enabling customers to accelerate the clinical development and commercialization of innovative medical treatments that improve health care outcomes for patients. With approximately 82,000 employees, IQVIA conducts operations in more than 100 countries. You can learn more by logging on at www.iqvia.com. We have a few housekeeping notes before we begin today. This webcast is designed to be interactive, and we encourage you to ask questions throughout the event. [Operator Instructions] I would now like to take some time to introduce our speakers for today. We are pleased to be joined today by Eric Klaver, Kelly Sanford and Kat Burns. First, I would like to introduce Eric Klaver. As DCT, Regulatory Director at IQVIA, Eric brings almost 30 years of clinical research experience and roles varying from data management to post-trial access. His focus has been on compliance and clinical trials through training and auditing. He has trained clinical research staff literally around the world. Currently, Eric focuses on the continued compliance of the IQVIA DCT strategy and platform. Welcome Eric. Next, I would like to introduce Kelly Sanford. Kelly is the Head of Site Operations, Site Enablement Solutions and Decentralized Trials, part of the patient-centric solutions at IQVIA. In her role, she supports sites and study participants in decentralized trial delivery, leading a team of remote study coordinators and remote study assistant team members. Kelly joined IQVIA in 2002 and has served in numerous roles within clinical research as a study coordinator, CRA, clinical lead, clinical project manager and management roles. Prior to joining IQVIA DCT, she served an oversight and line management for clinical weeds. Thank you for joining us today, Kelly. And last but not least, I would like to introduce Kat Burns. She is a Project Manager for the Research Nursing and Phlebotomy Solutions, or the NRPS (sic) [ RNPS ]. Kat oversees the start-up process for RNPS projects focusing on operationalizing the trial assessments and bringing the study to the patient's home as an extension of the investigator site. Kat has over 10 years of clinical research experience, having focused the last 5 years in the home health care space of clinical trials and building this type of service for optimizing patient access to clinical trials. Welcome. I would now like to hand the presentation off to our first presenter, IQVIA's privacy expert, Eric Klaver. Eric, please take it away.

Thank you for that introduction, Andy. Yes, a very good day to all of you. Today, we will be talking about the site support and the cornerstone of the digitalization of clinical trials. Over time, clinical trials have moved to further and further digitalization and it got -- it's getting to a point where it's quite a significant amount of technology being utilized in clinical trials. It evolved over time. As you may well know, we started with paper CRF, went to eCRFs, we had paper trial master files move to electronic trial master files and a lot of things are being digitized over time. A number of aspects in clinical trials are being decentralized participants no longer necessarily need to go to sites for everything that needs to happen for the conduct of a clinical trial. So over time, that has progressed significantly. Over 20 years ago, home nursing already started to be part of clinical clouds as well as connected devices. Question is, eConsent was developed over 2 decades ago. Risk-based monitoring became part of a more decentralized approach to clinical trials, but actual fully virtual trials didn't start until early 2010s. Now we get into a point where DCTs, decentralized clinical trial, that term is almost outdated, if you will. It kind of suggests that we're talking about a totally different type of trial than we are. It is a traditional trial and elements can be decentralized, and that means that technology is helping us to get to a more decentralized and a more patient-centric way of conducting our trials. With that comes a lot of tech that we provide to sites and that participants have to work with and as is important at that point is that we don't just throw sites -- throw technology at sites and at participants, but we ensure that they are supported in being successful. We need to enable sites and participants to be successful in the conduct of their trial. So that path brought us to a patient-centric way of conducting clinical trials. And that is the utilization of a lot of digital tools that we help on that. We've seen that now with, for example, the home nursing that's happening. But nurses come to people's homes, and we need to make sure that they have to correct information and can connect to the investigator quickly as well. Now that needs to be done in a way that, of course, is compliant with all the regulations and guidelines that are out there. And that is a fast evolving landscape of regulations and guidances out there. And it's important to be compliant with the regulations that are currently out there, because we need to make sure that the results that we get from these trials are, of course, reliable. But we need to make sure that we protect the participants right safety well-being. We need to protect their confidentiality. We need to protect their privacy. And by being compliant with all the aspects and all the elements of the regulators and the guidelines, we ensure that the regulators understand what it is that is being done and how to interpret the data. So by voice of the regulators at the EMA stakeholder meeting, they indicated that data reviewers should be unable to understand where the data comes from and how that should be interpreted. So very important to know that we -- everything that is being done is in compliance with the regulatory and guidance out there. But as you can see, a lot of that has changed over the past year. If you go back to December last year towards only the first half of this year, a number of guidances have been released in different areas of the world. And a lot of that is currently being harmonized in the ICH GCP updates. There are 3 [ rivers ] in 3 update of ICH GCP that's currently in draft. There will be a second part of that coming out, hopefully, within this year, but most likely early next year, where -- which may contain more information on how nontraditional forms of trial conducts can be done. So we need to make sure that we know what is happening. We need to be in the now of everything that's going on, we need to know that it's in flux, it will change, but the core of how we conduct clinical trials is still the same. We still have data that needs to be collected, that represents the participant group, but we're trying to get this representative data from. How we enable participants and sites to be successful on that, on that, my colleague will continue. Kelly?

Thank you, Eric for that wonderful overview. So as we know, our site level challenges remain for our sites in terms of how we execute. There are so many competing challenges that sites have that they have to deal with every day. The first is resource constraints. We have very intensive protocols that taking a large amount of time is only increasing complex eligibility criteria, many, many internal as well as kind of technology constraints. There's just a lot that is taking time from our sites regarding just their abilities to conduct the research just from a resource constraint. We have a very large data backlog that's coming to sites. Our sites are at a point now where they're just slimming and the amount of information they're having to collect even quicker and quicker than before. We have a very large commitment to try to recruit all of these studies. We need to keep patients engaged and that's important research and to retain them. And that remains difficult in this environment. And as we all know, we have many competing trials for these important indications. Our high-performing sites, all of our sites really are working across multiple studies, different sponsors, indications everyone is stretched, trying to meet the important demands of clinical research, and it's really pushing our sights to the edge. And with our different methods, decentralized methods, moving some of these processes outside of the traditional side, we really have kind of a reach out to community patients or looking beyond the institution in terms of the patients that our sites are seeing. And so that adds complexity to execution, it adds just kind of additional workload that already our stretched sites are managing. So IQVIA has dedicated operational support for sites that could help address many of these concerns, both from a traditional method as well as from a remote method for decentralized trial operations. We have global resource staff that can really help sites wherever they are and whatever way they need. Our goal is to reduce your overall burden in terms of working on these clinical trials. And we do this by building trust, understanding what your needs are, hearing you clearly in terms of what your concerns are and helping come to the table with a resource that can help address some of those needs that can help you participate in more clinical trials. We hear regularly that sites want to participate more. They just don't have the staff to commit to the expectations of the study and don't want to take on something they know they can't deliver against. And our teams can help really fill those gaps in terms of trying to help you take on more studies and help us move more quickly through this really important research that we do. So what we try to do is to come to the table as a partner. So we hear your needs. We hear our sponsor needs, and we work together to try to create a solution that helps complement your sites in terms of executing clinical studies. So at IQVIA, we strive to set up a solution that really serves each study and sites need, all the way from establishing an appropriate trial strategy, trying to keep that study ends in mind, keeping in mind all of the challenges that our sites that our patients have with participation in the clinical trial. We work to set up a successful trial strategy in alignment with our sponsors, providing all of our expertise, as Eric mentioned, in terms of the regulatory landscape as well as our execution and leading us to all the way to retaining the patient at the end of the study. So each option that you see here kind of addresses the specific area of need. We work together to establish an appropriate trial strategy, which is usually a mix of the technology as well as a person, the people behind the technology. We help set slides up for success through site readiness. We engage and refer patients, so we try to identify the patient and to get that right patient to your site. We also have the ability to complement site resources with study execution. So both from a traditional, more traditional on-site type resource all the way to a kind of a fully remote coordinator or mobile nursing solution. So we believe we're complementing that. And we work to retain that patient, so for our technology and our patient engagement activities. The top bar here talks a little bit about the technology that we provide. So there's a lot of different options here. not all technologies work well on each study. And so we look to be a thoughtful partner in terms of establishing what those technologies are that best suite the sponsor and the site needs. And at the bottom bar, we talk about the different kind of resources that we do. And so you can see here that we can do a lot of different things that help build the needs of the sites and help your sites work better. So we can do everything from visit scheduling, following up with patients, payments, as I said before, around mobile research nursing. We have the ability to help support our different kinds of clinical trial execution with a kind of a concierge-type resource, so someone to hold your hand through the technology. And on the right hand really talks about the breadth of the different kind of resource we can provide. So it can be all the way from like a research technician that supports data entry all the way to maybe a neuropsychiatric CNS radar that can help really with some of those critical needs. So -- and I wanted to talk with Kat around the idea of as we optimize site to do more, how do we incorporate compliance and protect personal data as clinical trials now move outside of traditional site boundaries. So Kat, I was wondering if you could speak a little bit more about patient centricity and how we keep these -- this important topic in mind as we progress with clinical research.

Thank you, Kelly. Yes, happy to. As both Eric and Kelly previously mentioned, the complexity at today's clinical research bring are evolving, and we still strive for a patient-centric model to be able to use across the board for various therapeutics, study populations at trial sizes and so on. As seen in the data points using remote visits and decentralized trials can be a solution to ensuring a wider net of patients are able to participate in those that do participate are able to continue in the trial. So as you can see, in turn, this would lead to higher enrollment rates and better retention within the trial. Enrollment rates are being increased by including the patients from further away or are time restricted and may not have considered the participation in that trial otherwise. Patient burden is eased by removing the travel and wait times and not having to be at the site for those waiting periods. And then furthermore, in today's world, this type of convenience is often expected. And we have designed our research nursing services to enable patients to have the choice and offer protocol-required study aid to sites that ensure the patient's compliance and accurate data points are captured. So what is RNPS and the best cases when studies use RNPS, what are the best studies that work for it and why even choose RNPS as an IQVIA in-house solution to do centralized clinical research visits? In short, as a group, we have completed thousands of home visits over the course of multitude of clinical trials for very sponsor companies, patient populations, investigational agents and protocols with a diversity of scopes. As mentioned before, the landscape continues to change and evolve, and every trial is unique. We listened to our industry in the investigator sites to build trust and understanding of our services and customize our processes to the needs of the protocol given that each protocol is so unique. We integrate our services with cross-functional study teams and the investigator sites for optimal efficiencies. As a result and in line with the bullets listed on the left-hand side, we work with our lab partners for our manual instructions, kit building solutions and specimen logistics, getting the samples from the patient home through the central lab or wherever the analysis is. Similarly, we aligned the study drug scope with the protocol guidance for IMP anything that's involved with oversight or infusion injection or even observation periods. And finally, as an extension of the investigator sites, nurses collect the health data and study data to allow for the PI oversight of their patients' health and well-being. So we want to think of ourselves as more of an extension of the site and a tool for decide to reach the patients in their home. Understanding that physical and virtual interaction with investigator sites is an essential part of the trial activities, we aim to increase in clinical trial experience and work closely with the investigator sites to balance out that reaching the patients in their home and keeping that virtual connection with the patient and the PI directly. So with that being said, we're going to now cross over into some questions that we often encounter from the industry. And I will pass it on to Eric to ask the questions.

Thank you, Kat. Yes, we've collected a few questions that we often encounter and let's talk about those topics. So question number one, the adoption of these services and supports are becoming more sensible to better outcomes. But what does that mean when we're thinking differently about digitalized clinical trials? Shall I start with Kelly?

Sure. Thanks, Eric. So as the complexity of execution of these trials becomes more and more present, it really -- you can't underestimate the people component in digitalized clinical trials. I think we tend to focus a lot on the technical components of digitalized clinical trials, but there's always people. People are important to make sure your sites understand all of the integrations, how all of the different tools work together. They're important in terms of serving different needs. And so we have different kinds of studies that are coming to us that offer remote enablement. And so that can be someone, who is remotely dialing into a telemedicine visit or it can be a person like from the RNPS team that can go to a patient's home in terms of executing clinical trials, still having that personal connection, but in a different way. And so I think as an industry, are moving from that tech focus and understanding more that really the people are integral to success in digitalized clinical trials. And I guess kind of my first thought. Kat, do you have additional thoughts to share?

No, just to go on that, yes, every protocol is customized. So as I said before and as Kelly said, it is people that we are serving. We are serving the people of the investigator sites and the patients, the ultimate product of the clinical trial. And we're sending people to those patients. So we are working a lot with people. And as I said before, we listen to the site. So yes, we need to adapt to the protocol itself. But then each site has their own way of doing things. And we understand that, and we hear you and we customize accordingly with our processes to make sure that we meet your expectations, not just a protocol, your expectations as well as the patients and how you prefer to serve our patients.

Yes. Well, we customize the trials, but we also, with that, want to enable asset before, enable sites and participants to be successful. So as we optimize sites, they do more like move beyond the 4 walls of their traditional site, go outside of the traditional side boundaries. How do we incorporate compliance and protecting personal data? That's a question that we do get a lot, because we use technical and digital solutions that are often provided by the sponsor. And therewith, participant data is moved outside of those site foundries. And with that, we need to make sure that both the privacy of participants are protected as well as the confidentiality of the participants are protected. So it's quite important to ensure that all the privacy regulations as well as the confidentiality expectations are being upheld. Kelly, do you want to add anything to that?

Thanks, Eric. So as we think about moving beyond our traditional 4 walls of a site, it's really important that we, by design, set of our processes and practices to keep in mind compliance and protection of personal data. One key way that we do that is through the process through the systems that we use to execute our work. All the systems that we use, we take care to assure that they are at the high level of standard. We also work with our sites and understand what their particular requirements are to -- that they are -- how they utilize these things. And so we try to assure that we marry both from a kind of an overall sponsor provided usually platform, as well as what sites expect out of us to work in assuring compliance and protection of the personal data of participants.

Yes, indeed, thank you, Kelly. And you're saying the things that are quite important in this case, which is that not just quality by design, but privacy by design. You need to make sure you're making these points very well, but we don't just live up to the requirements of the regulators. But also live up to the minimum standards that the hospitals require of the systems that can be used to house that data that basically is an extension of their hospital platforms that they work with. So excellent points there. As we decentralize components, that could be great, but how do we make sure that we are successful in that and a new way of conducting trials? That is a question we get a lot. And I think with that, particularly, we're talking about things that are being remotely done, we don't have a participant sitting right opposite us to -- as an investigator to deal with. We have nurses going to homes. We have to make sure that all the safety alerts are appropriately reaching the investigator on time. How are we ensuring that we're successful in this more modern way, more digitized way of conducting the trial, Kat, do you want to comment on that?

Yes. Thank you, Eric. So that's a great question that we do get a lot as Eric has said. We trained the nurses, very specific to the protocol, very specific to the scope that they will be completing in the home and also completing regular trainings towards GCP, GDP, IATA, anything that would ensure that successfulness of the trial activities within the home. We take -- try to take consider everything that could possibly happen. If they're doing dosing or IMP-related items and assessments, then we want to make sure that they are well versed in the protocol and also the pharmacy manual itself. What are the guidelines for that, and it seems simple, but it is really important that we train to those specific tasks. They are within nurse scope. They are very trained individuals. We make sure the vet and release interview our nurses that we deploy into the home that they are a right fit. If it's a pediatric study, do they have the right pregrounding experience for that type of population, whether it be oncology and have the -- what to look out for those trials depending on what the assessment is. Is it a simple blood draw that we're doing for the home visit, which is really hopeful to not have a patient go to a site for one blood draw and keeping them at the home and letting our nurse come see them, who is then trained on all those things. And as Eric has said, when do you contact the investigator. So we really build our processes to be very investigator-site centric. We have contact methods and escalation pathways that are customized to that investigator site. So that way, we follow their procedures, who to contact, for what knowing that, again, we are a tool to help them reach the patient and the patient home and they stay -- they keep that connectivity when we're doing the trials. Kelly, do you have anything to add to that?

Yes. Just to emphasize what you're talking about is communication and trust, right? So the key components are really keeping in mind how we make our communication partnership clear and really site and patient-centric, we talk about it a lot. And sometimes patient-centric doesn't feel like it's site-centric and sometimes site-centric doesn't feel like it's patient-centric. But it's really trying to keep in mind how each of those decentralized components that are enabled for the study makes sense for the study, makes sense for the sites, makes sense for the patients and try to lead together almost a journey that helps everyone feel supported, everyone aware in execution. And so how are we going to be successful, it's really about trying to maintain that open dialogue, having a lot of communication, so everyone understands what's going on, because it's really complex and I think recognizing the complexity of these studies is important to understand how you spend time planning, talking, establishing those strong relationships that really enable execution.

And with that, of course, as the whole process is becoming more digitized, we need to prevent the sites from becoming more tech support, because that was also one of the questions we get a lot. What about if the participants call the sites and they have the questions, how do the -- how does the site response? How do they deal with participants as well as site staff sometimes not being familiar with all the systems that come with that? How do we prevent the site from becoming tech support. Kelly?

Yes, Eric, I'll answer that question. So how does the site become tech support. I think there's an inevitable relationship, and because of the trust that patients have with their sites and their coordinators, but it's inevitable they're going to ask the coordinator first around this is not working, can you help me figure it out. So I think the idea is to minimize that and if tech support is needed, right, that it's gone to the right person. . But I -- the idea of tech support is something I hear about a lot. Sites give us that feedback saying, "Oh, I feel like I'm on the phone all the time and patients are calling with this technical thing." It's kind of starts at the very beginning, like how do you pick the different things, the different technologies or systems that makes sense and try to keep in mind the patient journey at the end of the day that the patient is the last one that's going to be interacting with all the stuff, and it's what it's made for. So trying to be very mindful in terms of setting up the workflows of the technologies of the processes, anticipating questions, trying to spend a lot of time at the front end. So your patients and your sites are not really encountering the minimum number of issues. So I -- the intention of the site is not to be tech support. And at IQVIA, one offering that we have is really -- it's called the DCT study assistant. And what that person does is help navigate it a bit for the site. So sometimes, if there's a question that they have, they don't really even understand I'm having this problem. They can reach out to their DCT study assistant and really talk through the problem and help even figure out what the right tech support line is to call. So it's about partnering and hopefully, spending time at the beginning, so we have less issues towards the end. Unfortunately, I do think because of that trust relationship that sites are never going to get around being the first person that I call to some extent. But I think as we continue down the path, the tech support needs will become less and less, especially if we set up from the beginning kind of a integrated support strategy.

Thank you, Kelly. So that means we are adding roles to supporting the sites, again, enabling the sites to be successful and preventing them from ending up being tech support to their participants, so that they can focus on actually conducting the trial and then paying attention to the participants, making sure that they have their attention. That means we're adding roles to the business model. We're adding people to support the investigators and the sites in conducting that trial. So what is the impact of adding those roles to the site business model? Can you comment on that, too, Kelly?

Yes. So I'm hopeful that the impact of adding these roles, the site business model helps enable kind of this new environment that we're in. The -- but the -- what it does is bring complexity, right? It brings a level of complexity to execution. And so when we think about kind of the greatest impact, but I think that sites feel is really just -- it become -- you're encountering more people for different things. And so it's really important to understand each of those different touch points that you have. We talk a lot about optionality. Patients can come to the site, they can come -- they can have a visit at home with their nurse. So it's understanding kind of what a study will feel like from the beginning, and we talk about like patient mapping or journey mapping, each of those different complexities for execution. Kat, do you have any thoughts around the impact of when RNPS as added to a site business level?

Yes. That is a great lead-in to what ultimately, our services are about options and choices. Yes, there are complexities that come with all these roles and the different parts. But the parts are to give patients the choice and investigators the choice. It is to make it easier. So although it sounds like there's more systems and more complexities and more things to range, we take those complexities behind the scenes, work on all the logistics that enable the nurse to go to the patient home to reach the patient. So although it sounds like a lot going on, that is what we're here for. We are here to support the site and to help with anything. Yes, the patient might call the site first for that the tech support, for instance, but they also have the nurse coming to their home. So if they have any questions, and they have anything that they want to direct, they can have that person to kind of walk through and we can train our nurses to make sure that they understand every step and then assist in that way. When it comes to any kind of study related question specific to the protocol, we do defer back to the site. So they're not interfering with the information that the situs providing. They are there to collect the study data, and we support the site in helping reach their patients. And again, that is -- I know we've said it before, but ultimately, these roles in the business model, that's what the end goal is.

Wonderful. Thank you, Kat. And I think with that, we're also continuously seeing that this whole model is optimized per trial and to customize the trial and optimizing the sites to set them up to be successful with that. So there's different options that can be added depending upon the trial needs, if I understand that correctly.

Yes, that's correct. So adding anything, too, is to help the sites ultimately. And we want to empower the sites to have these choices. We don't want to force choices onto the sites. That's not what this is about. It is truly to give choice. And a lot of patients, just like in a lot of our day-to-day situations, might not voice or vocalize the complexities and the burden that some of these roles add to them. So we try to predict it. We try to work with them, and we really try to make it as easy as we can, having the sites -- or I'm sorry, having the nurses, call the patient directly building that trust directly. That is the person that's showing up at their door. It is the person that's coming to them directly into their home. So having that conversation ahead of time and just kind of letting the patient know, this is what we're going to be doing. And as much of the information as we can, while keeping it simple, that's the only contact that the patient has for us in terms of scheduling. So they just have to pick up the phone. All these other roles and things and services that we just discussed, at the end, the patient has to do very minimal, and we try to do that same with the site where we carried the burden for them. We want to be that bridge and help. Kelly, is there anything on your side that you wanted to add that?

Yes. Just that as you speak about I think about our partnership, right, and the intention is to help sites take what works best for them. So it's not just about what works best for the patients, it's also about asking the sites having that open dialogue with them. Would you -- does this work for you? Does this not work for you? How can we partner or what makes sense? And just want to reinforce that optionality, and we're talking about a lot, but that it's intended to be both for sites and patients in this new model.

Thank you so much, Kat and Kelly. And you both underlined the importance of building trust and ensuring that we have a trust relationship between the partnerships that were so clearly identifying here. That concludes the questions that we regularly get from the business. But I'm sure there are some questions here as well from the audience here today. So going back to you, Andy.