At the height of COVID-19 vaccine research, everyone was on board: site staff, sponsors, CROs, vendors, and most of all, patients, unified for a singular focus. Our industry, and the world, saw incredible speed and results. Now that the world has progressed and individual factors are no longer aligned, the goal of vaccine research stays the same. Because of this, the next year will see the continued trend of high expectations, with traditional resource constraints in place, bringing the need to focus on enhancing efficiency at sites. 

Sites can maximize resources by leaning into the lessons learned through the pandemic. One practice that enabled the speed of pandemic vaccine research is the clear delegation of duties at sites. Recruitment and retention needs are not mutually exclusive, but sites should clearly assign the tasks associated across the patient journey to team members. These specific tasks require not just delegation, but dedication from team members. When the team knows who carries each responsibility, members can focus on their specific tasks and work efficiently. The concept sounds simple, but putting it into a repeatable practice takes effort and specialization. 

The next year of vaccine development will continue to focus on respiratory diseases, including new variants of influenza and COVID-19. The year will also see a growing focus on new and emerging diseases such as dengue fever and Zika, and advances in bacterial and viral indications, including meningococcal, hepatitis, and chicken pox. Each specific indication will require sites to focus on healthy but at-risk populations. Sites must continue engaging with the target population to bring awareness of these vaccine areas and ensure the efficacy endpoints can be achieved. 

The industry desires efficiency. Sites can expect sponsors to work on bringing efficiencies through new and consolidated technology. From a site’s perspective, some will work, some will not, and the ongoing trend of technical issues will persist. Still, sites should work openly through the challenges and approach changing technologies with the basics of the scientific method. There is a hypothesis that changing technology will benefit research. To continue to advance as an industry, we all need to go through the methodology to determine if the results support the hypothesis.  

Vaccine research in 2024 will continue to press forward, and sites will continue to find ways to be more efficient in their processes. The pandemic proved what is achievable, and efficiencies were born from the process. With the mindset of continuous process improvement, patients will be the beneficiaries of the work to come. 

Related Insights:

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About this episode:

In episode two of WCG Talks Trials, we are joined by two WCG experts to discuss overcoming common enrollment challenges and how DE&I, technology, and protocol design factor into enrollment success.

Listen in as we delve into the critical topic of common enrollment barriers in clinical trials, how to improve enrollment by focusing on DE&I efforts, the importance of site-centric and patient-centric technologies, and how thoughtful protocol design plays a significant role in enrollment success.

Speakers:

• Jamie Harper, MHA, CCRP – Vice President, Site Solutions & Engagement at WCG
• Tyler Bye – Director, Site Solutions & Product Strategy at WCG

Episode Transcript

Dawn Sauro:

Hi everyone. I’m Dawn Sauro and I’m thrilled to be your host for today’s episode on the topic of overcoming common enrollment challenges in clinical trials. Before we dive in, let me remind you to subscribe to our podcast and follow us on your favorite listening platforms like Apple Podcasts and Spotify, so you never miss an episode of WCG Talks Trials.

We are joined today by two WCG experts, Jamie Harper and Tyler Bye. Thank you both so much for joining us today. Before we get started on today’s interesting topic, we would like to start all of our podcasts off by getting to know our guests a little bit more. My question for both of you today is, how and why did you come to join the clinical research industry? Let’s start first with Jamie.

Jamie Harper:

Hi. Thanks Dawn. Thanks for having me here today. My story really begins in the lab as a clinical laboratory scientist and in the laboratory I was really focused on the hematology department working very closely with our St. Jude Clinic and Children’s Hospital. So being on the diagnostic side of leukemia and other blood disorders, made me really think, how can I help them feel better? How can I prevent some of these things from happening?

And that led me down the clinical research world where I became a clinical research coordinator for our local oncology practice. And at that private community oncology practice, I worked my way up to the director of clinical research where I was there for about 13 years. So bringing that site experience, WCG has been very helpful. And my pathway was really convoluted. It wasn’t a direct lab to clinical research path, but it really did begin in that laboratory space.

Dawn Sauro:

Thanks, Jamie. Impressive experience. Now over to Tyler.

Tyler Bye:

Thanks Dawn. And I echo Jamie sentiment. Thank you for having us here today. So my background really in clinical research, it’s all I’ve ever known on the professional side. Going into school and into college, I was one of the many people who go in knowing they want to go into the healthcare field, but not really knowing where.

I took the pre-med track, did all of the bio and all the chem courses, realized that being in practice wasn’t what I wanted to do. But had the great opportunity right after graduating of becoming a clinical research coordinator at the University of Wisconsin Madison Cancer Center. Being there part of the radiation oncology team, running trials, working with patients day in and day out, and really getting to learn about an industry that it’s the biggest small industry out there.

And I’ve been able to grow in the industry, grow my career, working both on the site and then on the sponsor side. And now here with WCG for coming up on 10 years, I’ve been sitting in this really unique position working with all sorts of clinical research, all sorts of sponsors, all sorts of indications, and really understanding how we can help accelerate the efforts of recruitment and ultimately getting therapies to patients faster.

Dawn Sauro:

That’s great. Awesome experience as well. And really interesting to hear you both have interest and passion in oncology, which is an area that interests me a lot as well.

So now we can dive into our topic for today’s episode, overcoming common enrollment challenges in clinical trials. Can you discuss the main obstacles organizations find and hard to enroll studies?

Tyler Bye:

I’ll jump in on this one. So I think we’re in the unique position. Jamie and I both get to speak with sponsors and sites all day out every day to understand what they’re going through and understanding that enrollment. Well, it seems simple to have somebody join a study. There’s a lot that goes into it. There’s a lot of work that happens.

And I think one of the pieces where we see this day in and day out is competing studies, competing trials that are out there. We know that there are a lot of different organizations, there are a lot of different interests and a lot of different reasons why certain indications have a lot of different studies that are competing. We know that a patient is being offered multiple studies, but they have to choose one. And what we commonly hear from sponsors is that why is it their study not being chosen? Why is their study not enrolling that patient? Why are they potentially looking at another one?

And as we hear about that, there’s a multitude of reasons why, but it really comes down to understanding how do you overcome those pieces as well. I know we’re going to talk about a lot of that. But I think the idea that the clinical trial landscape is always growing. That piece of itself is definitely a challenge for a lot of the industry.

Jamie Harper:

And I think it’s a common misconception that one study site is just doing one trial and that indication, and that’s just not the case. And it often comes down to a question of, if you have multiple studies in the same indication or the same area, the question becomes, do I choose a study that’s easy to conduct but doesn’t pay as much, or do I go with the sponsored study that is a little bit more difficult and more time-consuming, but they pay more? So what’s the priority? Is it the bandwidth and the time and the patient need or is it the financial need in order to keep the doors open at the institution?

So I think that’s a very common push and pull that we see at the sites. And I also think with that, the recruitment plan is very important. And one of the issues that I saw from my site was, at the feasibility portion we would have a recruitment plan in place in order to really determine if we can even conduct this study or not. But then the SIV and site activation may take 6, 7, 8 months, and by that time, the recruitment plan is now out of date.

And the time that had been allocated to do the recruitment plan in the first place is now taken up by other studies that are coming through. So being able to reinvest that time that was spent in the recruitment plan in the first place is no longer available. So that study tends to get pushed to the side. So those recruitment plan development to activation, that timeline is very important.

Dawn Sauro:

I know one of the things people talk a lot about is referrals. And you touched on something that triggered this in my mind, Jamie, is that a lot of the times physicians don’t want to lose the patients from their practice for them to be referred out to a research program at another facility. So how would you suggest that folks overcome that challenge and make sure that the patients that could benefit from the trials are perhaps referred away, but maybe that practice still is able to stay involved?

Jamie Harper:

I think part of the reason for that is lack of information. The physician who’s referring needs the information of what the study entails and reassurance that the participant will come to that research site for the research conducted visits. They’re not usurping that patient over into their patient population.

So I think giving the information about what the clinical trial really entails and really developing those relationships and partnerships and collaborations to build that trust between the physicians is important as well.

Tyler Bye:

And if I can add onto that, I think something, when you talk about referral physician networking, it’s one thing to present the study to another physician or another doctor and say, “Hey, there’s this study available.” But that oftentimes can be forgotten. That can be forgotten in just the daily commotion of patient care.

So in some cases it does take the investigator site or that coordinator multiple times, multiple attempts to, Jamie, as she said, build that trust, build that relationship. It’s an ongoing effort. It’s not just a one time, we’re going to make you aware of this. It is an ongoing check and it’s building that relationship because I mean, that’s really what networking is at the end of the day.

Dawn Sauro:

So shifting gears a little bit and thinking about recruiting and diverse populations, and it’s along the same lines of what we’re looking for because sponsors are looking for more diverse populations, so that’s driving them to put the pressure on the sites to find that. What do you think some of the best practices are for recruiting those diverse populations that our sponsors are looking for?

Tyler Bye:

So this is a great topic in the industry. There’s a few really key areas I think that we can think about for diverse population recruiting or reaching an underserved population. I would break it down to three main areas. So you have the protocol development, you have the site selection, and then you also have just the recruitment outreach efforts and how you’re actually reaching that audience.

I think you really have to look at each of those individually to understand, they all build off of each other, but when you need to bring research to the real world population, starting with the protocol development and how it’s written to identify and recruit individuals, is a key piece. We all know that in clinical research, the protocol defines who we can recruit, who we can bring into the study.

So if the study doesn’t have parameters around it of saying we need to represent a real world population, right there you’re already presented with a new challenge just from the protocol development.

Jamie Harper:

I agree that protocol development is critically important, and having voices that represent the community as part of that protocol development is going to be key. Every population is different. They have different recruitment pathways, they have different levels of trust within the community, so it’s not a one size fits all. So having that participant voice, having that community voice from the very beginning will help mitigate and prevent any issues in recruitment down the line.

Tyler Bye:

Yeah. And as we’re thinking then about the trust piece, I’ll call on a phrase that Steve Smith, the WCG says, “The trust bears in the community.” This is a huge issue I think in research where there needs to be new investigators. We know that the investigator pool is small and there’s always new ones coming into research, but they need to have that connection with their community.

And if we can have a trust bear become an investigator and start that clinical research process with that population already around them, that’s definitely a way that we can increase the ability to bring research to the populations that really need it.

Dawn Sauro:

Great. We’ve recently done a number of site surveys and gathered feedback at WCG, and some of the biggest pain points that we’ve heard from the sites are about staffing challenges, which I think is something that we’ve been talking about for a number of years now since the pandemic started, and also the increasing level of complexity that’s brought to the sites with all the various technologies. I think we’re all trying to help sites with technology, but we’re hearing from the sites that technology and it is sometimes becoming a challenge for them because everybody does it a little bit different. So wondering your thoughts on those two topics.

Jamie Harper:

I know what the shrinking number of investigators and the increasing number of clinical trials, staffing and bandwidth is a consistent topic. And I think one of the things that I think we need to understand is that clinical research is time-consuming. And what I think some sponsors may not realize is that there’s a lot that happens. The in-between study visits, they’re not points in time. It is a continuous process. It is a continuous pathway in order to have that participant from recruitment identification all the way through to study completion.

So it’s these little nuances that each site may have in order to continue that pull through from the patient that may not get recognized in the study budget or just in the complexity of what a trial entails at the site. And that really does contribute to the staffing issues at sites or those little nuanced in-between visits, time-consuming tests that are required.

In technology I think we can… It’s really twofold. It’s technology for the research site in being able to navigate all the different technologies and portals and systems that are used for each individual clinical trial. But then also on the patient side, the patients also have to deal with that as well, and looking at smart technology and smartphones and are they even able to have internet access? Do they have the high speed internet that’s required to run this device? Are they knowledgeable about the technology? So it really is twofold on the research site and the participants involved in those clinical trials that require that high technology. And with high technology also comes high touch for those reasons.

Tyler Bye:

Yeah. I live in the product world, so the technology piece there is really true to my heart and what we’re doing. I think we live in an evolving industry. I mean, this is what clinical research has done over the years. That’s the goal is to evolve and change. With that has come a lot of new tech. A lot of new players in the industry.

One of the things I think that makes things more complex is sometimes it feels like it’s tech for the sake of tech. That doesn’t really solve problems. At the end of the day, I like to try to bring everything and research back to the whole keep it simple process. We are identifying someone, we’re bringing them to the study. We need to get them treated. We need to collect the information.

If the technologies at the site and for the patient aren’t actually meeting those goals, then we’ve overlooked some of the key pieces that actually are needed for research to continue. But yeah, as Jamie said, with technology, it’s a high touch area. Because you think of the concept of an e-diary of somebody filling out questionnaires during the course of enrollment and through the study. If you miss one of those, you might miss that notification on your phone or on your device. It may take a phone call from that coordinator to help you follow up with that. And that’s where I think with technology, there still needs to be that human element, that piece that actually brings everything back together together.

And as you’re thinking about the technology that’s going on, it needs to embolden the relationship between the site and the patient, because that patient and the site, it’s a reciprocal relationship where they’re both putting time and effort into this. It needs to be well understood on both parties, what their obligations are, what they need to do, and what really is defined as success for participation in the study.

Dawn Sauro:

Yeah. I think with the tech topic, we definitely skirted the issue of patient centricity a little bit too. So maybe we can just dive into that a little bit more. It’s a common news buzzword in the industry, but we talk on the tech piece of it but, what other advice would you give to sponsors to run better trials and to design better protocols that are more patient friendly, let’s say?

Jamie Harper:

I think Tyler really hit on it in a previous question on that protocol development and using a patient advisory board for those protocols. Not only will that contribute to the patient voice, the community voice, it will help the protocol be more friendly for those who are willing to participate in a clinical trial.

But I also think we need to think about the difficulty on the physicians, and they have the same stress as the research site and the patients do. So I think it is twofold, again, where we need to focus on the patients, make sure it’s easy for the patients. We’re not adding a new burden by high tech, high visits. Things that may not be necessary. And also the physician as well, and trying to meet all of these stringent FDA requirements, the regulations and everything they have to go through in order to get the patient enrolled. So how do we make it easy for both parties to conduct clinical trials?

Tyler Bye:

If I can add on that, just being patient focused and participant focused, I think one of the key things that needs to happen, and it goes back to protocol design, it goes back to really the site interaction with a participant. Joining a study is a choice. I mean, that is a very much a choice on the participant and oftentimes on their family for them to join that study versus other healthcare options.

The study itself, that is an offer that’s being presented to the subject. It needs to align with their motivations. And I think keeping that in mind of what is that subject’s motivation for joining that study, for being part of that study, for staying in through the duration of that study, that needs to be kept top of mind at the site and even at the sponsor side through the protocol development and execution. If we’re not keeping in mind why that subject has joined the study, you lose sight of really what it means to have that individual and their family being part of that healthcare journey in clinical research.

Dawn Sauro:

Well, I think we’ll wrap it up here. Thank you so much to Jamie and Tyler for joining us today on this episode of WCG Talks Trials. And thank you to our listeners for tuning in. We hope you found this episode insightful and that you’ll join us for future episodes of WCG Talks Trials. Bye for now.

The post Breaking Down Enrollment Barriers: How DE&I, Technology, and Protocol Design Impact Enrollment Success appeared first on WCG.

The goal isn’t merely to enroll patients, it’s to successfully complete the study. To that end, we’re going to identify ways sponsors and CROs can help sites optimize enrollment capacity and improve overall study enrollment and retention.

A Flexible, Centralized Strategy

Begin with a centralized study enrollment strategy based on the protocol and targeted population. The centralized plan needs the agility to respond promptly to any site-specific issues and real-world complications.

Enrollment capacity involves all the resources that are needed to complete a trial, such as processes, team expertise, operational efficiency, and technological tools and, of course, time It takes just one flawed process, one obsolete technology, one understaffed area to stall enrollment.

Success requires having the right amount of the right resources in the right combination. Take chart review as an example. Seemingly straightforward, it nevertheless involves numerous elements which require careful attention. Consider:

• Record selection: How are records chosen? Is the EMR easily queried, enabling you to identify the right patient pool before reviewing individual records?
• Evaluation criteria: What are the assessment criteria? Are there elements that will call for physician discretion that shouldn’t be evaluated during chart review?
• Tracking: What are you using to track the chart review to avoid redundant work? Are you using a web portal, a spreadsheet, a sheet of paper or something else?
• Roles and responsibilities: Who conducts the review? Is it a full-time study coordinator or someone who can only dedicate a few minutes a day? Is there a consistent, repeatable process in place?
• Follow up: Once you have a pre-qualified subject, what happens next? Who takes that next action? Does the record get lost in a pile of others, or is there a system to reach out to potential participants?

Chart review is just one example. Most clinical trial processes have components that should be considered individually.

Beyond Inclusion/Exclusion Criteria: Participants as Individuals

Turning a patient into a participant involves much more than the inclusion/exclusion criteria. Understanding the real person behind the I/E criteria helps build vital relationships—relationships that support enrollment and retention. Being a study participant means the patient has volunteered their time and their body for the study. Will that person be willing to take part in a 24-month study? Are they willing to commit to regular visits?

It’s crucial to understand each participant’s motivations, not just at the beginning but throughout their journey through the study. What are their reasons for joining this study? What barriers might prevent them from participating or completing it?

By focusing on the unique needs and motivations of each participant, we can build trust and foster a more patient-centric study environment. This is especially true for unknown patients.

When we talk about a “known” patient, we’re talking about someone who already has a relationship with the site and/or the PI. There’s already a level of trust. But what about “unknown” patients—patients with no prior relationship? It’s important to understand them, build that trust to work with the clinical study site team, to motivate them not only to enroll, but also to stay in the study. It begins with that first encounter: That first impression – be it a phone call, a flyer, a website visit, an online ad – needs to be a positive one.

Diagnose the Problem, Then Act

The enrollment process will rarely go exactly as planned. That’s why it’s important to identify and address challenges early, tailoring interventions to each site’s needs and limitations

Begin by examining all existing processes. Pinpoint the bottlenecks. For example, if enrollment is lagging, the site may need additional support for recruitment and enrollment. In other cases, data entry and query resolution are falling behind, and the site needs support there.Providing data entry support, in turn, may create additional bandwidth to continue focusing on recruitment efforts.

Focus on implementing solutions that enhance the site’s capacity without compromising efficiency.

Here, it helps to think about the study lifecycle. Themore time you have, the more options you have. Efficiency tends to falter when timelines shorten. So, the more you can do in advance and plan and prepare, the better.

Ask yourself: Do the tools and resources we’re providing increase the site’s bandwidth, or do they add extra steps? You want to increase the site’s capacity, not its burden. For example, if a study requires a patient to be newly diagnosed, a retrospective chart review won’t prove very helpful.

Think about this: Are you truly enhancing the site’s capacity to enroll more patients? Or are you imposing additional processes that could slow enrollment and diminish the site’s interest in your study –or in ever working with you again?

Put it in Practice

Learning from patients and sites and sharing best practices among different sites can be valuable.

Study coordinator meetings provide the opportunity to elicit best practices that other sites can adopt. It’s also an opportunity to learn what isn’t working.

In trials involving multiple vendors, coordination and oversight are crucial. Aligning vendors’ efforts and ensuring a shared vision for recruitment success requires proactive management and collaboration.

Setting benchmarks and key performance indicators (KPIs) is essential for assessing recruitment success. However, use them as evaluation tools, not as penalties. Foster an environment where everyone feels safe to flag problems early, identify them and work towards a solution without fear of retribution. The process never stops: Evaluate. Plan. Deploy. Assess. Adjust. Repeat. (See figure 1.)

It bears repeating: Change is inevitable, and your plans will require adjustments. That’s why enhancing clinical trial enrollment requires a comprehensive and flexible approach that considers the site’s capacity, patient motivations, and ongoing adjustments based on real-world challenges.

When we all come together and take this approach of being flexible and adapting to change, we can solve most problems.

Your Enrollment Challenges. Our Expertise. Take charge of your study’s outcome.

Connect with our team of experts to discuss your studies and how we can quickly meet patient enrollment milestones.

The post To Optimize Enrollment, Stay Nimble and Listen to Sites and Patients appeared first on WCG.

Sites and sponsors must begin with one question: What makes sense for the participant?

One of the first things we can do to understand the participant is to build a participant profile. That requires insight into all five Ws:

• Who is volunteering to participate? Who else may be involved (e.g., family members, children, caregivers, etc.)? Will there be any long visits or overnight stays? Think about the ways being part of this study will interfere with the participant’s lives.

• Where is the study taking place?Is the location convenient for the participant? If not, how will they get there? People may travel hours each way when the site is a larger medical center. Is that practical for frequent visits? “Where” isn’t just about physical access: Where are these individuals relative to the site? Are we looking for participants already part of the site’s healthcare system? If not, is the site in network with their insurance? Will there be potential costs for the participants?

• When does the study begin, and how long will it last? Are there seasonal factors to consider? Do the study visits work with school and work schedules? Can they align with regular checkups?

• Why do they want to be in the study? For example,is it altruism? Monetary reward? Is it an opportunity to a receive novel treatment otherwise unavailable?

• What happens if the individual doesn’t enroll? Are there other treatment options? Will they have the opportunity to reconsider?

These factors will be different for each site, each study, and each participant, so this list is simply a starting point, not a blueprint.

The Participant Journey

Answering those questions informs the participant journey. That journey should move clearly from point A to point B to point C. Figure 1 illustrates this process. Without that pathway in place, it will be difficult to plan how you will recruit, enroll and retain study participants.

• Develop the participant profile: Build the profile based on the questions discussed above.Understand what motivates and what worries the participant. If we are able to tap into that, we can engage the participant not only during recruitment and enrollment, but throughout the entirety of the trial.

• Develop recruitment tactics that align with the profile. Decide how you will reach new participants. Will you go out into the community? Use vendor resources? Turn to social media or advertising? Determining your recruitment tactics depends on how you answer the five Ws above.

• Provide initial education and prescreening: It’s just as important for the study to be right for the participant as it is for the participant to be right for the study. Participants need to fully understand what’s involved. And yes, after they do, many may decide against moving forward with enrollment, but learning that as soon as possible is best for the individual and your study.

• Study consent and enrollment: Carefully explain the Informed Consent form (ICF). Never send the ICF to someone without thoroughly reviewing it with them in advance. An ICF can be scary, and you don’t want it to be the reason you lose a potential enrollee.

• Clinical care: Once you enroll the participant, the real work begins. From Adverse Event (AE) monitoring and data entry to follow-up care and the final study visit, it’s essential to ensure the participant journey continues smoothly and ends successfully.

All this comes back to tailoring efforts around what works for the potential participant, the specific study, and each site.

Finally, keep in mind that this process isn’t the one participants see. From their perspective, the journey is (or should be) much simpler, as illustrated in Figure 2.

Communication across stakeholders

Effective communication supports successful recruitment and retention: Everyone knows what they’re expected to do. Such transparency supports collaboration and creates accountability.

Newsletters, webinars and study coordinator meetings can keep sites, investigators and sponsors grounded and on the same page. Most important is having a centralized tracking platform that sites and sponsors can view such as WCG’s My Patient. Transparency and easily accessible information can reduce the back and forth among sites and sponsors to keep the focus on the participants.

To enhance communications with participants:

• Keep them apprised of updates, timeline adjustments, protocol amendments and other changes.
• Provide after-hours support. Stay in touch: For instance, making a brief reminder call the day before a visit could be the difference between someone showing up or missing the appointment.
• Give each participant a point of contact. This enhances communication and shows you care about the participant. Along those same lines, show appreciation. After all, they didn’t have to enroll. Taking the extra five minutes to send a thank you card, or text shows your gratitude and helps keep them engaged between visits.

A Proven Strategy

When we focus on the participant’s perspective, we improve recruitment and retention and increase the likelihood of a successful trial. But successfully implementing a participant-centered approach requires sites and sponsors to use and understand the resources and processes that support open communication with participants.

For example, WCG supported a vaccine study in an elderly population seen in Figure 3. During the development stage of the enrollment strategy, we focused on tailoring all content to be very specific to the participant population of the study, which included understanding what other possible comorbidities and health treatments the participants may likely be experiencing. The information provided to the participants was targeted, clear and easily digestible. But simply creating customized content was only the beginning. We knew that engaging in continuous communication throughout the participant journey was the key to success.

With keeping the participant as the central focus of our process, we were able to establish as a 98% conversion rate between appointment scheduled and first office visit attendance. Additionally, every participant who attended the first visit also consented into the study.

This isn’t just theory: We’ve guided hundreds of sites and sponsors, helping them implement a participant-centered approach that boosts recruitment, enrollment, and retention. If you’d like to learn more, fill out the form below to meet with our experts.

The post To Ensure Participant-Centered Recruitment, Ask the Right Questions appeared first on WCG.