An interview with Phillip Stanford, Senior Director, Applications & PMO at EmVenio Research, a PCM Trials Company.
Q: Can you tell us more about EmVenio Research’s business model and how it’s expanding research to underrepresented communities?
A: EmVenio Research provides a scalable network of clinical trial sites. We are strategically located in clinical trial naïve communities to effectively reach and engage participants who might otherwise go unnoticed or be underrepresented in clinical trials, promoting greater diversity. By leveraging a combination of community sites and standing up research in existing community hospitals, EmVenio is expanding the reach of the traditional site network ecosystem. With sites more conveniently located to patients, travel, schedule, and daily life challenges are minimized – resulting in improved willingness to participate and remain on studies.
Our goal is to ensure that individuals in underrepresented communities have access to educational resources about the importance of participating in clinical studies and inform them about the opportunities available to them. In doing so, we aim to engage with patients and empower them to take control of their health, including considering clinical research as a care option (CRAACO).
Q: How does EmVenio prioritize diversity and inclusivity in clinical trials?
A: Expanding the reach of clinical trials and establishing connections with previously untapped, underrepresented communities are the building blocks EmVenio has used to welcome a potentially underrepresented patient population and promote greater diversity within clinical trials. Achieving this goal involves engaging with communities to expand patient engagement while providing patient-centric visit options, such as virtual, in their homes, at their workplaces, or conveniently located sites within their own communities.
Our model has a significant impact on patients by removing barriers to participation in clinical trials. We bring the trial to diverse patients, making it more accessible to them. This increases the chances of successful outcomes and ensures that the data collected is more representative of the entire population.
Q: Collaboration is essential in advancing diversity and inclusivity in research. How does EmVenio collaborate with other stakeholders to achieve its goals?
A: EmVenio actively engages with a diverse range of local stakeholders to better understand the community, address their needs, and also to have brainstorming sessions on how to serve the community and improve their health. These stakeholders range from local government officials and healthcare organizations to universities, religious organizations, recreational centers like YMCAs, senior care facilities, neighborhood associations, and food assistance programs. By working hand in hand with these key partners, we aim to create a lasting impact and promote a healthier, more connected community.
Q: What are some of the biggest challenges EmVenio is currently facing in reaching and engaging underrepresented communities?
A: As we are often entering trial naïve locations, communication and trust become very important. Our communication needs to focus on the importance and benefits of participating in clinical trials, informing about the trials available, and, if they are interested in participating, making sure they understand the expectations in terms of timelines, visit activities, and the full implications of trial participation.
Of course, building trust goes beyond just communication. In any location, EmVenio aims to become a long-term and trusted member of the community. We hire local site staff from within the community and engage with local physicians, nurse practitioners, and pharmacists who provide care to patients who may not have a primary care physician. We work to get the community engaged with our clinicians outside of the clinic as well, as we involve ourselves in community activities such as food drives, community events, health fairs, movie nights.
Q: Technology plays a crucial role in addressing the barriers to participation in clinical trials. EmVenio has adopted RealTime-SOMS, a comprehensive clinical suite of software to help expand access to clinical trials. Could you share some examples of how implementing RealTime-SOMS helps EmVenio address those challenges?
A: Technology definitely plays a vital role in breaking down barriers to clinical trial participation, and EmVenio leverages RealTime to do just that.
To start, RealTime streamlines outreach and enrollment for us. Imagine this: during our free health screenings in the community, we can easily register participants using iPads equipped with the RealTime CTMS app. This fosters a connection and builds trust, allowing us to have open conversations about the importance of clinical trial participation and the need for diverse representation.
Furthermore, RealTime facilitates efficient scheduling, follow-up, and overall conduct of the screenings. This translates to a smoother and more accessible experience for participants. It’s a win-win: we effectively engage our communities and they have a positive experience that might pave the way for future clinical trial involvement.
Q: How do RealTime’s Mobile App and Engage! platform facilitate the recruitment, engagement and retention of participants from underrepresented communities?
A: The Mobile App is like a personalized portal for participants. They can access their upcoming appointments, track their stipends (a great way to incentivize participation!), and even complete electronic surveys (ePROs) directly from their phones. This convenience eliminates the hassle of paperwork and missed appointments. Plus, they can easily review their signed consent forms and contact the study site if any questions arise. The platform takes things a step further by offering virtual visits with clinicians. This is a game-changer for busy individuals, virtual trials, or those with transportation limitations. Imagine participating in a crucial study from the comfort of your own home!
The beauty lies in the seamless integration though. Participants can use these tools across all EmVenio studies they’re involved in. It’s like having a dedicated research assistant in your pocket, keeping you informed and connected throughout the process. We’re confident that this technology will help us reach and include a broader range of participants in research.
Q: RealTime-SOMS offers various features and capabilities. Which aspects of the system are you most excited about leveraging to enhance EmVenio’s efforts?
A: RealTime has been transformative for us at EmVenio. It’s like having an all-in-one toolbox for managing clinical trials. Think about it – participant recruitment, scheduling visits, eISF, sending text reminders, electronic source capture – RealTime handles it all. Even features like remote monitoring for eSource and eISF, managing stipends, eConsent forms, and even virtual visits are seamlessly integrated.
The advantage is in its comprehensive nature. Standardizing on this platform streamlines our entire clinical workflow. From a trial delivery perspective, it makes everything more efficient and organized. We’re excited about the positive impact it will have on both our research operations and the participant experience.
Q: Can you elaborate on some specific features or functionalities within RealTime-SOMS that are particularly beneficial for EmVenio’s priorities?
A: Let’s take a specific scenario. Imagine a fast-enrolling study happening in a Community Research Site at a church in California. It’s not uncommon to have a nurse a couple of states over in Texas schedule participant visits for that site. With RealTime, that appointment is instantly visible to everyone who needs it: the clinicians on-site, the virtual Clinical Research Coordinator in Ohio, the Site Director in Georgia, and even the VP of Site Operations all the way in the UK!
That’s hugely beneficial for EmVenio – it bridges the gap across four states, four time zones, and two countries, all within one unified system. This not only streamlines communication and scheduling for decentralized trials but also empowers EmVenio to operate as a truly decentralized business, at scale.
And it goes beyond just convenience, RealTime also allows our regulatory team to maintain strict oversight and compliance of electronic Investigator Site Files (eISFs) for trials happening hundreds of miles away. This ensures regulatory adherence no matter the location.
Q: Integration and ease of use are often crucial factors in selecting software solutions. How has the implementation process been for RealTime-SOMS at EmVenio, and what benefits have you observed so far?
A: Integration and ease of use were top priorities when choosing a clinical trial management platform. Thankfully, implementing RealTime has been a smooth process.
The team at RealTime was fantastic throughout the whole setup. They have a proven track record in the industry, which gave us peace of mind. The implementation itself was quick and efficient, and they provided excellent training materials and ongoing support for our team. This made getting everyone up to speed a lot easier.
When it comes to the interface, our clinicians, who have extensive healthcare experience operating in EMRs and EHRs, have provided feedback that RealTime is intuitive and easy to navigate, which saves us a ton of time and minimizes errors. Plus, the back end is highly configurable, so we can tailor the system to fit our specific workflows.
Overall, our partnership with RealTime has been fantastic. Their strong account management ensures we get the support we need, and it feels like a true collaboration. RealTime has become a key part of our success in streamlining clinical trials and delivering high-quality research.
Q: In what ways do you anticipate RealTime contributing to improved efficiency and effectiveness in EmVenio’s clinical trials operations?
A: This is a big focus for EmVenio, and RealTime is critical in that regard.
Think of it this way: traditionally, you might need to juggle multiple, separate systems for different parts of a clinical trial. Scheduling in one, recruitment in another, and maybe a whole other platform for electronic documents. RealTime eliminates that juggling act.
It’s a single, unified ecosystem for managing everything – scheduling appointments, recruiting participants, managing our call center, tracking participant data, handling electronic documents, and so much more. It’s all there, under one roof.
This translates to huge gains in efficiency. No more jumping between systems or wasting time trying to find information. Everything is centralized and readily accessible. This allows our team to focus on what matters most – running high-quality trials and delivering a positive experience for participants.
Beyond efficiency, RealTime also promotes effectiveness. Having a single source of truth for all trial data minimizes errors and ensures everyone is on the same page. This not only improves data quality but also allows for better decision-making throughout the trial process.
Q: Can you discuss any success stories or notable achievements resulting from EmVenio’s business model and technology-driven approach to clinical research?
A: A client approached EmVenio with a usability study – tight deadlines, specific requirements, and no wiggle room. They needed 50 participants with a very specific profile, and the clock was ticking. Traditionally, this kind of targeted recruitment can be a major hurdle.
But that’s where EmVenio shines. Thanks to our established community engagement efforts and a robust technology platform, we were able to hit the ground running. With our ever-growing database of potential participants, and RealTime’s subject matching capability, we can sift through thousands of profiles to find the perfect candidates quickly and efficiently.
Within just two weeks, we leveraged RealTime to analyze over 4,000 potential participants in our Atlanta database. Our team then made over 800 calls using RealTime’s built-in interview scripts and contact tracking features to streamline the process. The result? We not only met the target of 50 participants, but we exceeded it by seven! Even better, we achieved near-perfect compliance with the client’s specific participant requirements.
Q: What impact is EmVenio having on increasing the accessibility and inclusivity of clinical trials?
A: By bringing trials to the patients, our studies have resulted in an average of 44.7% diverse patient enrollment, compared to an industry average of 25% according to the FDA in 2020. Our patient-centric solutions have also led to increased patient retention, with 98.5% of study enrollment targets achieved.
Q: Do you have any advice for sites considering the transition from paper-based processes to electronic solutions?
A: Start with the “why.” Think about your goals. Is it streamlining workflows? Improving data accuracy? Once you have a clear vision of what you want to achieve, it’s easier to find the right technology and overall solution.
Embrace change management. Let’s be honest, not everyone loves change. Be upfront with your team and address any concerns. Consider a phased approach, rolling out the new system step-by-step to allow for comfortable adoption. Offer training and support throughout the process.
Think beyond efficiency. Technology isn’t just about saving time (although that’s a great perk!). It can also open doors to new opportunities. Look for a system that can evolve with your needs and support future growth.
Embrace collaboration. Modern clinical trial software is often cloud-based, which means you’re joining a global community. This shared experience is a goldmine! You can benefit from the combined feedback and best practices of countless other sites using the same system.
Ultimately, going paperless isn’t just about replacing paper with screens – it’s about embracing a new era of efficiency, collaboration, and innovation.
Q: Looking ahead, what are EmVenio’s plans for further expanding its reach and impact in underrepresented communities, and how do you envision technology continuing to play a pivotal role in achieving these objectives?
A: EmVenio’s future involves a “Swiss army knife” approach to trials. We’ll offer flexible options like virtual participation, convenient community sites, comfortable brick-and-mortar sites, and even home visits! One of the keys to this flexibility is the RealTime platform. It seamlessly connects everyone involved, allowing us to meet people wherever they are and bring clinical trials to their doorstep. This approach, powered by technology, ensures everyone has a chance to participate in groundbreaking research.
