Using trial participant diversity as its roadmap, one site network has taken decentralization to its farthest limit by operating solely as a fleet of “sites on wheels” to serve communities that have little to no access to clinical trials.

EmVenio Research began its travels in August 2022 when it spun off from Matrix Medical Network, a home- and mobile-based healthcare service provider based in Scottsdale, Ariz., embarking on a quest to bring trials to underrepresented populations. EmVenio now has site vehicles currently stationed in locations across the U.S., including Albuquerque, Atlanta, Chicago, Fort Worth, Little Rock, Oklahoma City, and Orlando, among others.

Like so many other site networks did during the pandemic, EmVenio’s predecessor, Matrix Clinical Trials, began employing remote methodologies to facilitate trial participation amidst widespread shutdowns and social distancing.

Matrix conducted COVID vaccine and therapy trials using a fleet of RVs as mobile trial sites, strategically gathering participants by parking the vehicles long-term in locations with easy access for the community, such as churches and shopping centers.

The experience was so successful that Matrix Clinical opted to spin off as its own business, changing its name to EmVenio Research, specifically to pursue trial diversity as its core mission.

According to President Thad Wolfram, EmVenio was struck by the huge potential of mobile sites to make trial participation easier by adjusting to patients’ schedules, travel capabilities and daily life obligations.

“Our experiences during the pandemic working with underserved communities compelled us to return with the long-term mission to provide reliable access to research and health education, while creating local job opportunities for principal investigators (PI), nurses and clinical coordinators,” Wolfram told CenterWatch Weekly. “EmVenio’s model to expand patient reach has resulted in 40 percent participation among minority populations.”

Potential trial participants have responded well to the mobile site approach, showing curiosity and engagement in large part due to the training of EmVenio’s onsite team members, who are well-versed in being welcoming and conscious of diverse backgrounds.

EmVenio is currently in the process of activating 10 mobile sites across the U.S. in rural, suburban and urban areas that will all begin running a trial on treating COVID in healthy adults, as well as additional trials to meet specific community needs. Each vehicle will be staffed with a clinical research coordinator, nurse practitioner, a registered nurse and a fleet coordinator who manages the mobile site itself, with possibly more staff added depending on demand. These sites are also served by the company’s PI network, which is made up of licensed physicians that practice in the specific geographic areas covered by the mobile sites.

With the obvious exception of mobility, these sites on wheels aren’t that different from a traditional brick-and-mortar clinic; EmVenio’s largest RV has a waiting area, reception desk, bathroom, pharmacy and three exam rooms. Each mobile site is prequalified, initiated and activated in the same manner as a traditional facility, with the same onsite qualification and study initiation visits.

“While our model is novel to many, running research sites is a well-trodden path,” Wolfram said. “Continuous industry and customer education on our vast similarities to the traditional research site is important and enables customers to approach our model similarly to their standard site startup, activation and risk-based monitoring programs,” he said.

Sites venturing into the mobile site approach should employ the same strategies for staffing and management that they use at their permanent location(s), Wolfram recommends. But those interested in the mobile site approach should be aware: Long-term success has required significant investment and commitment.

“Understand investment in underserved communities is a long-term investment,” he said. “That community trust takes time to build and it is about what you offer the community, not what you seek to gain.”

In deciding where to deploy a mobile site to meet a trial’s participant needs, EmVenio runs its own protocol feasibility assessment across its network to formulate strategy on patient education, engagement and attraction, in addition to working with local community patient referral partners, local activists and an internal central marketing team. The company also considers locations that have high-risk populations, greater diversity and underserved healthcare needs.

Upon selecting a location, Wolfram says EmVenio usually makes commitments to be involved in the community and deliver several trials long-term. If interest and enrollment aren’t panning out at an initial spot, the site can simply be repositioned elsewhere within the same community.

Running a fleet of mobile sites hasn’t been without its challenges. One of the greatest hurdles has been IRB guidelines, Wolfram says, particularly in aligning with sponsors and CROs on how to interpret them and apply them to EmVenio’s model.

Fulfilling EmVenio’s mission to reduce its use of fossil fuel was also a struggle at first, with sustainable energy an uncommon resource. The company has shifted its approach to invest in local community infrastructure and install upgraded electrical charging equipment at mobile site locations, and it’s considering adding fully electric vehicles to its fleet to be even greener.

Localization — learning and adapting to a community’s local language, culture and traditions — is also one of the most important keys to success, and EmVenio’s strategy on this differs from location to location. “This is really critical to building trust and finding success in engaging with any given community,” he says. “There is no one-size-fits-all approach.”

And with EmVenio finding that the cost to maintain all these vehicles varies significantly based on a number of factors, they are actively working on a sustainability plan that will enable them to reduce costs and environmental impact over time.

Last Monday, EmVenio announced that it had activated its latest mobile site, opening it in Orlando’s Waterford Lakes Town Center, an open-air shopping center that offers restaurants, retail shopping and entertainment as well as a nearly three-mile-long fitness route. According to Wolfram, the site will look to serve Orlando’s Hispanic and Asian patients, which account for 23 percent and 15 percent of the city’s population, respectively.