Accel Clinical Services, a private equity-backed network of clinical trial sites dedicated to the expert delivery of treatment options to patients and providers, was selected to participate in the pivotal Phase 3 clinical trial sponsored by Moderna to test the safety and efficacy of their mRNA-based COVID-19 vaccine called mRNA-1273. The organization’s clinic in DeLand Florida, 35 miles north of Orlando, recently opened its doors to local Central Florida media for a tour to learn more about clinical trials and the forthcoming COVID-19 vaccine trial.
Recently, Central Florida’s FOX 35 Robert Guaderrama was granted an exclusive tour of Accel Clinical Services’ (Accel Research Sites) lab in DeLand, Florida. Actually, the second site in Central Florida can play an important role in contributing to a potential COVID-19 vaccine.
In the clinic tour, Dr. Bruce Rankin, a study investigator, commented to the local news reporter that the effort will “probably be historic in slowing down this pandemic” sharing a confidence in the Moderna mRNA-1273 vaccine the lab will soon be testing in the Phase 3 clinical trial. The doctor emphasized that the typical vaccine can take six to eight years from lab to market and that the pace of vaccine development during this COVID-19 pandemic occurred at unprecedented velocity: the Moderna vaccine started clinical trials just in March.
Vaccine Study Participants in Central Florida
This Central Florida lab seeks up to 2,500 participants that are employed in sectors and industries associated with “high risk” activities, e.g. close contract with the public—such as theme parks, which are prominent in these parts. But Dr. Rankin also commented to FOX 35: “We’re talking about the theme parks, teachers, people in the public transportation. We’re talking about first responders; we’re talking about people who work in big facilities, warehouses…” Of course, these workers are at higher risk to become exposed to SARS-CoV-2 and are important for the volunteer effort.
DeLand is right near Lake Mary, the new headquarters of Accel Clinical Services and is about 35 miles north of the Orlando central business district, hence the town of about 35,000 can be considered part of Greater Orlando area, which approaches 3 million residents. Vaccine study participants should reflect the local populations impacted by the disease as well as those at most risk. Hence the region’s workforce has a large pool of potential volunteers, not to mention an elderly population and sizeable minority population (Orlando city is 28% Hispanic and 25% African American).
Accel Clinical Services was founded over two decades ago and over time has developed not only a compelling network of physician/investigators but also has been able to work on refining the process for driving patient safety, quality and productivity in clinical research. Organizations such as Accel Clinical Services over the years have worked diligently to refine systems and processes, grounded in best practices, to ensure first and foremost patient safety, combined with the highest quality infrastructure and operation, in addition to productivity, which serves to help the clinical trials sponsor achieve their specific goals. Ultimately, in major research, such as a pivotal vaccine study, the star of this historic moment is the volunteer.
Accel Clinical Services subsidiary conducting the study is called Accel Research Sites (ARS). They offer volunteers first an appointment to visit the facility to learn more about the site, the study, and the investigational drug. If the prospective volunteer meets the study’s inclusion criteria and critically important, they read, understand and sign the consent form, they will be vaccinated with mRNA-1273 right on the spot. Thereafter, the Accel team will check in regularly on the participant to monitor the vaccine response, reports Dr. Lora Parahovnik, vice president of clinical operations. Showcasing the center’s collaborative ethos, Dr. Parahovnik told FOX 35, “its teamwork, and the patients are like family for us.”
Accel Clinical Services
In operation since 1998, Accel Clinical Services (ACS) has enrolled over 12,000 patients in over 1,0000 clinical trials. Over the years, they have developed a robust, deep network of investigational sites known as the Access Trial Connection Network. So ACS is not one physician site but actually a sophisticated operation spanning a network of sites across the United States.
Led by Matthew Maxwell, a seasoned and deeply committed health care executive that TrialSite has had the opportunity to discuss research with, the organization recently went through a rebranding to more clearly convey the core value and competencies of the organization. According to a recent press release, Maxwell commented that “The name Accel Clinical Services truly represents our portfolio of companies dedicated to supporting independent physicians and their patients in the delivery of high-quality medical care.”
But what are these different companies? ACS serves as the parent company to five subsidiaries to better align services around customers, not process. They include Accel Research Sites, Accel Trial Connections Network, Accel Patient Communities, Accel Provider Communities, and Accel Research Management. What follows is a brief breakdown of the organization.
Accel Research Sites (ARS)
As ACS oversees the various subsidiaries, Accel Research Sites (ARS), based in DeLand, is the flagship of ACS and continues to offer novel treatment options in all major therapeutic areas across the Southeast region of the United States. With over 20 locations, including a 62 bed Phase 1 unit in Florida and destination research units in Georgia and Alabama, the firm has also established “embedded research sites” within specialty clinical practices. As mentioned previously, ARS has conducted over 1,000 clinical trials recruiting over 12,000 patients.
Accel Trial Connections Network (ACTN)
Mr. Maxwell and team leveraged their professional networks, business partners, and relationships over the years to build a robust national network of over 140 certified research sites. A sophisticated operation compared to many site operations, they have invested considerably in business development resources for continuous prospecting to industry sponsors and CROs. Critically important, this helps drive new studies enabling ATCN to connect high-quality, appropriate studies from sponsors and CROs directly with high-quality research sites with the aim of 1) ensuring patients have access to the most appropriate investigational advanced treatment care options ,and 2) CROs and their sponsors achieve more efficient and accelerated study start-up. This is critically important due to the high costs and lengthy durations of clinical programs.
Accel Patient Communities (APC)
APC is a clinical registry of predictive health and medical data. APC seeks to serve patients, mapping them to the most appropriate and beneficial health and wellness options, whether that be preventative care or an advanced clinical trial. Over time, with accumulating data, APC allows researchers unprecedented insights into patients waiting on the next medical discovery.
Accell Provider Communities
TrialSite has spoken with CEO Mr. Maxell and was thoroughly impressed with his expertise and experience in the realm of health providers. Their provider community represents a network of complementary provider practices in physical and virtual spaces. Underlying this investment is the premise that independent physicians and patients benefit from greater clinical integration. Hence, Accel works to establish new medical destinations dedicated to improving quality of care.
Accel Research Management (ARM)
ARM represents a comprehensive research site a study performance management service for independent sites and site networks. They provide scalable, digital solutions supporting an efficient allocation of resources in the clinical trials process. For example, providers would employ ARM to free up resources so they can concentrate on their best use: providers and coordinators can focus on patient and participant care whether the study is centralized or decentralized (virtual) for example.
Central Florida is represented as a key region to recruit participants for the forthcoming Moderna mRNA-1273 Phase 3 COVID-19 vaccine trial. Approaching 3 million people, this region in the U.S. Sunbelt is home to a dynamic and diverse population spanning many of professions that would be considered at risk for COVID-19. FOX 35 recently was invited to tour Access Clinical Services’ research site facility in DeLand, Florida. The tone of the principals is confident and upbeat as they gear up to conduct one of the most important clinical trials in modern era as the United States, and the world faces the worst public health crisis in modern times with COVID-19.
Accel Clinical Services was selected for the Moderna mRNA-1273 Phase 3 clinical trial. With two studies already ongoing, mRNA-1273 looks very promising but of course until this Phase 3 trial can be conducted no one can be certain whether the investigational vaccine is truly effective. Hence the critical importance of volunteers—why residents of Central Florida will be stars, along with the participants from other regions, should this drug be deemed ready for commercialization.
In this brief, the TrialSite Network also learned more about Access Clinical Services, an important research organization for sponsors and CROs to partner with clinical research in Central Florida, the Southeastern U.S., and to other locations in their network.