Durham-based Velocity Clinical Research (Velocity Clinical) continues executing on its goal of expanding the company’s national base of research sites while transforming the research sector from one of many fragmented small sites and at times non-responsive networks to a more scalable model: one that looks like a clinical research organization. Today, the research organization announced the delivery of Day One doses for the Moderna Phase 3 mRNA-1273 clinical trial. As Operation Warp Speed-based research progresses to the pivotal Phase 3 clinical trials, known-risk factors emerge from challenges in patient recruitment to unforeseen scientific and patient observations that could potentially impede the expedited program. The full utilization of this new breed of research site may be timely; the Durham-based group with a national presence could very well emerge as the type of organization that can best help Operation Warp Speed maintain its timelines.
Founded in 2018, it seems like just yesterday that Chief Executive Officer Paul Evans announced the formation of this private equity-backed, rapidly growing clinical research organization. Launched to introduce a more enduring research model at the site level—more efficiency, scalability and productivity combined with safety and quality. In just a couple years, the firm has made a number of strategic and timely acquisitions while continuously recruiting experienced clinical research organization personnel in a bid to truly shake up the research site market in a positive and progressive manner.
Participating in All Major Vaccine Programs
The TrialSite learned of the recent Velocity Clinical Research news from a company issued press release. As it turns out, the company has secured Multi-Site Awards for (five) of the Phase 3 COVID-19 Vaccine Studies now or soon to commence in the United States. These awards involve 14 study-sites across 8 locations preparing to dose thousands of volunteers by the end of 2020.
The TrialSite reviewed all of Velocity Clinicals site facilities and uncovered that the Durham-based company appears to be one of the few, if not the only organization in the United States, that has been selected for all of the following COVID-19 vaccine trials:
- Moderna (mRNA-1273)
- AstraZeneca/Oxford (AZD1222)
- Pfizer/BioNTech (BNT162)
- Novavax (NVX-CoV2373)
- Johnson & Johnson (Ad26.COV2-S)
Thanks to the company’s adept and timely moves to secure high quality sites around the nation, Velocity Clinical now emerges as one of the most important site operations influencing the success of Operation Warp Speed itself.
In fact, given that the U.S. will require at least 250,000 volunteers in the next six months, all five of the vaccine programs share in common a contract with Velocity Clinical: the CRO-like,well-organized, disciplined and tightly managed trial site company that is already recruiting over 10,000 volunteers from a diverse set of communities. Velocity Clinical doesn’t sit still as the firm actively seeks to add capacity to the search for a COVID-19 vaccine by utilizing its wholly-owned block of clinical trial sites expanding across ten states and all four time zones.
Could Velocity be what OWS Ordered?
As Phase 3 COVID-19 clinical trials commence, much of the press serves as a positive cheerleader, often centering the attention on the positive targets, such as the declaration that Operation Warp Speed would deliver a safe and effective vaccine by January 2021. However, the actual risks for delay grow ever more probable as the studies progress into the pivotal Phase 3 stage. Why is that the case? More often than not, sponsors load up with large, academic medical centers based on the at times, faulty premise that scale and size will equal more patients. Often, the opposite is true. While the National Institute of Allergy and Infectious Disease (NIAID) reorganized a number of major academic-focused trial site networks to form the COVID-19 Prevention Network, many a number of well-intentioned centrally planned, federal experiments have failed, or at least faltered, in the past. Often what is needed are more dynamic, agile, and entrepreneurial focused, performance-based research units that align with the sponsor and, in this case, Operation Warp Speed. As Velocity Clinical combines flexibility and agility with process and system standardization and scale, the true risk mitigation measure may be in the form of a firm such as this one.
Hence, Velocity Clinical’s selection across all major programs addresses one of the main threats to the aggressive timelines in the race to find a coronavirus vaccine—the industry-wide need to dramatically scale up clinical trial site capacity while maintaining safety and social distancing for staff and volunteers.
A Private Sector Operation Warp Speed Site Network Emerges
The Velocity Clinical trial site network spans all five major COVID-19 vaccine programs: these sites are conducting COVID-19 studies and are based in:
- Banning, California
- Austin, Texas
- Cincinnati, Ohio
- Cleveland, Ohio
- Providence, Rhode Island
- Salt Lake City, Utah
- Boise, Idaho
- Medford, Oregon
About Velocity Clinical Research
Velocity Clinical Research, headquartered in Durham, N.C, is a leading site organization for clinical trials, offering dedicated site capabilities to help biopharmaceutical and contract research organization customers find the right patients for their studies. With over 35 years of experience and more than 4500 studies completed, Velocity sites have refined their patient recruitment strategies while maintaining a focus on delivering timely and reliable data quality, placing the care of the patient at the heart of everything they do.