hyperCORE International (hyperCORE), a growing U.S.-based integrated site network, has added two more research sites to provide additional capacity required for its growth, including AGA Clinical Trials and Clinical Site Partners. Clinical research sites compete for industry sponsor business, and a number of factors can drive the need for size and scale that heralds the emergence of the “super sites.” As private equity capital flows in clinical research, it seeks to capitalize on the highly fragmented and inherently inefficient research site model—hence the various super site models that are now emerging.
A few different “super site” models are emerging from the “integrated site network” (such as hyperCORE) to an evolving “site management organization” to various private equity investor-led growth and consolidation plays from those that focus on specific “centers of excellence” to roll-ups that emphasize dominance in specific therapeutic areas, or specific study themes such as underrepresented and minority patients in specific therapeutic areas to those that center attention on geographic concentrations and even those that are a harbinger of a new concentrated “site organization” where the private equity-backed site consolidator not only has geographic coverage and targeted and select therapeutic concentration but also begins to behave like a CRO—e.g. they have the sophistication and expertise to run everything in house, such as systems and processes,, on behalf of the client. And with disruptive technologies and perhaps evolving paradigms new forms of clinical research models can emerge from decentralized trial site aggregators to turnkey research as care option enablers & facilitators—in theory, transforming standard physician practices into research centers on demand.
As an integrated site network, hyperCORE doesn’t actually own all of the underlying sites but rather represents a group of independent owners (e.g. typically means still owned by founders or independent business people) of the underlying sites that agree to come together and form a formal network—one that they claim is the second largest site network in the world with more than 80 sites across 5 countries. There are a handful of comparable emerging integrated networks, and at least with some of them, the true underlying intention centers on marketing, which can surely help a small independent site from a business development perspective. However, without considerable planning and investment in underlying operational and collaborative infrastructure, not to mention the establishment and operationalization of joint process and procedures, these marketing-based constructs can falter operationally at scale. The hyperCORE founding members include Benchmark Research of Austin, Texas; Clinical Trials of Texas of San Antonio, Texas; DIEX Research of Montreal, Canada; FOMAT Medical Research of Oxnard, CA; IACT Health of Columbus, Georgia; LMC Manna Research of Toronto, Canada; Research Centers of America (RCA) of Hollywood, Florida; and Wake Research of Raleigh, North Carolina.
New Independent Sites to Join the Network
AGA Clinical Trials, a multispecialty research site operates in both South Florida and Ecuador with about 10 employees. Led by CEO Dr. Maria Ximena Graber Vascones and Dr. Roberto Aguirre, they bring expertise in cardiovascular, dermatology, neurology, men’s and women’s health, gastrointestinal and vaccine studies and a significant access to Spanish speaking (Latino) patients in both South Florida and Ecuador. According to a LinkedIn search, they have only 6 self-associated with the firm while SCRS reports them to have 10 full time Clinical Research Coordinators with a combined 90 years of experience. They have reported a patient data base of 8,500—see their SCRS profile.
Clinical Site Partners LLC was founded by Ana Marquez, who is dynamic and very active in the clinical trials space in Florida. Clinical Site Partners is actually a holding of Ms. Marquez’ holding company called Marquez Clinical Site Partners (positioned as a SMO). Additionally, Ms. Marquez also serves as COO for Florida Pulmonary Research Institute in Winter Park Florida. It was in this position that she entered the clinical trials world nearly two decades ago. Clinical Site Partners appears to have few actual full-time employees and rather leverages the extensive network Ms. Marquez has developed over the last 15+ years operating in the clinical research site space.
A TrialSite News Comment
Clinical research sites represent the front line of the clinal trial—they are where the action is. They are so unbelievably important that we even named our digital medial platform after them. The emerging site models we discuss herein are important and various constructs are emerging, reflecting the unfolding market—from sponsor and CRO demands to executive vision and investor growth hypothesis. As biopharmaceutical, device and CRO client needs evolve, the site models will adjust and incrementally morph to meet market needs. Industry sponsor and CRO clients must consider selecting site networks that support their needs today and tomorrow—and not yesterday. Humans are creatures of habit. Many sponsors routinely use at least 30% of the same sites (and investigators) when the results aren’t always optimal.
There is some unique perspective here when it comes to site performance in the site activation, study start up and patient recruitment context; this author spent an intensive amount of time serving sponsors and sites, via the provision of services and technology, to help them achieve their objectives of more efficient, effective and GcP compliant clinical research execution.
The sites that the sponsor select can materially impact a clinical trial, which of course can represent an investment in the tens of millions to hundreds of millions. Unfortunately, a staggering number of clinical trials get delayed or just flat out fail to meet specified goals. Up to 45% of clinical trials are completed late while study-start up delays bother up to 70% of clinical studies while up to 80% of studies don’t meet their enrollment targets on time.
A number of industry initiatives sought to rationalize the site database management, selection and management process with mixed results at best. Applying sophisticated algorithms to tracking site performance—across different trials, in different therapeutic areas, across different times is extremely difficult; sponsors often struggle in this area more than they would like to admit. Although there is a lot of the clinical trials process that is procedural, turnkey and, hence, predictable, there is just as much, it seems, that comes down to unique study needs and, hence, the demands for “scalable flexibility.”
Hence, as these various super sites emerge, regardless of model, clients are conditioned for certain expectations and corresponding demands will intensify for specialized medical and/or scientific expertise, targeted patient access and professionalized medical, regulatory and administrative support. Cost conscious clients will expect more value-added bundled capability that can serve the needs of today and tomorrow. Competition will intensify, pushing super sites (and CROs for that matter) to more effectively leverage scientific and medical competencies, technology and process disruption for transformative results.