The individuals responsible for management, growth and development of clinical research sites are entrepreneurs. There is definitely evidence of expanded strategic development of innovative and entrepreneurial methods to garner new revenue, patient recruitment opportunities and visibility for the traditional, free standing clinical research site.

Some recent examples include the addition of a medical spa facility at the Meridian Research site in Omaha, Nebraska. Nikki Osborne, CEO of Meridian, initiated a business expansion in 2012 to allow for a potential crossover of patients taking part in spa services and interesting them in the many dermatology studies conducted by Meridian. This has proven to be a smart business move that allows Meridian to garner patients from the spa database to enroll in related trials.

“The addition of the spa has enabled us to seek out trials that would have a positive or beneficial impact on our patients,” Osborne said, adding that she wanted to diversify their therapeutic expertise into dermatology and “offer new, cutting-edge medications and cosmetic procedures to patients by getting involved in clinical research trials.”

In addition to the spa expansion in 2012, Meridian is opening a site in Guadalajara, Mexico in response to the needs of sponsor and CRO partners looking for a U.S.-based site network able to replicate operations in an international setting. The site is in the process of hiring staff and placing trials, and expects to be fully operational this quarter.

Another example of an innovative expansion activity involving a research site is Benchmark Research’s reorganized operating structure, which positioned its business unit, with an acute care setting, in Austin, Texas. Scott Barrett, former COO of Benchmark Research and founding member, will lead the Benchmark urgent and family care business. Additionally, key staff have been promoted to CEO Mark Lacy’s executive team, as they now operate from a newly purchased and renovated headquarters in Austin. These new urgent care facilities will be located in the same buildings as Benchmark’s research centers and will offer care for everything from minor emergencies to diabetes and high blood pressure management. By reorganizing its operating structure, Benchmark has aligned its research opportunities very directly with the acute care model.

Within my own group at Research Across America, we are in the final stages of receiving regulatory and sponsor approvals in order to conduct research in a mobile van. This will enable our site to expand marketing efforts in the Dallas-Fort Worth marketplace area and provide more generic advertising to increase clinical trials awareness. The goal is to help eliminate some of the challenges patients face, such as significant travel, time associated with participation or geographic challenges for those who may reside far from study centers. More often than not, potential patients are simply unaware of the possibility of enrolling in a clinical trial; we anticipate that incorporating a mobile unit into our operating structure will help increase the number of subjects willing to enroll.  

As sites continue to struggle to increase sustainability, it is critical to develop entrepreneurial methods of increasing revenue. There often is discussion of structuring the clinical trials process to become more patient-centric in order to make studies more accessible. Traditional settings might be inconvenient to the patients, as well as costly for the site to maintain. Rather than expect the patient to come to the trial, there are a number of ways to reverse the process and bring the trial to the patient.

Entrepreneurial methods are aimed at taking advantage of technology as it continues to mature in these settings. Telehealth tools have had a recent impact on the clinical health sector as mobile technology is increasingly being incorporated in clinical studies. Leveraging mobile technology has been shown to expand geographic recruitment areas for studies by reducing time and travel burdens on patients. These methods could not only help increase enrollment and lower dropout rates, but could improve the speed of data capture and significantly reduce the length of time spent on a study.

Trends are changing for sites as the clinical research process continues to be evaluated in terms of innovation. We believe we will continue to see new models for delivery that allow sites to develop sustainable processes in order to benefit all involved in bringing a new drug to market.  

Jeffrey Adelglass, M.D., F.A.C.S., is founder, owner and president of Research Across America (RAA), a U.S.-based, privately owned, multidiscipline CRO. RAA owns multiple research sites across the U.S. and has performed more than 1,800 clinical trials in multiple disease areas. Email comments and questions to jeffadel@gmail.com.

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