Based in Atlanta, Ga., Florence Healthcare is a software company focused on eliminating inefficiencies in the management and operation of clinical trials.
Recently, Gunnar Esiason, a principal in the company’s thought leadership department and leader of patient-facing strategy, sat down with Drug Store News to talk about how the company’s software platform improvesthe workflow of clinical trials by connecting sites and sponsors, thereby speeding up clinical trials and getting life-saving drugs to patients more quickly.
Drug Store News: What led you to assume your role in leading a patient-facing strategy? Gunnar Esiason: I am a patient advocate living with cystic fibrosis. I’ve spent more than half a decade in several phase 2 and phase 3 clinical trial programs. While I was fortunate enough to be in a trial that worked well, I also spent plenty of time in trials that have failed. I’ve seen firsthand how inefficiencies in clinical trials impact patients. Everyone thinks of clinical trials as a highly innovative and super streamlined event, but in reality, being in a clinical trial is extraordinarily cumbersome and inconvenient.
DSN: What is Florence Healthcare’s mission? GE: Florence is a software company focused on connecting sites and sponsors in more meaningful ways to help speed up the clinical trial process and improve patients' lives faster.
DSN: How does Florence Healthcare’s software platform benefit the retailers who are becoming more involved in clinical trials? GE: Florence Healthcare’s software supports centralized regulatory, consent and remote monitoring workflows. We enhance the workflows of clinical trials. That allows clinical trial teams to get more done with less investment in both their time and the resources required to run trials. That means staff can focus more on taking care of patients and less time on the administrative tasks of operating trials.
DSN: What are the challenges related to the execution of clinical trials? GE: We take away the operational nightmare of getting a trial up and running at a site that’s not a medical center by deploying the technology that is required. Retail pharmacies may not have the technical know-how to get a clinical trial up and running that a large medical center may have. Florence centralizes everything through our technology so that everything is in one place, unlike using pen and paper. We also support connections between sites, sponsors and CROs, so sponsors can instantly see documents and data at the sites they’re collaborating with.
DSN: How does Florence Healthcare’s software platform increase workflow efficiencies of clinical trials? GE: Florence’s software makes it possible for point-of-care retailers to support the management of trial activities. That means collecting paperwork, and documenting different parts of the clinical trial and different parts of the visit. And these point-of-care retailers are near more patients. The issue that exists in clinical trials right now is that there is a lack of diversity among trial participants. While 70% of the U.S. population doesn’t live near a major academic medical center, 80% of the population does live within 25 miles of Florence-enabled research sites (for example, inside a retail chain pharmacy) that are equipped with our technology.
DSN: Compliance is critical in clinical trials. How do you help retailers with compliance issues? GE: Our technology brings compliance know-how to the table and makes it easier and feasible for the staff or site that have never run a clinical trial before to remain compliant. We have compliance features like audit trails and version control built in, so staff at retail pharmacies or labs don’t have to worry about performing those functions themselves.
DSN: What are the key benefits of Florence Healthcare’s software for retailers? GE: We reduce the time and resources required to manage paper trails. With the economy impacting us and affecting the hiring of clinical trial staff, and the number of clinical trials increasing, our software makes clinical trial operations less dependent on people to do the physical administrative tasks of operating clinical trials.
Additionally, the Food and Drug Administration’s recent draft guidance suggests that diversity in clinical trials is seriously lacking. Clinical trials need to change to enable participation for historically underserved communities, and that means academic medical centers can no longer be the only hubs for clinical trial programs. Our technology links retail pharmacies to an essential hub that allows clinical trials to be moved into the community and outside these hospital centers. We allow the operational know-how to get into retail pharmacies so that the clinical trial can get into a community and out of an academic medical center.
Finally, the value to all clinical trials is we are taking the time and energy out of the operational part of the entire life cycle, from startup to execution of the clinical trial.
DSN: How do you foresee the future of clinical trials? GE: I participated in clinical trial programs when I lived in New York, and commuting from Long Island into New York City, which took almost an hour and a half each way, was brutal, but I had no other option. I was very sick, almost at end-stage disease. When I was in grad school in New Hampshire, I was in a clinical trial at an academic medical center affiliated with the university that was five minutes away. That made participating in that trial so much easier. I have lived the value proposition of having a clinical trial site right in my backyard, but not everyone lives five minutes from a site. That’s hopefully what will happen in the trials of tomorrow when retail pharmacies are widely involved.
I would love for clinical trials to no longer be confined to academic medical centers exclusively, especially for vaccine trials or trials that don’t require intense medical intervention. It makes a lot of sense for clinical trials to be in the community and closer to the people who enroll in them.
The amount of time that people spend to receive clinical trial care is mind-numbing. Clinical trials should be done at a patient’s convenience. I’m certainly enthused that the major pharmacy chains are taking clinical trials on. In the context of terminal illness, inefficiency translates to time lost and patients pay that cost with their lives. I’m a fan of anything that can be done to make clinical trials more efficient.