The secret to a long-running private clinical research firm? Lead with your gut.

Lynne Merriam was working as a nurse in an emergency room in the early 1990s when a leadership position in the research department opened up. She saw the opportunity to make a switch. “That’s how I got into research and I learned it from the ground up,” she says. 

She later went into private research and started Gulf Coast Clinical Research with two other physicians. She bought them out and reincorporated as Clinical Research of West Florida in 1995. The firm specializes in medicinal research of mass marketed drugs. Pharmaceutical companies will inquire with projects needing a certain population size and type, and if it's a go, gathering the right group of people can take months and the trial length can be years — a long cycle the firm has done well in.

Merriam's son, Aydin Keskiner, joined as vice president in 2002. His background in finance primed him to take control of the business angle of the clinic and together, the two grew the company to roughly 50 employees and many other partners and contractors. (The mother-son team declines to disclose revenue data). Lynne felt comfortable enough to leave Aydin in charge as CEO when she retired in 2019.

"It’s really important to us that there is a legacy in our industry and in Tampa," Aydin says. "We want to protect that legacy and make sure that we're going to be here because what we're doing is so important in terms of helping get to market and make sure it's safe for the next generation of breakthrough medications. I tell my younger employees that what you're doing here in Tampa, Florida is impacting people all over the world. Don't ever forget that."

Now, CRWF is 30 years in with locations in Clearwater and Tampa. The familial duo recently reflected on the history of the company and the private clinical research sector in an interview with the Business Observer. Edited excerpts: 

Why do pharmaceutical companies choose private clinical research? 

Lynne: Government funded research or grants are still being done in hospitals and in university settings where a doctor has an idea and wants to do research. They do more of the orphan diseases, where there aren't thousands of people that have this.

When you are in a very contained hospital setting, everything is so rigidly controlled that when they mass marketed drugs, they found that they didn't work. You have to do it in a real life setting. By having community based research like we do, you have a better chance of picking up on something that might not work. 

How do you find subjects? 

Aydin: It's a multi-pronged marketing and recruitment effort to get the targeted number of patients. It can take us a couple months, and it takes time to find the number of people needed to participate in the study. We work with physicians, we have social media, we do digital marketing, we work with agencies and we have a database.

What sets you apart in the market? 

Aydin: Each time someone comes to us about a new project, one of the big questions is: do we have the right setup to find the patients that they want us to find? Are we going to find them in Tampa? Do we have the capabilities? We don't want to take on a project if we don't have a pretty good chance at success.

Lynne: We take on projects that aren't always the easiest projects, so we tend to get selected for some of the more complicated ones and we have a very professional staff. Some of the research companies have hired people that aren't nurses and don't have a medical background, so we made the decision to hire well trained professionals. 

How do you gain patient trust?

Aydin: Not everyone understands what clinical research is all about. We're not wearing lab coats and sticking guinea pigs. We're really here to help people with their treatments and offer novel options that aren't currently mass market available. And if they work, that's what we hope. If they don't work, we're quick to take them out of a study or make changes.

Lynne: We do spend time with the patient going through the study and answering questions. It's very important that it is truly informed consent, and the person has a level of understanding that they know what they're agreeing to. That's done up front during the screening process. 

What are some challenges you face? 

Aydin: Protocols are written in a manner where the FDA, the government and the pharmaceutical companies have an idea of what they want to see from the medication, and they're looking for very specific patients. Sometimes we have someone who is very eager and seems like they would be a tremendous patient, and there's one small thing or a lab value that eliminates them from participation. It's hard on the patient, it's hard on us. 

Lynne: We've been very lucky to have great people. But just like everyone else who's been through this last five-year period, staffing, hanging on to staff, finding new staff— it's challenging. It isn't the same world when people lived in the same town, in the same house and stayed with the same job for a lifetime. There's much more mobility. 

What is the secret to your success? 

Aydin: We're a service business at the end of the day, and it's about the quality of your team. I've always felt, from top to bottom, we've tried to build the best organization with the best culture, even at our size.

What does the future hold?

Aydin: Our intention is to stay independent for the foreseeable future. We're certainly entertaining all options and keeping an eye on industry trends, and if we feel that the future is where sites are going to either band together as an affiliated network, or if they're going to be part of one company and present themselves in that manner, then we certainly want to pay attention to it and potentially participate if that's where the industry is going.