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Is This The Model That Will Trump Them All?

Dustin Caldwell helped Optimed Research become a centrally managed network with low-footprint local sites. Learn how the power of going paperless enabled this transformation.

6/27/2019 | By Raymond Nomizu, Co-Founder |

Site Networks

Give us the story behind Optimed Research

For 17 years, we were a stand-alone research site in Central Ohio. It was affiliated with a doctor's practice, and the site did a range of Internal Medicine studies. Starting in 2017, we changed the business model drastically. We created a nationwide, technology-based SMO. We took the legacy site in Ohio and folded it under this model. We've since expanded to 13 sites in nine states. We primarily seek to partner with physician practices. We look for engaged Investigators who may lack the experience or infrastructure to do research, and work with them to get their research function operational.

What is your business model? What makes it different?

We have a very strong "center." The center does everything a traditional network operator does: source studies, negotiate the study contracts and manage the financials. However, we're also 100% eSource and eRegulatory enabled, so we go one step further. We design and push the eSource template to the sites, then we do all the QC and EDC entry centrally. We also manage the regulatory binders.

So, what we have is a very strong center and very lightweight, local hubs. We make it much easier for the local physician and coordinator to be successful. We need a lower threshold of revenue for each research site to be profitable. And we create economies of scale by centralizing the source design, QC, EDC and regulatory functions. These functions allow us to standardize critical parts of the workflow, thus ensuring high quality delivery to sponsors and CROs.

We also made one major change to the staffing model from the traditional SMO model: the coordinators are on the payroll of the Investigators. This recognizes the tight working relationship the two need to have, and gives the Investigators real "skin in the game" since they are paying for the coordinator salaries. Of course, we adjust our model so we take a lower percent of the revenue than we might otherwise take, but this trade-off allows us to scale quickly without significant capital.

How do your PIs perceive this model?

They get a higher percent of the revenue, direct control over the coordinator resource, and a lot more centralized support than they otherwise might experience with a traditional operator. For instance, our eSource communicates directly with our Finance module, so as soon as the visit is done, the system knows exactly what is earned and outstanding. For the Investigator, that means full transparency, full reimbursement on all procedures performed, and none of the usual burden of having to track activities in a spreadsheet or separate system.

Where do PIs source their coordinators?

Many times, they appoint one of their trusted employees. At the beginning, they don't need a full-time employee, so this is a practical and cost-efficient way to staff. As they get bigger, they will need dedicated resources, and we will help them hire and train new employees as needed. That's a paid service that we provide.

With a fully tech-enabled platform, it's a lot easier to get a new hire up and running quickly since we take many of the operating workflows off the table. We can also QC their work quickly after the visit. If we have a relatively new resource, or someone who is struggling, we can provide very close to real-time feedback. That means we can recruit from a wider talent pool--we don't have to recruit exclusively from the small pool of experienced coordinators.

clinical research future model

Do you have any performance metrics that prove out this model?

We do. We track a range of metrics, such as time to close a contract, first patient in, average EDC entry time, average query response time. On these and other metrics, we have shown that our brand new physicians--i.e., investigators doing their first study--are performing well above industry standard, and in fact are performing at the same level as you would expect of high-performing experienced investigators. And that's entirely because of our centralized business model. We have proven that our model is scalable--i.e., that by working with us, sponsors can experience uncompromised quality, regardless of the individual investigator's experience level. That means they can partner with us to select the right physician with the right patient population access.

That's got to be very powerful. How have sponsors and CROs reacted to this model?

Positively, of course. More so the sponsors than the CROs. I think, in some ways, our business model encroaches on what CROs are supposed to deliver. But by gathering metrics and building proof cases, we know we're going to gain traction with pharmaceutical companies.

Did you have any challenges transitioning to this model?

We did, at our legacy site. When we made the transition, we had to transform our core operations first. That meant introducing a culture of accountability and metrics. Many of our staff members resisted, so we ultimately had to effect a lot of turnover, and bring in personnel we could train from the outset. It wasn't just resistance to technology; it was resistance to transparency and accountability more broadly. But ultimately, you have to make choices, and we chose to pursue the right business model, rather than compromise on quality by catering to the most resistant.

Are there any weaknesses to this model?

We're still adjusting and learning as we go. But we are confident this is the right direction.

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Raymond, CRIO's co-founder

Dustin Caldwell joined Optimed Research in 2013 when it was a single site in Central Ohio. He was initially appointed to manage efficacies and modernize operations. In the past six years, Dustin has helped Optimed become a centrally managed, multi-site operation, covering nine states.

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