We looked for a niche and put ourselves in it - Continued ...

Jason deBruyn, Staff Writer, Triangle Business Journal, January 15, 2016

Instead, they work solely on the business end of clinical trials, helping drug companies in areas like contract negotiations, budget development, site payment and resource placement to make sure those clinical trials run without a hitch.

The Clintrax founders worked together closely in the business office of PRA Health Sciences, a global contract research organization. In some ways, there is irony that Clintrax was founded on the principle of outsourcing a small portion of a clinical trial. After all, the entire CRO industry came to life on the idea that drug companies should outsource clinical trials.

In order to apply to the U.S. Food and Drug Administration, or similar regulatory bodies around the world, pharmaceutical and medical device companies must run expansive trials on experimental new treatments to prove they are safe and effective for broader use. While CROs are good at the clinical aspect of a trial, they aren't as efficient at running some of the contract negotiations or budget management aspects of a trial.

To run a clinical trial, the pharmaceutical company - called a "sponsor" in the industry - contracts with health centers around the world to recruit a targeted patient population in which to test a new therapy. This requires contract negotiations, budget management and payments to the health system. Sponsors can outsource this work to a CRO, and companies like Quintiles, PPD, Parexel and others have grown this into a multibillion-dollar industry.

However, the industry focused so heavily on the clinical aspects of running a trial that it didn't perform so well on the financial aspects. Recognizing this from their days at PRA, Evans, Easley and Jones founded Clintrax with the purpose of carving out that niche.

"It really becomes a bottleneck to get the trial up and running," says Evans. "It's a pain point for CROs."

Clintrax works to gain an understanding of laws in other countries that could affect a trial. It staffs people who speak the local languages to improve contract negotiations. It researches how best to make payments to health centers and manages the payment cycle.

"We developed a way of doing contracts that we thought was pretty innovative," says Jones.

Clintrax has not taken any outside investment and the founders say they are proudly bootstrapped. It helped that they signed on a big (undisclosed) contract in the first days as a company. It has now grown to 29 full-time workers in the United States, another 10 around the world and about 50 part-time workers.

The company closed 2015 with $7 million in revenue, an increase of 1,800 percent from 2013. It will likely rank on the 2016 INC 5000 list, and the founders see nothing but growth ahead. "It's been a fun three years," says Easley.

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