Just three years after its formation, Raleigh-based Clintrax Global, which provides study site contracting and payment services, has been acquired by WIRB-Copernicus Group (WCG), the world’s largest provider of regulatory and ethical review services.

Clintrax, which will continue to operate as an independent company, negotiates clinical trial-related contracts and budgets between biopharmaceutical companies, CRO and investigator sites around the world. The company also manages, executes and tracks payments between global trial participants.

The acquisition was a good fit for WCG, which provides solutions to improve the quality and efficiency of clinical research by addressing a growing industry need to reduce administrative delays in trial startup, according to WCG Chairman and Chief Executive Officer Donald Deieso, Ph.D. 

“We had a clear sense from our clients that of all of the costly time delays, a major reason was how long it takes for a drug company to develop a budget [for a study] and how long it takes their legal department to conform contracts with which the investigation and trial would proceed,” Deieso said. “We looked to find a solution, and Clintrax was the answer.”

The Clintrax founders, who came from a CRO background, formed the company after recognizing that budgeting and contracting were a major impediment to activating a clinical trial, and sometimes responsible for months-long delays. “We saw a need at the time for a vendor that would focus on the nonclinical aspects of a trial,” said Brandon Evans, Clintrax Global CEO.

“We saw that some of the parts lacking in international trials included the ability to understand the local laws, customs and regulations of a country, and to be able to speak with sites and doctors in local languages,” Evans continued. “So we decided to branch out and test those waters.”

Since opening its doors in 2013, Clintrax has accelerated hundreds of clinical trials in over 65 countries with a team of more than 60 attorneys around the world, using a proprietary technology-driven process.

Although the offer from WCG was unanticipated, the prospect of some type of merger was part of the company’s long-range plan, Evans said. “It was always in the back of our minds that we would partner with someone that provided some corollary services to what we were providing. While we weren’t actively searching for that, it was a welcome call to receive.”

WIRB-Copernicus Group came together in 2012, but the individual companies it comprises have earlier roots. The original founding company, WIRB, was established in 1968, and Copernicus Group Independent Review Board was founded in 1996. Since then, various companies have been added that have special expertise in specific aspects of the clinical trial process.

Some in the industry privately find today’s trend worrisome. Clinical research mega-companies may offer less choice and less competition. But others say that the sophistication and scope of today’s clinical trials requires the expertise, efficiencies and specialization that large companies have perfected.

Carefully planned acquisitions, Deieso believes, are key. “One of the most critical aspects for us is that clinical research is now fully global,” he said. “There was a time when clinical research was concentrated in North America. Now research has progressed to where trials are being done in many countries. So the global perspective offered by Clintrax was quite important to us.”

Deieso draws a parallel with medical practice, where the general practitioners of old have been succeeded by specialists and subspecialists. He attributes the changes in the industry to the intricacies of the clinical trial process, from how the right sites are chosen to the solicitation of subjects, from the technological systems behind the trial to the protocols for research.

“I think it’s the inevitable dance,” he said. “The whole process of drug development is getting more complex, especially as we take on some of the orphan diseases or cancer. In any other course of human endeavors, the more complex, the more a need for specialized solutions. It’s the natural evolution of increasing knowledge.”

Among those important specialized solutions, Evans points out, are services to expedite the start of a trial. “Startup is a much different activity from the actual performance of a clinical trial,” Evans said. “We’re seeing that split of defined services, where the pharmaceutical companies are looking for companies that can get their sites up and running faster, so they can get drugs to patients faster and to market faster.” 

Lisa Catanese, ELS, has been a medical writer and editor since 1986, covering clinical trials, medical research, newly approved drugs and devices, consumer health education, continuing medical education and more. She is a member of the American Medical Writers Association and is certified by the Board of Editors in the Life Sciences. Email Lisa@BlueBlazeCommunications.com.

This article was reprinted from Volume 20, Issue 11, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »