Four small and mid-sized clinical research service companies—Averion International, Trio Clinical Research, Fulcrum Pharma and Clin-Research/ADDPLAN—have merged into one global biopharmaceutical and medical device development services organization that will focus on niche areas, including adaptive trials and new technologies, which can help sponsors make decisions about their drug candidates faster.

The merger was led by a group of investors including the Halifax Group, SV Life Sciences and the Comvest Group. Patrick K. Donnelly, formerly chief executive officer and a founder of PRA International, was named chairman and CEO of the new group. J. Matthew Bond, also formerly of PRA International, has joined the company as chief financial officer.

The newly formed company, which won’t be named until market research concerning the four merged companies is complete, will base its headquarters in Northern Virginia, outside of Washington, D.C., and employ 800 professionals around the world. Donnelly said the organization may acquire additional companies in order to build on its regulatory, safety, and health economics and outcomes research services.

While the global contract research organization (CRO) market continues to consolidate, with the five largest CROs now dominating more than 50% of the market, according to a study by Research and Markets, Donnelly said the new company won’t directly compete in this space. Instead, the company will focus on various niches, including adaptive trials, medical devices, orphan drugs, product development consulting, regulatory services, safety and pharmacovigilence, along with traditional CRO services such as monitoring and project management.

The company plans to differentiate itself by using new clinical development processes and technologies to address the challenges facing the biopharmaceutical industry today. “I don’t want to be yesterday’s CRO. The key thing is that it’s clinical development for the next
decade, not the past,” said Donnelly. “Companies just don’t have a billion dollars to bring a drug to market. They need to get to better decisions faster.”

Each of the four companies will bring a particular expertise to the newly merged company. While Trio Clinical Research, a rare CRO-staffing company hybrid, provides monitoring and project management services, U.K.-based Fulcrum Pharma has regulatory expertise needed to move development programs from research to product approval. ClinResearch/ADDPLAN offers service and software for developing adaptive clinical trial designs. And Averion International, a full-service global CRO that has conducted more than 600 trials, can provide services across all phases of development and has therapeutic expertise in oncology, medical devices and cardiovascular trials.

While both Averion and Fulcrum Pharma share a specialty in oncology studies, Donnelly said the company’s focus will be more about bringing new processes and techniques to drug development rather than touting therapeutic expertise in specific areas. “Everybody out there is saying, ‘We are the oncology CRO.’ It’s the largest market out there, so everyone wants to be that. But we want to take that knowledge to the next generation as far as being able to do adaptive trials with it. That’s a differentiator,” he said.

Donnelly envisions the company’s clients will include not only large and small biopharmaceutical and medical device companies, but also nonprofit organizations. Fulcrum Pharma, for example, recently completed a large malaria study for the World Health Organization. “We’re not trying to duke-it-out to get that last study from Pfizer,” he said. “We will work with Pfizer, but we will be a different sort of organization.”

—Karyn Korieth