In a move that reflects the ongoing trend of consolidation in the industry, Maryland-based Chesapeake IRB, one of the earliest independent institutional review boards, has acquired Arizona-based Compass IRB.
The acquisition is the fourth for Chesapeake in the last three years and broadens the company’s geographic presence across the U.S. and Canada. It provides Chesapeake, established in 1993, with additional AAHRPP-accredited review capacity, according to Jeff Wendel, president and CEO of Chesapeake IRB.
As an increase in multicenter trials has moved the industry toward central review models, IRBs are merging to create economies of scale in providing more effective and efficient oversight. “We’ve been focused on acquiring entities that share our philosophy of subject safety and customer service, while maintaining the important role of the IRB to provide independent review and determinations,” Wendel explained.
For Compass IRB President Matt Baker, who founded his company in 2006, the acquisition presented an ideal opportunity for Compass to expand and enhance its services. “When we began, we were focused specifically on rapid startup for sponsors,” he said. “As a homegrown system, we would increase our services as we could, but we couldn’t fully invest in the resources that we wanted.”
Although he had been approached in recent years by other IRBs interested in a merger, Baker chose not to pursue any ventures until now. “As I saw the industry changing, with more consolidations, I looked at options where I would feel most comfortable,” he said. “We’ve had a professional relationship with Chesapeake for several years, and it became apparent that we have very similar philosophies.”
Among those philosophies is how to leverage technology as a way to grow in capacity, while still delivering personalized services tailored to sponsors’ individual needs. Chesapeake offers a unique cloud-based, 21 CFR Part 11-compliant, electronic IRB platform—a fully transparent and paperless system on which all submissions and management tasks are performed, documented and available at any time for audit purposes.
“It was a more robust platform than we had,” Baker said. “As the industry continues to move forward, this level of technology has become necessary.”
This platform, CIRBI, is a key differentiator for Chesapeake, Wendel explained. The system enables staff to better serve research partners with prompt reviews, resulting in faster subject enrollments. He compared the CIRBI platform to tracking systems that transformed the package-delivery industry.
“Every time a package is touched it gets scanned, and you can see where it is at all times. CIRBI has visibility much like that, but it also allows our clients to go right into data and documentation. CIRBI provides complete transparency into each and every step of the process and allows access to data 24/7. This drives our operational excellence and delivers predictability and safety.”
Wendel believes there will still be a number of privately held and managed smaller IRBs to fill certain specific market niches, but mergers and acquisitions have become the norm in today’s IRB climate. “The way the industry is going is pretty clear,” he points out. “The demands of industry sponsors mean IRBs must have the intellectual bandwidth to properly assess new study designs. That’s hard for smaller companies to maintain.”
Today, the independent IRB industry consists of four major players: WIRB-Copernicus Group (WCG), Quorum, Schulman and Chesapeake. Michael Woods, president and CEO of Schulman IRB, expects the consolidation trend to continue, but believes there will always be space for smaller IRBs with a more regional or niche focus.
He anticipates the next step in the industry to be an expansion of the relationship between commercial IRBs and research. “In the future, I expect to see independent IRBs working even more effectively with large research institutions,” Woods said. “Human subject research is a complex undertaking that is getting even more complex, and I think it will require those in the commercial IRB space to partner with universities and large research institutions for their expertise.”
As with other large IRBs, Chesapeake’s broadened reach has been supported by private equity investment. In December 2015, Chesapeake IRB was acquired from Audax Private Equity by Linden Capital Partners, a Chicago-based healthcare private equity firm.
“In Chesapeake’s case, we were making investments on our own,” Wendel said. “Engaging private equity allowed us to make larger and more transformative investments.” And because private equity demands a degree of excellence, the focus on high-quality has been maintained during the company’s growth, he added.
Greg Koski, Ph.D., M.D., co-founder, president and CEO of the Alliance for Clinical Research Excellence and Safety (ACRES), has watched the consolidation of independent IRBs—and the evolution of the entire research process—with interest.
“It really is the way of the future,” he said. “With these acquisitions, operations can often be streamlined. You can have economies of scale to reduce cost and drive efficiencies. As trials are done on a multiregional or global basis, there’s a need to move to greater consistency with regard to ethical reviews and human subjects protection.”
As to the role of private equity, “who would have ever thought that ethical review would become an investment opportunity,” Koski said. But he acknowledges that the investment capital does allow for improvements that are becoming essential in today’s market.
“There are so many things in play right now—changes in the clinical research processes, precision medicine-focused trials, regulatory demands,” he said. “This is an amazing time that comes with opportunities and challenges. There’s room for improvement on every level as long as we all keep our eyes on the goal to get safe and effective medicines to those who need them.”
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 06, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »