CTI is a CRO focused on rare diseases while Community Research has a couple of trial sites, most of which are Phase I units. Edgemont advised Community Research as part of the deal and financial details were not made public.
Blume noted that the deal made sense logistically as both companies are based in the Cincinnati metro area, noting that CTI conducts Phase I-IV trials, “and similar to many other CROs, they think having an in-house Phase I unit would be good because they had been outsourcing Phase I work to other units.”
As far as how this deal portends for other trends, Blume said he thinks “we’re seeing a continued acceleration among the site sector and anticipate that would pick up steam into 2014 and 2015.”
More CROs are also now pushing into early phase clinical trials, Blume said, noting an “increasing appreciation for Phase I trials.”
“I think there are a number of factors contributing: Demand for more sophisticated sites…conducting more tough trials in Phase I and in more humans and the use of less healthy volunteers and more patients,” Blume said.
“Sponsors are moving toward studies in Phase I in actual patient populations and it’s the sites that are not part of CROs that have the advantage.”
CROs also seem to be moving their operations to slightly more expensive sites in the US and Western Europe.
“There was a point in time 4-6 years ago that the trend was moving outside the US – mainly India and China – but there were very significant quality concerns about data coming out of those studies, especially in India,” Blume said. “India is entirely closed off to industry right now and sponsors have come to recognize it’s not worth it to conduct trials in such a risky area.”
“And also there’s a lingering effect that it’s not worth it to consider a lower-cost region because the money we would save is not worth the risk of having to do another study because of data concerns,” he added.
Blume also said that he expects to see more consolidation among the small- and mid-size CROs, just as he said last summer , especially if they offer a tool or specialty that they can use to differentiate themselves among the competition.