Radiant Research/Clinical Research Advantage (CRA), a Tempe, Ariz., wholly owned clinical trial site management organization, has completed enrollment for the Dynavax Technologies phase III clinical trial of HEPLISAV-B, an investigational adult hepatitis B vaccine.
Forty Radiant/CRA sites are conducting the trial, which has randomized over 8,250 adults, including over 1,100 diabetic subjects. The sites completed enrollment three months ahead of schedule without using an outside recruiting company.
According to Radiant/CRA, this is the first time one clinical trial site management organization has been exclusively awarded a study that requires the enrollment of more than 8,000 patients. Radiant/CRA has 75 unique sites, which gives it the ability to conduct studies of this size.
“Our company is providing study sponsors with an option they didn’t previously have,” said Mark S. Hanley, CEO of Radiant/CRA. “Because we have 75 sites around the country—and we’re continuing to grow—sponsors do not need to seek out individual sites to conduct large-scale trials. We have everything they need within our wholly owned network.”
“When choosing our sites, study sponsors can conduct a large-scale trial using one contract, one budget and access to all of our sites and our database of more than two million patients. This helps to significantly reduce the time it takes to conduct the trial, while also reducing the cost of the trial,” said David M. Bruggeman, president and chief operating officer of Radiant/CRA.