Tag Archives: pharmaceutical companies

clinical research advantage - vaccines

Radiant/CRA Enroll 8,000 for Hepatitis B Vaccine Study

Radiant Research/Clinical Research Advantage (Radiant/CRA), the country’s largest wholly owned clinical trial site management organization, has completed enrollment for the Dynavax Technologies Corporation (Dynavax) phase III clinical trial of HEPLISAV-B™, an investigational adult hepatitis B vaccine. 100 percent of the study was awarded to Radiant/CRA. Forty Radiant/CRA Sites are conducting the trial, which has randomized over 8,250 adults, including over 1,100 diabetic subjects. The sites completed the enrollment three months ahead of schedule without the use of an outside recruiting company.

Radiant/CRA is breaking ground with this study because 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. As the largest wholly owned clinical trial site management organization in the U.S., 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 have previously,” 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 clinical trial sites to conduct large-scale trials. We have everything they need within our wholly owned network.”

By working with Radiant/CRA, pharmaceutical companies and CROs can conduct studies with greater efficiency and ease while ensuring that they will receive high quality data. “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 COO of Radiant/CRA.

The partnership between Radiant/CRA and Dynavax has shown that this new option for conducting clinical trials offers a variety of benefits. “Utilizing a single site management organization to recruit patients and conduct the trial has made the process more efficient and more cost-effective,” said Rob Janssen, Chief Medical Officer of Dynavax.


Tempe’s CRA acquires Radiant Research

Tempe-based CRA Holdings, LLC announced that it has acquired Radiant Research, Inc. CRA Holdings is the company that also owns Clinical Research Advantage (CRA), another major player in the SMO market. By combining these two entities under the same investment portfolio, the organizations collectively have 57 sites with more than 550 research professionals and an aggressive plan for growth.

Over the past 15 years, Radiant Research has focused on common and chronic conditions that can be recruited from the general population. Radiant specializes in trials that require large numbers of subjects to be recruited in a short period of time, or complex trials that require specialized equipment or procedures. Radiant has large stand-alone facilities in which it conducts research; the company recruits studies primarily from an active database of over one million volunteers. CRA, on the other hand, is a practice-based organization, where 85% or greater of trial participants are recruited from the investigator’s private practice. This has allowed CRA to focus on trials where disease-state management is required. Both organizations are leaders in vaccine trial execution. The union of these two companies provides for better access to patients, an ability to conduct a diverse array of trials and broader geographic diversity.

“The Radiant platform will facilitate faster expansion of our model by utilizing the Radiant sites to help launch practice-based satellite locations in the cities where Radiant already has sites. We have grown CRA from seven to 37 sites in the last five years. In order for us to achieve our goal of 80 or 90 sites in the manner we have been doing would take us at least another five years.  The Radiant acquisition will be the catalyst for much faster growth in the next 12 months,” said Mark Hanley, CEO of CRA.

“By combining the models under one umbrella, we will be able to conduct almost every type of trial, be it point of care or studies more appropriate for a stand-alone research facility,” said Julie McHugh, CEO of Radiant Research. “We have been looking for a partner that has a shared vision for growth without any sacrifice in quality. In CRA, we have found that partner.”

The combined companies will continue to function under the names of Radiant Research and CRA, but will be looking to integrate and streamline their operations in areas where integration makes sense.

Tempe-based CRA is a provider of a range of research services to pharmaceutical companies and clinical research organizations. As a leading trial management organization, CRA operates from 37 sites across 17 geographic markets nationwide, helping trial sponsors bring drugs to market more quickly and efficiently. Founded in 1992, CRA has successfully completed more than 1,800 clinical trials on behalf of its clients. For more information, please visit www.crastudies.com.