Biodosimetry After Radiological and Nuclear Events – Demographic Study

Client: Industry Partner/Biomedical Advanced Research and Development Authority (BARDA), U.S. Department of Health and Human Services

Client/study focus and needs: The clients’ goal was to perform a regulatory compliant clinical study with 250 participants to advance the development of a high-throughput biodosimetry diagnostic system that would provide the capability to perform a large-scale radiation exposure diagnosis or triage rapidly in the event of a major radiological event within or near a major metropolitan area in the United States.

Our customized approach: Our role was to perform the clinical study from inception to completion. We set up and ran the study and analyzed the laboratory results to identify whether the device under development required different calibration curves for different demographic groups or other medically important subsets of the U.S. population.

We worked with the clients on study design; developed the full Good Clinical Practice (GCP)-compliant study documentation; contracted and monitored the clinical site and participant enrollment; managed, analyzed, and archived study data; and produced final Clinical Study and Statistical Analysis Reports at the completion of the study. This required resources, capabilities, and experience the clients completely lacked.

Services: Clinical study design; development of study documentation; clinical site contracting and monitoring; clinical database development, data management, and archiving; statistical data analysis; Clinical Study Report

Results: Preliminary results of this effort were presented at the Radiation Research Society 60th Annual Meeting in Las Vegas, NV, 21–24 September 2014.