Industry-Sponsored Clinical Trials

The PRO has extensive experience conducting phase 2 and phase 3 industry-sponsored clinical trials. These often begin with a confidentiality agreement (CDA) that is negotiated between the sponsor and the investigator’s institution (UNMC). Our office works with UNeHealth on putting these in place.

Once a CDA is fully executed, the sponsor will share the study protocol and ask us to run a feasibility assessment. This allows both the site and the sponsor to determine if we are the correct place to run the study.   

Once chosen as a site, UNeHealth will negotiate the clinical trial agreement (CTA) and the Clinical Research Center, along with the PRO, will negotiate the study budget. Concurrently, a research coordinator from the PRO will begin the IRB application and supporting documents.

The PRO will work very closely with the PI and key stakeholders in the study to ensure proper research practices are conducted.

If you are interested in an industry-sponsored clinical trial, please review the PRO Intake Process and complete the PRO Intake Form to get started.