Clinical Trials Unit
Our Clinical Trials Unit (CTU) provides a full range of clinical trial support services to internally funded and collaborative initiatives. It is comprised of mission-driven research professionals that have expertise in the following areas:
- United States Food and Drug Administration Regulatory Affairs
- Department of Defense and Federal Regulations
- Cooperative Research and Development Agreements
- Multi-site Regulatory Strategy and Regulatory Submissions
- ClinicalTrials.gov
- Clinical Trial Risk-based Monitoring
- Clinical research within U.S. military populations
Overview of CTU Services
The CTU can assist investigators and study teams with all aspects of their clinical trials. This team collaborates closely with our Clinical Core Facilities and Translational Research Division. CTU services include:
- Project Management
- Clinical Trial Design/Development
- Trial Coordination
- Trial Feasibility Assessment
- Site Identification and Qualification; Site Management
- Trial start-up and close-out activities
- Regulatory Affairs and Operations
- Quality Management
- Safety Management
- Clinical Trial Monitoring
Contact Us
Interested in having our CTU support your clinical trial? Inquiries should be made to cnrm-ctu@usuhs.edu. Regulatory inquiries should be made to cnrm-reg@usuhs.edu.