The Team Behind the Trials
| Good clinical trial research should be easy to start, run efficiently, and deliver health care impacts for patients.
At the Clinical Trials Innovation Unit (CTIU), part of the Translational Research Institute at the University of Arkansas for Medical Sciences (UAMS), these ideas shape the team’s work.
The unit is a comprehensive support system designed to help investigators navigate the complicated world of human-based research, said Al Keyes, director of clinical trials within the CTIU. The unit supports both investigator-initiated and industry-sponsored studies and focuses on improving study quality while streamlining start-up timelines.
“CTIU consists of our study coordinator team, regulatory team, start-up, and finance team (front and back end),” Keyes said. “In a nutshell, our study coordinators provide a resource to clinical investigators looking to delve into a research study who require assistance with data collection, entry, recruitment, consenting, and more.”
The start-up team collaborates with sponsors and investigators to determine feasibility and coordinate site qualification and initiation visits. The regulatory team ensures documentation is complete and works with institutional review boards and legal teams, so protocols meet all requirements. Meanwhile, finance staff ensure budgets properly support study needs and that research charges are billed correctly so participants are not mistakenly charged.
Together, these teams create a structure that allows investigators to focus on the science while CTIU manages the infrastructure.