Information for Clinical Trial Sponsors
Clinical trial sponsorships are vital to our mission of conducting cutting-edge cardiovascular research and increasing the accessibility of state-of-the-art treatments to patients across Kentucky, the country, and the world. Every aspect of the Gill’s research operations—from our staff to our space to our systems—are maintained to ensure strong and efficient partnerships with sponsors:
- Resources and technology: In addition to utilizing the local UK IRB through the Office of Research Integrity, our Gill research teams employ a fully electronic submission system for IRB applications and the Allscripts EMR platform. We also offer leading-edge research technology and advancedcardiovascular imaging modalities.
- Highly experienced staff: Our dedicated Gill team members include regulatory specialists, research nurses, research associates, and DOT/IATA-certified coordinators, as well as a program coordinator dedicated to the biorepository program—all led by the Gill Heart & Vascular Institute (GHVI) Clinical Research Organization (CRO) director.
- Easily accessible: All of our clinical research staff at the Gill are located on-site at the University of Kentucky, with easy access to hospital and ambulatory spaces including the hospital clinical laboratory, echo lab, vascular lab, and cardiac catheterization lab with interventional capabilities, as well as advanced imaging technology.
- Fully equipped: The GHVI CRO is designed to facilitate all aspects of patient-based clinical research, including coordination of phase I-IV multicenter drug and device trials, investigator-initiated protocols, and translational studies. We offer an on-site investigational pharmacy, dedicated research storage and monitoring space with Wi-Fi, and centrifuge and storage areas for biospecimens.
- Innovative, industry-leading approaches: The strength of our clinical research efforts at the Gill is unmatched. We are leaders in cardiovascular treatment research, including hypertension, left atrial pressure monitoring for heart failure, coronary and vascular interventions, and stem cell regenerative medicine. Historically, the Gill has been a top enroller in multicenter trials investigating novel devices for patent foramen ovale (PFO) closure, left atrial pressure monitoring, and atrial septal defect (ASD) closure, as well as novel drugs for treatment of acute coronary syndrome (ACS) and pulmonary hypertension and the prevention of secondary coronary events. We employ particularly innovative catheter-based approaches to heart andvascular disease.