The Clinical Trials Office provides dedicated clinical research support to clinical investigators and sponsors providing them with the personnel and facilities necessary to conduct and facilitate pediatric and adult clinical trials. Our team provides a centralized infrastructure of research support for study budgets and contracts, regulatory affairs, participant recruitment, IND/IDE support, internal monitoring, project management and coordination of clinical research studies.
“The Clinical Trials Office is professional and knowledgeable about protocols. They are outstanding guides through the process of conducting a clinical trial from GCP training to closing out the study.” - Nicole Mihalopoulos, MD, MPH
“Our Clinical Trials Office and Research Coordinators play an integral part of our research enterprise. The Research Coordinators are knowledgeable, detail oriented and effectively communicate with our institutional investigators to ensure proper study conduct/compliance and data reporting.” - Andrew Harris, MD
We provide dedicated study support to principal investigators for industry sponsored and investigator initiated trials and clinical research studies from start-up to close-out.
INDUSTRY SPONSORED TRIALS
DURING THE PLANNING / SELECTION PROCESS:
- Set up processes to refine study quality and improve timelines
- Initiate and coordinate site qualification and site initiation visits
- Negotiate Confidential Disclosure Agreements (CDA), Clinical Trial/Study Agreements (CTA/CSA)
- Develop and negotiate study budgets
- Conduct regulatory oversight, including FDA IND/IDE submissions
- Provide internal quality assurance and monitoring for full compliance
- Plan and conduct investigator meetings and study staff training
- Design and implement recruitment and retention strategies
DURING THE STUDY:
- Provide research staffing to meet all study needs
- Facilitate sponsor’s site assessments and monitoring
- Conduct regulatory oversight, including IRB submissions, regulatory binder maintenance, and FDA IND/IDE reports
- Provide internal quality assurance and monitoring for full compliance
- Monitor financial performance and renegotiate budgets
- Assess and promptly resolve any study-related operating or regulatory issues and queries
- Assist with and coordinate FDA and sponsor audits
INVESTIGATOR INITIATED TRIALS
DURING THE PLANNING / SELECTION PROCESS:
- Facilitate protocol design
- Set up processes to refine study quality and improve timelines
- Negotiate Confidential Disclosure Agreements (CDA), Clinical Trial/Study Agreements (CTA/CSA)
- Develop and negotiate study budgets
- Conduct regulatory oversight, including FDA IND/IDE submissions
- Provide internal quality assurance and monitoring for full compliance
- Plan and conduct investigator meetings and study staff training
- Design and implement recruitment and retention strategies
DURING THE STUDY:
- Provide research staffing to meet all study needs
- Conduct regulatory oversight, including IRB submissions, regulatory binder maintenance, and FDA IND/IDE reports
- Provide internal quality assurance and monitoring for full compliance
- Monitor financial performance and renegotiate budgets
- Assess and promptly resolve any study-related operating or regulatory issues and queries
- Assist with and coordinate FDA and sponsor audits
Leadership
J. Michael Dean, MD, MBA
Associate Dean for Clinical Research
Professor
Vice Chairman for Research
Department of Pediatrics
Director, Clinical Trials Office
Chief, Division of Pediatric Critical Care
University of Utah School of Medicine
Contact Us
Contact Us:
Phone: 801-587-7514
Email: ClinicalTrialsOffice@hsc.utah.edu