Clinical Trials Support

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

J. Michael Dean, MD, MBA

Associate Dean for Clinical Research
Professor 
Vice Chairman for Research
Deptartment of Pediatrics
Director, Clinical Trials Office
Chief, Division of Pediatric Critical Care
University of Utah School of Medicine

Jaci Skidmore

Director, Clinical Research Operations

CONTACT US 

Phone: 801-587-7514
Email: jaci.skidmore@hsc.utah.edu

UPCOMING EVENTS

Research Professionals Grand Rounds

For more information, contact:
Jaci Skidmore
jaci.skidmore@hsc.utah.edu