Our team of Clinical Research Support professionals can offer guidance and support for faculty and study teams at the University of Colorado Anschutz. Our seasoned regulatory specialists are here to help navigate the various regulatory requirements for research involving human subjects.

Our goal is to provide appropriate and timely guidance and help you develop a strategy to get your study open and running smoothly from start-up to close-out.

Services include:

  • Assistance with ClinicalTrials.gov submissions and maintenance
  • Assistance with IRB Document Prep
  • Assistance with requesting reliance on an External IRB
  • Assistance with submitting a new research agreement: clinical trial agreement, material transfer agreement or confidential disclosure agreement
  • Education and training
  • FDA Audit Prep
  • FDA submission assistance and guidance
  • Quality Assurance
  • Site initiation visit prep
  • Tools and Templates to set up your Researcher Toolbox