The CRO had evolved to accommodate industry sponsors, develop relationships with interdisciplinary collaborators, and provide support to all Department of Surgery faculty wishing to begin, evaluate and continue, or close-out a study. Both sponsored, multisite clinical trials as well as investigator-initiated studies are supported by research administration and management practices of the CRO.

Regulatory Affairs

  • Management of IRB submission
  • Budget development and invoicing
  • FDA IND application
  • Investigator File management
  • Document development

Data Management

  • Design of Case Report Forms and other data collection tools
  • Database development
  • Data analysis

Compliance and Monitoring

  • Reporting of Serious Adverse Events
  • FDA audit preparation
  • Monitoring satellite research sites
  • Quality assurance for investigator-initiated trials

Clinical Affairs

  • Subject screening
  • Protocol specified procedures


CU Anschutz

Academic Office One

12631 East 17th Avenue

Room: 6111

Aurora, CO 80045


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