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Clinical Research Lab (CRL)

Centralized Regulatory Services (CRS):

(CRS) is a central core of unique Radiology research professionals with years of regulatory experience in pre-clinical and clinical studies of a variety of disciplines.

Our goal is to help facilitate continuity and efficiency of regulatory submissions in order to improve study timelines from initiation to final approval, accelerate study start-up, and reduce PI time spent on non-revenue generating activities.  We will provide comprehensive support for all regulatory requirements including FDA submissions for Sponsor-Investigator exploratory IND applications as well as RDRC, HRPO and other WUSM regulatory governing bodies.

Regulatory Submissions Include

  • Food and Drug Administration (FDA)
    • Exploratory and other Sponsor-Investigator Investigational New Drug (IND)
  • Radioactive Drug Research Committee (RDRC)
  • Internal Review Board (IRB) - Human Research Protection Office (HRPO)
  • Protocol Review and Monitoring Committee (PRMC)
  • Clinical Research Unit (CRU)
  • Plus other regulatory submissions
  • Animal Studies Committee (ASC)

Benefits of Centralized Services

  • Reduce regulatory and administrative burden
  • Improve continuity and efficiency of regulatory submissions
  • Improve timeline to final approval and study start-up
  • Improve operational efficiency
  • Ensure regulatory compliance
  • Reduce risks to the university

Contact Deborah Koudelis at koudelisd@mir.wustl.edu for more information on CRS request.