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 email@example.com for more information on CRS request.