Services

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