Monitoring and FDA Consultations

CCTR assists investigator-initiated studies by providing remote/on-site interim monitoring visits, assisting in the creation of the data and safety monitoring plan, and the development, implementation and closure of corrective and preventive actions (CAPA). 

FDA regulatory consultations are available to investigators interested in submitting a Pre-IND or IND application. 

If you would like to set up monitoring visits for your investigator-initiated studies or an FDA regulatory consultation, please contact Sarah Marie Huban.