We are a team of highly motivated individuals with significant expertise in human subjects research rules, regulations, best practices, and operations.
We provide guidance and support to our faculty and their teams.
areas in which we can provide assistance:
- FDA submissions
- Education and training on all aspects of study start up and management
- Assistance with IRB submissions
- Access to and maintenance of ClinicalTrials.gov records
- Research agreements (confidential disclosure agreements, clinical trial agreements and materials transfer agreements, as examples)
- Study drug/device management advice
- We manage OnCore, the clinical trials management system