Regulatory Knowledge and Support

///Regulatory Knowledge and Support
Regulatory Knowledge and Support2018-08-21T08:44:48-04:00

Regulatory Knowledge and Support (RKS) provides guidance and support on regulatory governance including Institutional Review Board (IRB) and FDA.

We want to help you navigate through regulatory requirements more easily and help you ensure compliance.
Our services include:

  • Advice and support with IRB and FDA requirements
  • In-house Clinical Research Monitoring Service for Investigational New Drugs (INDs) and Investigational Device Exemptions (IDEs) to ensure quality and compliance
  • Assistance with submitting IND and IDE applications to the FDA
  • Consulting on ClinicalTrials.gov requirements
  • Navigating single IRB process

Contact
Christine Caldwell, JD, MA, CIP- Program Manager
317-274-2115
csego@iu.edu
Shola Jhanji, MA,CCRP-Clinical Research Monitor
317-274-2967
sjhani@iu.ed
Scott Denne, MD-Director
sdenne@iu.edu

Contact Us for Consultation!

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