About Regulatory Services

The Office of Clinical Research (OCR) provides support for investigators, sponsors, and research teams who are navigating the regulatory framework surrounding clinical research.

Our goal is to assist faculty in their pursuit of medical innovation and discovery while fulfilling all aspects of research ethics and compliance.

Facilitation Services provided to investigators include:

  • Provide Investigational New Drug (IND) Exemptions
  • Assist with IND Application and Submission to the FDA
  • Assist with Investigational Device Exemption (IDE) Applications
  • Provide consultation on management of multi-center clinical trials
  • Provide consultation on Data and Safety Monitoring Plans
  • Provide Monitoring Services
  • Provide assistance with preparation for FDA inspections and external audits
  • Provide Regulatory Sponsor training and education
  • Provide consultation on Procedure development (SOPs, MOPs)
  • Provide guidance on ClinicalTrials.gov Registration Requirements
Contact a Regulatory Support team member:

(215) 662-4484 or psom-ocr@pobox.upenn.edu