Stanford

Regulatory & Compliance — Support Services, Resources and QuickLinks

Set-Up Your Study

The STUDY SET-UP stage includes activities that occur after the study has been designed and developed, and before you begin to enroll patients.

This stage includes activities in areas such as:

  • contracts & grant proposals
  • IRB approval
  • research management compliance
  • study budgeting & billing
  • required registration of trial
Primary Contact

If you don't find what you are looking for, give us a call.
Contact Spectrum  email

Regulatory and Compliance support services provided by OTC include:

  • FDA audit preparation and facilitation
  • Sponsor audit preparation and assistance when requested
  • Support for IND and IDE submissions
  • Good Clinical Practice support and study review
  • Regulatory Binder preparation and compliance review
  • Consultation for any regulatory or compliance question, whether FDA, OHRP, or ICH/GCP.
  • Support for billing compliance questions, liaison with hospital billing and risk management
  • Study document management: storage/archiving coordination and contract services
  • Liaison services for complex regulatory or compliance questions between RMG, OSR and the IRB
  • Liaison to Stanford Hospital and Clinics (SHC) and Lucile Packard Children’s Hospital (LPCH) compliance department

QuickLinks

Next Steps