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Services

Project Administration:
  • Regulatory compliance
  • Scientific review
  • Budget development and negotiation
  • IRB/VA/UMC/CTU/TUHC submissions
  • Project activation
  • Annual review and approval
  • Adverse event reporting
  • Data safety monitoring
  • Project status change
  • Study closure
Project Management:
  • Study organization and planning
  • Estimation of patient numbers
  • Patient pre-screening and screening
  • Informed consent
  • Patient entry
  • Obtaining and mailing specimens
  • Randomization
  • Case report forms
  • Follow-up
  • Study-drug compliance
  • Audits and inspection
Training and Education:
  • Trainings at affiliate sites
  • Two day training for new hires
  • Training materials and amendments distribution