Study Startup

  • Communicating Site Selection Status
  • Regulatory Packet Compilation + Distribution
  • Facilitating Document Receipt + Review from Sites
  • ICF Negotiations
  • Site Contract + Budget Negotiations
  • Central IRB Study Submission
  • IP Release
  • Ensure First Site Activate Targets Are Met
  • eTMF/CTMS data entry
  • Managing SUSAR site distribution and CIRB
    submissions, as applicable