Panacea Trial Support
  • Home
  • Services
    • Operational Support
    • Regulatory Guidance
    • Compliance Oversight
    • Start-Up Services
    • Financial Management
    • Patient Recruitment
  • Sponsors
  • Contact Us
  • More
    • Home
    • Services
      • Operational Support
      • Regulatory Guidance
      • Compliance Oversight
      • Start-Up Services
      • Financial Management
      • Patient Recruitment
    • Sponsors
    • Contact Us
Panacea Trial Support
  • Home
  • Services
    • Operational Support
    • Regulatory Guidance
    • Compliance Oversight
    • Start-Up Services
    • Financial Management
    • Patient Recruitment
  • Sponsors
  • Contact Us

Regulatory Guidance

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Start-Up Package

  • Completion of initial regulatory documents
  • Set up and organization of regulatory binder
  • Initial IRB submission
  • DOA creation

Ongoing Regulatory Maintenance

  • Start-Up Package
  • Ongoing IRB communication and submissions
  • DOA and Training log updates
  • Regulatory binder maintenance
  • Study closeout
  • Monitoring visit support for regulatory documents
  • Assistance with Note-to-File writing

Standard Operating Procedures (SOPs)

  • SOP Creation: Creation of SOPs for the site accounting for the site's state regulations.


  • SOP Review: Complete review and overhaul of existing SOPs to account for new research regulations and guidance.

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  • Home
  • Operational Support
  • Regulatory Guidance
  • Compliance Oversight
  • Start-Up Services
  • Financial Management
  • Patient Recruitment
  • Contact Us

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