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Audit

What we can do

Internal audit

  • Outsourcing/outsourcing of operations (including systems and organizations)

  • Monitoring (including handling of safety information)

  • Summary report (including DM/analysis)

  • Record preservation

  • Other necessary information

Medical institution audit

  • Clinical trial system (trial implementation system, SOP creation, revision/abolition and operation, management of testing equipment)

  • Institutional Review Board

  • Consistency between source materials and case report forms

  • Storage and management of investigational drugs, investigational devices, or investigational products

  • Management of specimens for testing/inspection

  • Record preservation

  • Contract documents with clinical trial facility support organization

Contractual Achievements

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