Clinical Auditing

FormaliS conducts audits of clinical studies to check compliance with regulations and protocols, as well as to assess the reliability and quality of the data.

Activity:

  • Feasibility audits
  • Site audits
  • System audits
  • Report audits

Scope:

  • Clinical Studies from Phase I to IV
  • All Therapeutic Areas
  • Medical Devices
  • Biotech Products

Standards:

  • ICH GCP
  • FDA Requirements
  • EU Directives and Guidelines
  • Local Clinical Trial Regulations