Clinical Audits

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Clinical Audits

Audits and quality controls are part of clinical researches continuous improvement. They take place before, during and after the study.

Sunnikan performs all type of clinical research audits: Clinical Trials on medicinal products, Clinical Investigation (medical devices), Performance Studies (in-vitro diagnosis medical devices), RIPH1, RIPH2, RIPH3:

  • System audit
  • Investigation site audit (routine, for-cause)
  • Sub-contractor audit
    • qualification, follow-up, routine, for-cause
    • CRO, CSO, CDMO, central laboratory
  • Preparation for GCP inspections (mock inspection)
  • Process audit: biological samples management, experimental products management, project management, documentation management (TMF), etc.
  • Quality controls: TMF, clinical study report

Our methodology:

  • Definition of your needs to prepare a tailored proposal / contract
  • Audit preparation: kick-off meeting and transmission of documents relevant for the audit
  • Risk-based approach for audit conduct
  • Audit report:
    • Executive summary including an overall assessment
    • Methodology
    • Conduct
  • Audit evidences:
    • Findings (with criticality assessment: minor, major, critical)
    • On request: improvement suggestions
  • Preparation and review of the CAPA Plan (as applicable).

Sunnikan draws up audit programs that are perfectly adapted to the needs of its Clients and to the research’s end goals.

Request for a proposal