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)
  • Service Provider 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), data management, statistical activities, 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 to the audit
  • Risk-based approach for audit conduct
  • Audit report:
    • Executive summary including an overall assessment
    • Methodology
    • Conduct
    • Audit evidences and 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 adapted to the needs of its Clients and to the challenges of the research.

Request for a proposal