Pharmaceutical quality management services from j3i Value Added CQA Services Contact j3i on +44 118 977 1736 for international clinical quality management services

Clinical Auditing Services

All clinical research companies need to implement an effective audit programme. j3i can provide expertise in the audit arena and work with existing staff, CROs and contractors to ensure that the audits are conducted efficiently and provide results that evaluate compliance status as well as opportunities for process improvement.

clinical trial investigator site auditsInvestigator Site Audits

  • Routine, ‘for-cause’ and
    pre-inspection
  • UK/International
  • All therapeutic areas
  • Your SOPs/templates or j3i's

CRO auditsCRO Audits

  • Pre-contract assessments and during study audits
  • All types of CROs:
    • Clinical / Data management
    • IVRS
    • Medication packaging & distribution

CQA system and process audits for CROs and pharmaceutical companiesSystem/Process Audits

  • Process-based and systems audits across all areas,including
    • Pharmacovigilance/Drug Safety
    • Investigational Medicinal Product (IMP)
    • Data Management
    • Monitoring activities

Clinical trial data and report auditsData and Report Audits

  • Database audits, including
    Electronic Data Capture systems
  • Data Management processes
  • Clinical Study Reports and other outputs