Below are examples of the some of the projects that we have experience of:

  • Vendor audits – single and multiple sites involved across all stages of Clinical Development
  • GCP site audits – Investigator, Sponsor and CRO
  • Department audits – EG Data Management, Report Writing, Quality Assurance, Quality Control, Information Technology, Archiving
  • Clinical Laboratory audits
  • Documentation and information retention and storage audits
  • Local and Global process audits – EG Protocol Deviations and Violations, Reporting Serious non-compliance, Data Management, CAPA management, Clinical Study Report creation and review
  • Business Continuity audits
  • Disaster Recovery audits
  • Due diligence audits
  • Computer System Validation audits
  • GcLP audits
  • Regulatory Inspection readiness
  • Regulatory Inspection follow-up and inspection response preparation
  • CAPA system set up and management
  • CAPA planning
  • Mock Inspections

We welcome enquiries from new or existing clients so please contact us to find out how we can help with your project.