GCP and GcLP - system and study audits

• Investigational sites
• Sponsors (e.g. clinical operation department)
• Contract Research Organizations (CROs)
• Suppliers and distributors
• Trial Master Files (TMFs)
• Documents (study protocol, clinical study report,
  patient information, informed consent form etc.)
• Analytical and clinical laboratories

Standard Operating Procedures (SOPs)

• Review of SOPs
• Gap analysis
• Writing of SOPs

Consultancy & Support

• Audits:
• Preparedness for audits by sponsors and follow-up
• Corrective and preventive actions (CAPAs)
• Audit programs
• Inspections:
• Preparedness for inspections by competent authorities
• Follow-up of inspection findings
• Guidance for
• ICH GCP
• Implementation and maintenance of a GCP-compliant quality system
• Quality assurance
• Quality control
• Clinical trial planning and conduct
• Training
• ICH GCP
• Regulatory requirements
• Company SOPs
• Development or review of study protocols, study report, informed consent forms
• Development of training documentation
• TMF set-up, maintenance and quality control
• Monitoring or co-monitoring of clinical trial sites