KPE Research Solutions maintains teams of trained and experienced GCP auditors who are extremely competent and equipped to successfully perform the following tasks:

• Ensure that the trial is being conducted according to protocol and applicable regulations, guidelines, and standardsfor on-going studies
• Review training and qualifications of the CRO project team members
• Assess staff workload and turnover rate
• Assess compliance with SOPs
• Assess medical writing capabilities
• Assess vendor qualification, management, and certification programs
• Assess any prior FDA 483s, responses, or Warning Letters, if applicable
• Review computer system procedures and documentation, including those for security, back up, and recovery
• Review QA unit reporting structure, auditing practices, and CAPA procedures