Services - GCP

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Clinical Research Organization (CRO) GCP Audits

• Tour facility, including IT and document storage facilities

• Review SOPs to ensure procedures and systems used in the conduct of clinical trials are in compliance with applicable guidelines and regulations. This includes SOPs for:

• Assess compliance with SOPs

• Assess vendor qualification, management, and certification programs

• Review qualifications and training of the CRO project team members

• Assess staff workload and turnover rate

• Review Quality Management System, including Quality Manual and Policy

• Review computer system procedures and documentation, including those for security, back up, and recovery

• Review QA unit reporting structure, auditing practices, and CAPA procedures

• Assess any prior FDA 483s, responses, or Warning Letters, if applicable

• Assess medical writing capabilities

• For on-going studies, ensure that the trial is being performed according to protocol and applicable regulations, guidelines, and standards