Services
Aurelia Quality Assurance Pty Ltd provides the following Clinical Research Quality Audit service to the pharmaceutical industry.:
GCP Clinical AuditsClinical trial audits on behalf of the sponsor including investigational site inspection, according to protocol, GCP and local/international regulatory guidelines (including FDA, TGA and EU standards) |
Trust |
Clinical Laboratory AuditsPre-selection qualification visits, and in process inspection of central or local laboratories. |
Reliability |
Service providers inspectionsSub-contractor pre-selection evaluation or in-progress assessment of contract clinical service providers i.e. Clinical CROs, drug labeling and distribution providers, Phase I facilities. |
Knowledge |
Essential Document ReviewInspection of “essential documents” for compliance with ICH GCP, and local or international guidelines (FDA, TGA, EU): IDB, clinical protocol, Patient Information Sheet. In addition, Aurelia QA can support sponsors by providing local essential document review prior to activation of a site (i.e. review ethics letters, investigator CVs, Form FDA 1572, TGA CTN acknowledgement). |
Professional |
Quality Management System SupportDevelopment and review of clinical or quality system standard operating procedures (SOPs). |
Technology |