This year GCT successfully passed 2 Sponsor audits. They were performed by independent auditors employed by the sponsor companies. From GCT side both audits were led by GCT QA expert and director — Vladimir Seredyuk, MD. Audits included review of project-specific topics, the company’s general procedures, capabilities, and the organizational structure. Neither audit yielded any critical or major findings.
The first audit was performed at the end of January in connection with the observational pediatric study that GCT is running in Europe since 2015. Lasting three days, it covered a broad spectrum of activities including: Staff Qualification and Training procedures, Quality Assurance, Project Management, Regulatory Affairs, Site Monitoring, Data Security/Backup practice, IT department policies, and GCT documentation practices.
The second audit occurred this past March in preparation of initiation of a phase IV trial in infectious disease, which is to be conducted by GCT at several sites in Russia. A review of study-related IT inventory, management procedures for handling Medicinal Product and Lab Samples was performed. The auditor also focused on the GCT’s Standard Operational Procedures (SOPs) and study specific documentation review.
The lack of audit findings confirmed our company as a strong global CRO-partner with on the ground expertise in different locations.