George Clinical has a dedicated quality compliance and training teamand an independent Quality Assurance Consultant. George Clinical maintains a quality management structure to facilitate a harmonised approach to the delivery and maintenance of quality and compliance. Compliance of study data and documents with ICH-GCP, FDA and local regulatory requirements is verified through reviews by the compliance and training team or audits by the quality assurance function. Compliance and training team representatives are based in the three main offices (Sydney, Beijing and Hyderabad) and provide coverage across the region. Periodic compliance reviews and audits of studies and processes and systems are also conducted as part of the strategy. All systems and software are fully validated and compliant with regulatory standards.
George Clinical employs staff with the required qualifications, knowledge and experience for their intended role and supports this through the delivery of role-based technical training and Standard Operating Procedure (SOP) curricula.