George Clinical quality management experts maintain a quality management structure to facilitate a harmonised approach to the delivery and maintenance of quality and compliance.
George Clinical has a dedicated quality compliance and training team; and an independent Quality Assurance Consultant.
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.
The George Clinical Compliance and Training team are based in our three main offices, Australia, China and India. They provide coverage across the Asia-Pacific region, including: Australia, Korea, Hong Kong, New Zealand, Taiwan and Malaysia.
Periodic compliance reviews and audits, processes and systems, are conducted to ensure compliance and quality at all stages of a trial. All systems and software are fully validated and compliant with regulatory standards.
George Clinical’s Compliance and Training team support the continuous delivery of role-based technical training and standard operating procedure (SOP) curricula.
George Clinical’s quality management activities include:
- Audits and inspections
- Quality metrics
- The development and implementation of standard operating procedures
- Process reviews
- Monitoring oversight (quality visits, document reviews)
- Regulatory requirements & compliance oversight/reviews
- Audits and Inspections
George Clinical provides quality assurance from design to delivery