Quality Framework
The AACT has developed a documented Quality Framework to ensure a harmonized approach to service delivery across its international regional service centres and global network.
Each of the AACT Regional Centers implements this framework and trains its staff on the framework's application to AACT's conduct of clinical trials.
The AACT Quality Framework is based on the ISO9001:2000 approach and standards , and also meets ICH-GCP standards, FDA regulations , and local area regulatory requirements. Further, it incorporates the experience, knowledge base, and best practices of AACT's founding partners.
The benefits of AACT's Quality Framework include higher efficiency, better standardization, less room for error, increased attention to quality, and better control of performance.
The AACT Quality Framework philosophy and approach is dynamic, and focuses on "saying what we do, and doing what we say"
The key elements of the framework include process management, controlled performance and continuous improvement. The framework links similar or related activities into single processes, and clearly defines for each process, the essential inputs (i.e., activities, resources, etc.) to ensure the desired outputs (i.e., results). Further, it documents the assessed risks for each process, and specifies required measures to manage those risks (e.g., standard operating procedures, work instruction manuals, training, etc.).
AACT implements the Quality Framework to control its performance through a dynamic process of planning, doing, checking and acting. Through internal and invited external audits, AACT monitors its performance, thus making continuous improvements to its service continuum.
The AACT Quality Framework is designed on a system of hierarchy that includes processes, standard operating procedures (SOPs), checklists and templates. Each component of the framework is documented in a Quality Manual. Additionally, each staff is trained on the framework in general, as well as in specific aspects directly related to his or her role and job description.
The AACT maintains its Quality Framework through the support of executive management, dedicated staff, client and staff performance feedback, internal and external audits, and annual project performance reviews. While designed to ensure quality service in a harmonized manner, the framework is also designed for flexibility, without compromise to its integrity or validity. In this way, it allows for tailoring at the AACT regional, national, and local levels to accommodate area specific regulations, cultural differences, local organizational diversity, and/or the specific requirements of a study, sponsor, or protocol.