CSL Behring conducts clinical trials in accordance with the current Guideline for Good Clinical Practice (GCP) of the International Conference on Harmonisation (ICH). GCP is an international ethical and scientific quality standard for designing, conducting and reporting studies that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and well-being of study subjects are protected and that the clinical trial data are credible.
CSL Behring’s Quality Management System consists of an independent Quality Assurance function along with a Quality Operations group that is a part of the clinical development organisation. Together, the two groups provide the foundation for a risk-based, proactively managed Quality System across Global Clinical Development that helps to ensure regulated clinical trial activities are:
- Conducted with a high level of quality;
- Conducted according to regulatory requirements;
- Consistent with industry best practices;
These objectives are achieved through:
- Maintenance of a robust set of written standard operating procedures (SOPs) with staff adequately trained against them;
- A compliance monitoring program to ensure adherence to the SOPs and drive inspection readiness;
- A well-defined Corrective Action/Preventive Action (CAPA) management process that promotes a systematic approach to dealing with critical/major issues and enabling study teams to effectively apply real-time lessons learned;
- Execution of audits on our investigative sites, vendors, and internal processes/systems.