Quality Management System (QMS) is the foundation of any clinical study conduct and is stipulated by the GCP. Ensuring quality in its operations must be of the highest priority to the CRO, and quality control and assurance measures need to be implemented. This approach ensures adherence to regulatory standards, GCP compliance, data integrity, and patient safety. This blog will help you understand and address important questions on why quality matters in clinical trials? and what sponsors need to know about CRO Quality Management System?
A reputable Contract Research Organization (CRO) must be strong in quality management to uphold the highest standards throughout the trial.
A Quality Management System (QMS) is recognized as the basis for all GCP-relevant activities and services of the CRO. A QMS manages the quality of the CRO’s activities including but not limited to standard processes (Standard Operating Procedures, SOP), qualification and continuous training of human resources as well as quality control (QC) and quality assurance (QA).
The following is regarded as critical and needs assessment by the sponsor.
- Implementation of Risk-based Quality Management (RbQM) strategies according to current guidelines and best practices.
- Continuous quality oversight and monitoring of all trial activities to identify and address potential issues and deviations.
- Willingness of the organization to improve by openness to criticism and timely execution of Corrective and Preventive Action (CAPA) plans to address identified issues.
- Efficient document management practices ensure the availability and traceability of essential study documents to be “inspection-ready”.
- Vigilant vendor oversight and maintaining quality standards across outsourced services.
How to access the Quality Management System of a CRO as A Sponsor?
The CRO’s understanding of their Risk-based Quality Management (RbQM) approach.
The CRO should have a functional and well-maintained QMS reflecting the current GCP and guideline landscape.
The CRO should be ready for audits and inspections.
The CROs should have established vendor oversight processes to make sure that quality standards are consistently upheld in outsourced services.
Need help? Contact us for a thorough assessment of the CRO you’re planning to select.
Autor: Dr. Christoph Ortland, October 2023
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