Quality Management System (QMS)
- AGADA operates under a robust Quality Management System (QMS), designed to manage processes, policies, and procedures in a controlled and risk-based manner across all clinical operations. Our QMS ensures consistency, traceability, and continual improvement.
Oversight of Clinical Deliverables
- All clinical plans, reports, presentations, data transfers, and raw data/statistical outputs undergo QA review and approval prior to release.
Culture of Integrity and Accountability
- Our team is committed to a culture of integrity and accountability. AGADA develops and adheres to rigorous internal standards that support validated, effective practices for data collection, documentation, and reporting.
Protocol Adherence and Compliance
- Our quality systems are aligned with agreed trial protocols, ensuring operational compliance and regulatory adherence throughout the trial or clinical services.
Equipment Management
- All laboratory equipment used in clinical trials is selected, installed, validated, maintained, and decommissioned in accordance with documented procedures and manufacturer specifications.
Quality Event Monitoring
- We maintain robust systems to detect, report, and investigate quality events. Corrective and preventive actions (CAPAs) are implemented to resolve issues and prevent recurrence, ensuring continuous quality and safety oversight.
Quality Control & Assurance Processes
- Rigorous QC procedures are in place to verify compliance with SOPs and to ensure the accuracy, completeness, and integrity of clinical data. All outputs undergo independent QA review to confirm adherence to established standards prior to final delivery of data or services.
