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  • Athinon 6, Sea View Point, Suite 201, 7573 Anafotida, Larnaca, Cyprus
CY +357 99 272782 | GR +30 697 728 9821

Quality Assurance

Commitment to Quality, Compliance & Continuous Improvement

At Abrazo Research, quality is integral to every aspect of our clinical research services. We are committed to supporting the conduct of clinical trials in accordance with applicable regulatory requirements, Good Clinical Practice (ICH-GCP), relevant quality standards, and established procedures.

Through a structured, risk-based approach to quality management, we support the consistent implementation of processes, the integrity of clinical trial documentation, and the timely identification and resolution of quality issues. Our focus is on maintaining compliance, promoting continuous improvement, and providing sponsors and partner CROs with confidence in the quality and reliability of our services.

Our Quality Assurance Services

  • ✔ Standard Operating Procedures (SOPs) and Quality Documentation

    We support the development, implementation, maintenance, and review of SOPs, work instructions, and other controlled documents to promote consistent, high-quality, and compliant clinical research processes, in alignment with applicable regulatory requirements and relevant standards, including ICH-GCP (Good Clinical Practice) and ISO 14155 (Clinical Investigation of Medical Devices for Human Subjects — Good Clinical Practice).

  • ✔ Audits and Quality Oversight

    We support quality oversight activities, including site, vendor, and Trial Master File (TMF) audits, as applicable to the agreed scope of services. These activities help assess compliance, identify gaps, and support the timely follow-up of audit findings.

  • ✔ Corrective and Preventive Actions (CAPA)

    We support the documentation, investigation, tracking, and follow-up of corrective and preventive actions to address identified quality issues and help prevent recurrence.

  • ✔ Deviation and Issue Management

    We support the identification, documentation, assessment, and tracking of protocol deviations, procedural deviations, and other quality issues, facilitating appropriate escalation and resolution.

  • ✔ Inspection Readiness

    We help maintain inspection readiness through essential document oversight, documentation checks, action tracking, and follow-up of outstanding items to support the availability and completeness of clinical trial records.

  • ✔ Training and Competency Management

    We support the coordination and documentation of relevant training to help ensure that personnel understand applicable procedures, study requirements, and their assigned responsibilities.