ISO 9001 Quality Management System
Ethic Medikal Araştırma Ltd. Şti. provides high-quality clinical research services to all its stakeholders, including medical device and pharmaceutical companies, contract research organisations (CROs), investigators, research teams, and laboratory and imaging centres.
Our company is committed to establishing and maintaining a Quality Management System aligned with the scope of its operations, strategic direction and corporate objectives. In this context, we undertake to meet — and where possible exceed — customer expectations and requirements, and to ensure full compliance with local and international regulatory requirements, ICH-GCP (Good Clinical Practice) principles and relevant legislation. We also aim to provide the necessary framework for the establishment, implementation and review of quality objectives.
Core Principles
We continuously improve our service quality and provide timely, reliable and accurate services to meet the expectations and needs of sponsors, investigators and other stakeholders. We systematically evaluate feedback and undertake activities to enhance satisfaction levels.
We ensure full compliance with the ISO 9001 Quality Management System Standard, local and international regulations, ethical rules and ICH-GCP standards in all our processes; we accept participant safety as a top priority.
We safeguard the accuracy, integrity and traceability of clinical research data in line with ALCOA+ principles. We protect all data and participant information in accordance with confidentiality principles.
In cooperation with laboratories, imaging centres and other service providers, we observe quality standards and carry out regular evaluation and monitoring processes.
Through process-based management and risk-based thinking, we develop preventive systems and safeguard the continuity, effectiveness and quality of our services.
We regularly review the suitability, adequacy and effectiveness of our Quality Management System and support continual improvement through internal audits, corrective actions and improvement activities.
We organise ongoing training to raise our employees' quality awareness, GCP and regulatory awareness, and support the development of their competencies.
We conduct all our activities in adherence to ethical principles, and act within the framework of scientific accuracy and professional responsibility.
Ethic Medikal Araştırma Ltd. Şti. is committed to delivering services in all its activities in line with this quality policy, prioritising participant safety, data integrity, and compliance with ethical principles and legal requirements. Our organisation aims to meet the expectations of customers and relevant parties, achieve its quality objectives, support the development of its employees, and ensure sustainable success by continuously improving the effectiveness of its Quality Management System.
Top management supports the communication, understanding, implementation and continuity of this quality policy within the organisation and ensures the provision of the necessary resources.
