Quality Management System (QMS) Policy
KLINIK PM
At INKLIDED, we have a Quality Management System based on ISO 9001:2015 and Good Clinical Practice (ICH-GCP R3), and we are committed to excellence in the management and development of clinical studies, ensuring compliance with applicable ethical, regulatory, and quality requirements in all our activities as a participating center and sponsor. Our mission is to promote human-centered clinical and translational research, fostering inclusion, innovation, and scientific integrity, and ensuring that all processes are carried out under recognized standards of quality, transparency, and safety. To fulfill this commitment, INKLIDED aims to:
- To understand and meet the needs and expectations of promoters, researchers, collaborating institutions, participants and health authorities, guaranteeing trust and quality in all services provided.
- Comply with the requirements of ISO 9001, health and data protection legislation, as well as applicable Good Clinical Practices (GCP).
- To guarantee the competence and continuous training of staff, promoting a culture of quality and professional improvement.
- Ensure the traceability, confidentiality, and reliability of the information generated in all phases of the studies.
- Promote continuous improvement of the management system through periodic review of objectives, indicators and results.
- Promote communication, collaboration and transparency with all relevant stakeholders.
- Promote inclusion and equity in participation and development of clinical studies.
The Management of INKLIED assumes responsibility for providing the necessary resources to implement, maintain and continually improve the Quality Management System, ensuring that this policy is understood, applied and reviewed periodically to guarantee its suitability to the foundation's mission.
