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Sistema de calidad por diseño habilitado por blockchain para ensayos clínicos

Reza Vatankhah Barenji¹, Reza Ebrahimi Hariry²

¹Department of Engineering, School of Science and Technology, Nottingham Trent University, Nottingham, United Kingdom.

Frontiers in medicine

|December 22, 2025

Abstracto

Introduction:

Blockchain technology offers a secure and distributed approach to data management that can strengthen the Quality by Design (QbD) framework in clinical trials. Integrating blockchain with QbD can enhance data integrity and promote participant safety.

Methods:

A blockchain-enabled QbD architecture was developed to support systematic quality improvement in clinical trials. The interactions among its components and peers were described, and a prototype was implemented using Hyperledger Fabric. Data from a pilot clinical trial were used to evaluate its applicability.

Results:

The prototype demonstrated that the proposed architecture efficiently facilitates immutable data exchange, enhances traceability among QbD activities, and supports secure collaboration between stakeholders. The system improved data consistency and enabled automated verification of trial processes.

Discussion:

This study shows that blockchain technology can effectively enhance QbD implementation in clinical trials by improving data integration, transparency, and safety monitoring. The proposed architecture provides a feasible and scalable model for future clinical data management systems.

Palabras clave:

PDCA tecnología blockchain ensayos clínicos desarrollo de fármacos calidad por diseño

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