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Blockchain-enabled quality by design system for clinical trials.

Reza Vatankhah Barenji1, Reza Ebrahimi Hariry2

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

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|December 22, 2025
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Summary
This summary is machine-generated.

Blockchain technology enhances clinical trial quality by design (QbD) by improving data integrity and participant safety. This secure, distributed approach boosts data consistency and process verification for better trial management.

Keywords:
PDCAblockchain technologyclinical trialsdrug developmentquality by design

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Area of Science:

  • Clinical Research
  • Data Management
  • Information Technology

Background:

  • Quality by Design (QbD) is crucial for clinical trial integrity.
  • Current data management in trials faces challenges in integrity and transparency.
  • Blockchain technology offers a novel solution for secure, distributed data handling.

Purpose of the Study:

  • To develop and evaluate a blockchain-enabled Quality by Design (QbD) architecture for clinical trials.
  • To enhance data integrity, participant safety, and traceability within clinical trial processes.
  • To demonstrate the feasibility and scalability of blockchain integration in clinical data management.

Main Methods:

  • Developed a blockchain-enabled QbD architecture.
  • Implemented a prototype using Hyperledger Fabric.
  • Evaluated the system's applicability using pilot clinical trial data.

Main Results:

  • The architecture facilitated immutable data exchange and enhanced traceability of QbD activities.
  • Secure collaboration among stakeholders was supported.
  • Improved data consistency and enabled automated verification of trial processes.

Conclusions:

  • Blockchain technology effectively enhances QbD implementation in clinical trials.
  • The proposed architecture improves data integration, transparency, and safety monitoring.
  • This model offers a feasible and scalable solution for future clinical data management systems.