Clinical trial participants are a vital part of drug development
research and there are many rules to help and ensure the safety and
ethics of clinical trials. Managing patient safety during clinical
trials is a critical component throughout the drug development
life-cycle. As the first step towards ensuring patient safety, all the
involved parties in drug development need to be respectful and
responsive towards patient’s needs, comfort, and preferences i.e.
ensuring a patient-centric approach. In this paper blockchain technology
is embedded in the Quality by Design (QbD) systematic approach to boost
data integrity among the activities, and to promote participants’ safety
in clinical trials. First, blockchain-enabled QbD architecture is
proposed and the interactions among the enablers and peers are
highlighted. Then, a prototype of the proposed architecture is developed
and the data of a pilot trial is used to justify the applicability of
the architecture. The results showed that the proposed architecture is
efficient, and hence it is feasible to adopt into a clinical trial.