The Pistoia Alliance Informed Consent blockchain project will demonstrate the value of blockchain technology in underpinning the clinical trial Informed Consent process.

Project Deliverables

A proof-of-concept for a clinical trial Informed Consent ‘service backbone’ based on blockchain technology. This includes delivery of system requirements such that others could adopt or build on the conceptual solution based on their own approach, and learnings for all partners involved.

Why is this important?

Obtaining and revoking consent in clinical trials is a complex process involving multiple stakeholders, documents and transactions in which the creation and maintenance of a secure audit is imperative for regulatory purposes. Blockchain is an emerging technology which enables secure transactions between parties by creating an immutable record of these transactions and storing them as part of a decentralised system.

What will the project achieve?

Demonstrate the value of blockchain technology in the Informed Consent process by creating an end-to-end audit trail in a secure and consistent manner, underpinning a higher level of trust between stakeholders participating in a clinical trial.

How will the project do this?

  • Implement common (multi-pharma) Decentralized ID (DID) management across multiple stakeholders which is agnostic of front-end applications.
  • Present a tamper-proof audit trail for a defined clinical trial Informed Consent process.

Get in touch

If you would like to get involved or have further questions or feedback email the project manager, Richard Norman.