Safe and secure digital interactions between stakeholders participating
in clinical trials can increase
efficiencies and reduce costs

In collaboration with AstraZeneca, Novartis, and Pistoia Alliance, Spherity has worked on a use case to enable an interactive, engaging, and trust-based Informed Consent Form (ICF) experience for patients. The project demonstrates the value of digital identity technologies in the ICF process and ensures efficiencies in the drug development lifecycle. 

For every change in a clinical study, participants must go through a new ICF process, which is primarily paper-based and requires multiple-party interactions. Since studies can run over the years, this results in a continuously repeating series of ICFs and high administrative costs. With the Spherity Cloud Identity Wallet, every participant gets a digital identity to manage their ICF signatures and interact with each other in a trusted and verifiable way.

The Solution

The core principle of the solution is based on an identity layer built on Decentralized Identifiers (DIDs) and Verifiable Credentials (VCs), which enable to build up a trusted network and puts patients in control of their ICF journey. Through DIDs, every participating actor gets a unique digital identity, verifiable for third parties, and can be anonymized. Verifiable Credentials represent a block of verifiable data attributes cryptographically bound to the owner’s identities, the issuer, and optionally to other parties. This allows identity subjects, credential issuers, or verifiers to interact in a tamper-evident and privacy-preserving manner.

Participants and doctors can access their Cloud Identity Wallet to manage ICF signatures through a web application, while sponsors or the ethics committee can integrate their Cloud Identity Wallet into existing business applications to ensure a seamless process managing ICFs. Wallets are the only add-on technology to the existing informed consent process integrated via API easily, allowing actors to sign and revoke ICFs digitally.

Benefits

  • Transparent and efficient ICF processing for patients 
  • Users are in greater control of their data 
  • Tamper-proof data exchange
  • Digitally managed administrative efforts for sponsors, participants, and doctors
  • Better outcomes of clinical trials resulting from the less amount of time spent on paperwork and low cancelation rates

Features

  • Real-time audit module for ICF documentation
  • API integration for involved actors to sign and revoke ICFs digitally

PILOT PROFILE

PistoiaAlliance_compact_colour_RGB-e1544552222337

In partnership with

AstraZeneca

Novartis

Project Scope
Spherity Cloud Identity Wallet

Industry
Pharmaceutical

Country/ Continent
Europe

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