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DECENTRALIZED TRIALS

The Decentralized Trials projects portfolio aims to transform the clinical trials industry by leveraging cutting-edge technology to streamline and digitalize the trials process using Verifiable Credentials, Decentralized Identifiers (DID), and product digital twins.

A decentralized and interoperable architecture can enable shorter, more efficient, and more accessible participation in clinical trials while improving monitoring and reporting, all of which can help reduce the time it takes for a life-saving product to reach the ones in need.

The key components of this project portfolio include but are not limited to PharmaLedger Project legacy use cases. 

In the Sandbox Ideas and Project Incubation phases are: eConsent, eEnrollment/eRecruitment, and IoT Medical Devices & Personalized Medicines.

Providing patients with a trusted and dynamic consent process for digital trial enrollment can make it easier for patients and providers to access clinical trials, while also reducing the administrative burden on trial sponsors.

We believe that Decentralized Trials have the potential to revolutionize the clinical trials industry, and we are committed to working with our members and partners to make this vision a reality. Our goal is to create a more patient-centric, efficient, and secure trials process that benefits everyone involved and connects to existing solutions.

PROJECTS PORTFOLIO

A secure and trusted health dataspace for clinical trial data management driven by real-time consent and Real World Data (RWD) usage.

eCONSENT

Dynamic and permissioned data acquisition for trial participants, enabling automation of informed consent and trial processes.

Trial Participant

Consent driven data

Re-consent or withdrawal
notified near real-time

Verifiable data

Data Ownership

Patient empowerment

Patient feedback &
continuous remote
monitoring

Voluntary provision of data
for secondary usage

Medical & Consumer
oriented devices as input
source

Clinical Site

Reduced time required
for documentation review

Consent driven data access & processing

Auditability and traceability of data, PROMs, PREMs & Evidences

Dynamic acquisition &
processing of devices` data and evidence generation

RWD collection for research or clinical practice purposes Generate personalized patient feedback

Sponsor / Clinical
Research Associate

Reduced time required for documentation review

Confidence in use of correct versions and data

Ensure patient safety
Simplified management
Site / country / language specific versions

Auditability and traceability of data

Grants transparent &
overview of permissioned data

Laboratory

Compliance demonstration
following consent provided

Real-time changes in
sample testing following
consent withdrawal

Faster end-to-end trial cycle times

Regulatory Authority /
Ethics Committee

Confidence in informed
consent being obtained and recorded as per GCP, using correct versions

Immediate notification of new versions or issues

Real-time approval of new versions (time saving)

Data Models for Policy
Making

eEnrollment / eRecruitment

A multi-stakeholder platform which enables Patients, Providers, Sponsors, and Clinical Sites to participate in an industry-wide utility service that is unbiased and patient-centric in matching trials with participants.

To unlock the potential of patient-initiated approaches, it must be easier to find trials

  • A neutral, sponsor agnostic utility to help patients (and their physicians) find suitable clinical trials

  • Any sponsor (industry or academic) and any patient or physician equal access to the matching utility

  • Potential matches to a clinical trial’s pre-screening criteria, are referred to clinical sites for further evaluation

  • Patients are in control of their data

  • Patients have increased visibility into how their data is used

  • A blockchain ledger maintains trust between all parties

  • Redundant workflows are eliminated

  • Patient data privacy requirements are met (GDPR, etc.)

  • Full provenance of matching transactions are anchored to the blockchain

IoT Medical Devices &
Personalized Medicine

This project’s objective is to provide dynamic acquisition and processing of data from patient Real World Data (RWD) sources to accelerate clinical development and enable Remote Patient Monitoring (RPM)​. This introduces new rights for patient data ownership and portability, and leverages dynamic consent while using device-generated data in compliance with data privacy regulations. 

EXPECTED OUTCOMES

  • Patients exchange their data securely and seamlessly

  • Dynamic acquisition and processing of data from devices

  • Remote patient monitoring

  • Patient-centric trusted environment for decentralized applications

  • Leverages RWE for research & Evidence Creation

  • Value-Based health delivery in clinical practice