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.Â
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