Evaluating the challenges and benefits of fully decentralized and hybrid clinical trials

A pan-European interventional study to enrol Diabetes Mellitus (DM) patients

The RADIAL concept study aims to generate delivering scientific evidence and data on the benefits and challenges of running a DCT Clinpal is the core platform for this in a 3-arm (conventional, hybrid, remote) clinical trial in 6 European countries. The platform then orchestrates all ‘actors’ and manages pre-screening, learning management, informed consent and data collection for the study, integrating with the RADIAL study app a bespoke adaptation of the Clinpal standard app.

A unified system
With a single database, the Clinpal system provides:

Pre-Screener
Patient Disposition
Patient Identification
E-Learning
Setup of telemedicine solution
eInformed Consent
Qualified electronic signature (eIDAS)
Diary, Data Entry, Reporting
Bar code scanning of labkits
Glucometer integration
Smart Injector Pen setup
Patient entered reports and diaries ePROs (5x)
EDC
Engagement and Reminders
Patient data return

The research leading to these results has received support from the EU/EFPIA Innovative Medicines Initiative [2] Joint Undertaking (H2020-JTI-IMI2) Trials@Home grant n° 831458.