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. 


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