Trials@Home consortium has selected Signant Health as a technology vendor for a five-year research project to develop recommendations for decentralised clinical trials (DCTs) implementation in Europe.
By developing and piloting tools, standards, and best practices for DCTs, the project is targeting to redesign clinical trials in the European Union (EU).
The project, which is funded by the EU/EFPIA’s Innovative Medicines Initiative Joint Undertaking (H2020-JTI-IMI2), is divided into six focus areas.
These focus areas will be led by different consortium members who work in commercial, academic, and governmental organisations.
The consortium selected Signant’s SmartSignals randomization and trial supply management (RTSM) and Telemedicine solutions as they can enable complete remote and hybrid clinical trials.
These two solutions also have the ability to integrate with the complex vendor ecosystem to support the clinical study.
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Signant Health chief operating officer Jason Martin said: “We’re proud to be selected for this important research project which will help lay the groundwork for new study conduct options in Europe.
“The recommendations and best practices that we will establish in collaboration with Trials@Home consortium partners will allow medical researchers in Europe to take advantage of exponential digitalization to accelerate and streamline clinical development processes.”
The company will provide a direct-to-patient (DtP) model of its solutions for a proof-of-concept study, which is known as the RADIAL trial.
Across 63 sites in eight countries, the 12-month study aims to recruit 800 subjects with type 2 diabetes.
In the trial, the operational and scientific quality of the complete decentralised and hybrid models will be compared with a conventional study to assess the feasibility of such methods.
The trial is planned to begin this year and results, recommendations, and tools are anticipated in 2024.
In June 2020, Signant Health expanded its mobile patient engagement app, TrialGuide, with integrated virtual visit capabilities.