The company's RTSM and telemedicine solutions will play an instrumental role in supporting decentralized and hybrid modes of clinical trial design and conduct
PHILADELPHIA, Jan. 19, 2022 /PRNewswire/ -- Signant Health, the leader in evidence generation for modern clinical trials, announced today that it has been selected as a technology vendor for the Trials@Home consortium. This landmark, five-year research project aims to reshape clinical trials in the European Union (EU) by developing and piloting standards, tools, and best practices for decentralized clinical trials (DCTs). Funded by the EU/EFPIA's Innovative Medicines Initiative [2] Joint Undertaking (H2020-JTI-IMI2), the project is split into six focus areas led by different consortium members who span academic, commercial, and governmental organizations.
As the only member selected to provide technology solutions for two of the consortium's Pilot Basic Building Blocks categories, Signant will deliver a direct-to-patient (DtP) model of its industry-leading Randomization and Trial Supply Management (RTSM) solution as well as its Telemedicine platform for a 12-month, pan-EU proof-of-concept study, called the RADIAL trial.
This trial aims to include 800 patients with type 2 diabetes across 63 sites in eight countries. The RADIAL trial will compare the scientific and operational quality of fully decentralized and hybrid models to a conventional trial in order to evaluate the feasibility of such approaches. Results will help define legal, regulatory, ethical, and operational challenges and corresponding solutions, as well as be incorporated into recommendations for technologies that underpin successful DCTs.
The Trials@Home consortium selected Signant's SmartSignals RTSM and Telemedicine solutions based on their ability to facilitate fully remote and hybrid clinical trials as well as to integrate with the complex vendor ecosystem supporting the study. Additional award criteria included the company's clinical research experience in Europe and operational successes in high-profile, decentralized COVID-19 clinical trials.
"We're proud to be selected for this important research project which will help lay the groundwork for new study conduct options in Europe," said Jason Martin, Signant's chief operating officer. "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."
"DCTs have been widely recognized as a vehicle to address many of today's most pressing challenges in clinical development in Europe," added Rebecca Jackson, senior manager, clinical R&D innovation IT at Janssen and Trial@Home's tech focus area co-lead alongside Sten Hanke, associate professor at Joanneum. "Benefits include the potential for recruiting and retaining representative participant populations, expanding trial access and diversity of participants, and improving speed and efficiency of clinical trials. Carefully selected research partners like Signant play a critical role in the development of new standards for clinical trial design and conduct that will ultimately help eliminate traditional barriers to research participation."
The RADIAL trial is scheduled to launch in 2022, with results, recommendations, and tools expected in 2024.
About Signant Health
Signant Health is the evidence generation company. We are focused on leveraging software, deep therapeutic and scientific knowledge, and operational expertise to consistently capture, aggregate, and reveal quality evidence for clinical studies across traditional, virtual, and hybrid trial models. For more than 20 years, over 400 sponsors and CROs of all sizes - including all Top 20 pharma - have trusted Signant solutions for remote and site-based eCOA, eConsent, RTSM, supply chain management, and data quality analytics. Learn more at www.signanthealth.com.
Contact:
Heather Bilinski
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