3H Medi and Thread partner to boost decentralized trials in Japan
3H Medi Solution, which houses divisions aimed at both English- and Japanese-speaking customers, announced that it had partnered with Thread to expand on its decentralized clinical trial (DCT) research capabilities and improve access to clinical research for patients in Japan.
3H Medi possesses recruitment, home visit support and overall clinical study delivery capabilities, and will supplement these with Thread’s technology platform and consulting services.
Thread operates by aiding pharma companies and clinical research organizations (CROs) to design, operate, and scale research studies and electronic clinical outcome assessment (eCOA) programs for participants, sites, and study teams.
Clinical trial delivery
The companies outlined that the clinical trial delivery model in Japan is changing, with the COVID-19 pandemic occasioning greater reliance on digital models, as seen around the world.
In particular, the partners outlined guidelines released by Japan’s Pharmaceuticals and medical Devices Agency (PMDA), which described the ways in which digital tools could facilitate clinical trials in Japan. The guidelines focus on drawing attention to the fact electronic-informed consent in clinical trials in the country will be an option soon, allowing for the acceleration of subject enrollment.
In terms of what additional tools will be offered to sponsors through the partnership, 3H Medi stated that it will allow for clients to engage consultants for patient-centered design support, operational service delivery and technology platform support for DCT and eCOA solutions.
Thread's DCT platform
The platform referred to is Thread’s DCT platform, which the company states is an end-to-end solution that operates through the lifecycle of a study. The platform operates with features across four sections, Design, Enroll, Operate, and Access – with specific modules for each part of the process.
Due to the remote access to the platform, principal investigators, study coordinators, and home health nurses are able to log in through a web-enabled portal. Once in the portal, they are able to access specific participant profiles, review electronic Case Report Forms (eCRFs), and verify that data.
In addition, Thread possesses a participant app containing tools to maintain participant engagement throughout the course of a study. This enables the collection of data, survey completion, and virtual visits.
At the beginning of this year, Thread announced that Sanofi had selected it as its global DCTs provider, as part of a five-year partnership. The deal made Thread Sanofi’s sole collaborator under its ‘Integrated Patient Platform’ to deliver DCTs and eCOA technology.
