When talking to customers conducting their first multi-country trial, we sometimes liken clinical trials to spider webs. Just as a garden spider’s web differs from a black widow’s, clinical trials follow unique patterns in every region. Each country comes with its own set of rules, ethical standards, approval processes, and data privacy laws. Cultural factors also play a crucial role in how patients are recruited and understand Clinical trials, requiring sensitive communication and a deep respect for participants’ needs.

In Japan, these regulatory and cultural intricacies form a complex ‘web,’ with anchor points and structural requirements that, when understood and implemented correctly, create a framework for success. However, conducting Clinical trials in Japan has historically posed challenges for Sponsors and Contract Research Organizations (CROs). When we first entered the region, one Sponsor consistently cited issues with eCOA solutions and site and patient support, not fully adapting to Japan’s unique requirements. This feedback, combined with our own experiences on the ground, revealed a clear need for improvement.

Today, we can proudly say that the solutions we put in place have transformed Japan’s Clinical trial landscape, and what was once a challenge has now become the “gold standard” for supporting Clinical trials in the region.

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Medable’s 2024 was a year of exceeding key milestones and helping our customers reach new heights.

Take a look at the difference Medable has made with our year-end impact report.

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A top-10 pharmaceutical company was looking to reduce the amount of administrative burden on their clinical trial sites and themselves.  The sponsor sought to find a vendor that could use one eConsent system to manage paper and electronic consent.  Additionally, they sought to use the central eConsent system to populate the clinical trial sites’ IRB and EDC systems,  as well as some internal systems.

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