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 that when built and implemented correctly, creates an exceptional framework for success. However, conducting 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 trial landscape, and what was once a challenge has now become the “gold standard” for supporting clinical trials in the region.
Understanding the challenge
The feedback we received is not unique to Medable. Across the industry, Japan has been identified as a region where sponsors frequently receive feedback for improvement.
These challenges include:
- Technology that doesn’t function as expected on Japanese devices.
- Help desk support that doesn’t meet expectations.
- Training materials not adequately tailored to Japanese sites and patients.
- Cultural nuances that aren’t fully understood or respected.
As one study team member shared, “there’s a cultural aspect where [sites] may feel embarrassed if a patient is present and there’s a technology issue.”
Breaking down barriers
Our first key realization was that traditional communication channels were contributing to the problem. Normally, we may communicate with a global study team who relayed information to the direct team. When issues arose, they were escalated through this chain, often reaching us as complaints instead of opportunities for collaboration.
To resolve this, we established direct communication with the Japanese team and initiated weekly calls to better understand their challenges. This open, direct dialogue enabled us to hear unfiltered feedback, identify cultural nuances that were affecting the trial experience, and empower the Japanese team.
Creating a specific approach
Based on the invaluable insights we gathered, we developed a tailored strategy for our subsequent studies in Japan. We recognized that Japan’s clinical trial requirements require all site materials be availablein Japanese. Thus, we partnered with RWS, a leading localization organization, to ensure accurate translations well in advance of the “first patient in” (FPI) date. Furthermore, Japanese regulations require devices to have specific “J-marking” certifications. We sourced Japan-specific devices with the proper certifications, conducted end-user testing on those exact devices, and ensured everything was fully operational before deployment.
We also revamped our onboarding approach to ensure it was culturally sensitive and effective. This included providing site user guides in Japanese, creating one-page summaries of required activities, offering live and recorded training sessions for sites and Clinical Research Associates (CRAs), developing demo videos in both English and Japanese to walk teams through the entire trial workflow, and establishing a 24/7 help desk staffed with Japanese-speaking support agents trained in cultural sensitivity. Lastly, we implemented a strict “design freeze” well before launch to avoid last-minute changes that could impact localization or site readiness.
Results that speak volumes
The changes resulted in both immediate and impactful results:
- We surpassed the forecasted “first patient In” (FPI) date.
- Help desk tickets dropped to an all-time low for the study.
- Site and patient adherence rates exceeded 90%, including eCOA adherence.
- First-call resolution rates soared to over 90%, meaning most issues were resolved on the first interaction.
The “gold standard” for clinical trials in Japan
Perhaps the most meaningful outcome of all was the feedback we received from our Japanese team. They requested that our recommendations be standardized across all eCOA partners for every study in Japan. What began as a set of solutions to address immediate challenges has now become the benchmark for clinical trial support in the region.
