Japan is quickly becoming one of the most important countries in Asia for clinical research, not just because of its strong healthcare system and regulatory structure, but also due to its growing focus on innovation and patient-centered studies. But running a successful trial in Japan takes more than just choosing a country; it requires selecting the right sites and investigators. The quality of your site selection can make or break a study here, where patient access, investigator motivation, and institutional processes can vary widely. 

In this article, we’ll take a closer look at Japan’s clinical trial site landscape, share insights on working with investigators, explore some of the challenges sponsors often face, and offer guidance on how to engage with the right sites more effectively.

Also, we explore why Japan is becoming a key part of global clinical trials and what makes its sites increasingly valuable for international sponsors. 

Japan Clinical Trial Scenario & Landscape

Why Consider Japan for Clinical Trials

Japan offers a compelling environment for clinical trials, thanks to its strong regulatory framework, advanced healthcare infrastructure, and commitment to R&D. As a member of the ICH, Japan aligns with global regulatory standards, making it easier for sponsors to integrate it into multiregional studies.

Japan remains a key player in global clinical research, with consistent trial activity spanning various therapeutic areas. Although numbers vary, it’s estimated that approximately 1,500 clinical trials are actively underway in Japan at any given moment.

The country’s highly developed healthcare system supports efficient trial conduct, while experienced investigators and GCP-compliant sites ensure data quality. Importantly, Japan’s aging population and high burden of chronic diseases create strong therapeutic opportunities, particularly in oncology, cardiology, neurology, and rare diseases.

For sponsors seeking high-quality data, regulatory alignment, and access to a strategically important patient population, Japan is an increasingly valuable part of global clinical development.

Clinical Trial Statistics in Japan

Japan continues to maintain a strong presence in the global clinical research space, supported by steady trial activity across therapeutic areas. While real-time figures fluctuate, current estimates suggest that around 1,500 clinical trials are actively ongoing in Japan at any given time.

Historically, Japan has conducted over 10,000 clinical trials, reflecting its long-standing commitment to clinical research and regulatory rigor. These studies span from early-phase exploratory trials to large-scale multiregional programs, especially in therapeutic areas like oncology, cardiology, CNS, and metabolic diseases.

Key trends observed in recent years include:

• A steady year-on-year increase in trials involving global sponsors, particularly from the U.S. and Europe
• Growing inclusion of Japanese sites in multiregional clinical trials (MRCTs)
• A shift toward more complex and targeted therapies, with increased activity in rare diseases and personalized medicine
• Rising participation from academic medical centers and SMOs, improving operational scalability and efficiency

Why Sponsors Should Consider Japan Sites as Well

For sponsors already running global trials—particularly in regions such as the U.S. or Europe—expanding into Japan isn’t merely about broadening geographic reach. It’s a strategic decision that aligns with key regulatory, operational, and scientific goals.

One key challenge is the difficulty of enrolling Japanese patients outside Japan. Global trials often struggle to meet Japan-specific data expectations without involving local sites. Including Japanese trial sites from the start helps overcome this gap.

Here’s why it matters:

• PMDA expects ethnically relevant data for Japanese submissions. Trials that lack domestic Japanese data may face longer review timelines or require separate bridging studies.
• Including Japanese sites early supports smoother regulatory discussions and demonstrates proactive alignment with local requirements.
• It reduces the need for separate Japan-only trials, saving both time and cost in the long run.
• Trial data from Japan is seen as more credible and locally applicable, especially when reviewed by Japanese regulators, clinicians, and payers.
• Local site participation brings valuable real-world insights, reflecting Japanese clinical practices, patient behaviors, and standard-of-care differences that can influence treatment outcomes.

Ultimately, adding Japan to your global trial footprint helps ensure your data is both globally relevant and locally actionable, strengthening your position for regulatory success and market access in Japan.

Clinical Trial Sites in Japan – Approximate Numbers

• Thousands of potential trial sites: Japan has nearly eight times more hospitals than the UK, indicating a large pool of facilities suitable for clinical trials.
• 500–700 PMDA-registered, GCP-compliant sites: The Pharmaceuticals and Medical Devices Agency (PMDA) supports hundreds of active trial sites through regulatory oversight and clinical consultations.
• ~101 institutions with Certified Review Boards (CRBs): These institutions are authorized to oversee interventional clinical trials under Japan’s clinical research laws.

Investigators & Sites in Japan

Impact of Site and Investigator Selection

Choosing the right sites and investigators in Japan can significantly influence trial timelines, data quality, and regulatory outcomes. Investigators with relevant therapeutic expertise and prior trial experience are key to ensuring smooth execution, especially in complex studies.

Effective site selection supports better patient recruitment and retention, which is critical in Japan’s structured healthcare system. Sponsors should rely on feasibility studies, historical performance data, and alignment with the study’s therapeutic focus.

Important criteria include:

• Access to the right patient population
• Site capacity and infrastructure
• GCP compliance
• Investigators’ ability to communicate in English

Making informed site selections early helps minimize delays and enhances the overall success of the trial.

Key Challenges When Working with Japanese Sites

While Japan offers a highly capable clinical trial environment, sponsors may face several operational and cultural challenges when engaging with local sites.

• Language remains a key barrier. Most investigators prefer Japanese for communication, and many trial documents—including protocols, consent forms, and CRFs—need to be translated and localized to meet both regulatory and cultural expectations.
• Initial site engagement can be formal. Japanese institutions often value introductions through trusted local partners, and sites may conduct their own credibility checks before agreeing to participate in a trial.
• Cultural nuances matter. Building trust takes time, and maintaining respectful, consistent communication is critical. Understanding Japan’s professional culture can go a long way in strengthening collaboration and ensuring trial success.

How to Connect with Japanese Sites and Investigators

Finding the right sites and investigators in Japan can be challenging without local insight. That’s where Credevo comes in.

•  Collaborate with local CROs or SMOs
  Work with experienced local partners who have established relationships with clinical trial sites across Japan.  With Credevo, you can simplify this process by accessing trusted local networks
•  Partner with Japanese trial consultants or attend local conferences
  Engage consultants who understand the regulatory landscape, or attend regional conferences to connect with investigators and site networks directly.
•  Use clinical trial databases and regulatory resources (e.g., PMDA)
  Search official trial registries and consult regulatory bodies to find accredited and capable sites that meet your study needs.

 With Credevo, you can simplify this process by accessing trusted local networks, verified sites, and expert guidance for site selection in Japan.

We at Credevo help sponsors connect directly with qualified, experienced sites and investigators in Japan—whether you’re planning a Japan-specific trial or integrating Japanese sites into a global study. With our deep local network and regulatory expertise, we simplify the process from first contact to site initiation

Talk to Credevo — share your trial requirements, and we’ll match you with the most suitable sites, guide regulatory planning, and support local engagement every step of the way. Contact us

Conclusion

Japan continues to be a high-potential destination for clinical trials, offering strong infrastructure, regulatory alignment, and access to an important patient population. But success here depends on more than protocol design—it requires careful site and investigator selection, along with a solid understanding of local expectations.

To navigate Japan’s unique cultural and operational landscape, it’s essential to partner with experienced local experts who can guide engagement, streamline approvals, and ensure your trial runs smoothly from start to finish.

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Do you have questions about selecting clinical trial sites in Japan?

Whether you’re exploring Japan as a new region for your trials or fine-tuning your local strategy, our team can guide you through every step. Share your requirements using the form below, and we’ll help you navigate site selection, regulatory needs, and operational planning with confidence.

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