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GLOBAL REACH

Japan

Linical is a leading CRO in Japan, with the clinical and regulatory expertise to help clients successfully navigate the nuances of clinical trials in Japan.

CRO Services in Japan

While Linical has grown across the globe to cover the world’s top clinical development regions (North America, Europe, and Asia-Pacific), our company originated in Japan nearly two decades ago. Founded by leaders in drug development from a Japanese pharmaceutical company, Linical was created with a vision of advancing clinical research for new and unmet medical needs. Linical is publicly traded on the Tokyo Stock Exchange, providing financial stability with a focus on quality delivery for our clients and the patients we help improve therapies for.

There are many benefits to conducting clinical trials in Japan, and Japan continues be the third largest pharmaceutical market in the world. Japan remains one of the most important regions for both local and global biopharmaceutical companies, with continued demands for innovative therapies. Through partnering with a contract research organization (CRO) in Japan, pharmaceutical and biotechnology companies can achieve more successful outcomes.

Experience

Choosing an Experienced Japanese CRO

When designing and executing clinical trials in Japan, it is vital to work with an experienced Japanese CRO. The right Japanese CRO partner will have actual staff located in Japan, providing the necessary guidance and network to optimize timing and costs of Japanese clinical trials. Clients should look for a CRO with a proven track record of conducting clinical trials in Japan, providing the experience, resources, and know-how every step of the way. They will be knowledgeable about the nuances of the clinical development landscape in Japan, adding value in a multitude of areas such as:

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Protocol development and study design considerations
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Patient population dynamics and a robust recruitment strategy for Japanese patients
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Deep knowledge of local regulations and PMDA requirements
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Relationships with medical centers and physicians in Japan
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Effective timeline and cost management strategies
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Focus on quality through the project
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Smooth communication and navigation of cultural considerations

Navigating Clinical Trials in Japan

Linical’s team of local experts possess deep, local regulatory knowledge and excellent relationship with sites, KOLs, and PIs, providing guidance and the best solutions to avoid obstacles and ensure the success of your clinical studies in Japan.

Comprehensive Japan CRO Services

Linical is a full-service clinical development partner, with capabilities spanning all key areas of clinical development, from planning and protocol development, to regulatory and compliance, to medical and clinical operations. We provide comprehensive, integrated CRO services in Japan from early phase through late phase development, including drug development strategy and clinical trial management services. Our CRO services in Japan include:

Feasibility and study start up
Project management
Medical affairs and pharmacovigilance
Clinical monitoring
Patient recruitment
Biometrics
Protocol development and study design
Regulatory consulting
Regulatory affairs
Quality assurance
Medical writing

End-to-end Support for Clinical Development in Japan

Linical offers support to biotech and pharma companies from the earliest phase of development, not only proving full-service drug development services but also helping companies interested in entering the Japanese market that may be unfamiliar with its regulations. We help organizations with market access, development & regulatory strategy, PMDA consultation, and can aid companies in the process of looking for partners or licensing. Linical is your gateway to the Japanese clinical development market.

Right Size.
Right Reach.
Right Team.

The Right-Choice CRO

At Linical, we believe in supporting our clients throughout their unique clinical development journey, with a shared goal of bringing promising new therapies to patients all over the world. We have the right size, the right reach, and the right team. Let us support your journey, the right way.

Successful clinical trials start with Linical.

Don’t let the complex clinical development journey hold you back. With Linical, you can overcome obstacles, save valuable time and money, and reach your goals. 

01 Request a proposal

We start by listening to your needs and understanding your goals to ensure we’re the right CRO for you.

02 Get a plan for success

We propose solutions that proactively tackle obstacles, optimize your trial design, and position you for success every step of the way.

03 Execute with confidence

We’ll guide you through each phase of the process, offering personalized support and a full range of services to help you achieve a successful trial. We are not a “one size fits all” CRO.

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Request a proposal from Linical, today