For Biotech Firms & Startups

 

Your Partner in Bringing the Cutting Edge to the Japanese Market 

Our doctor-owned independent CRU is excited about biotech medical innovation. P-One Clinic Executive Director and principal investigator, Dr. Kenichi Furihata often says how eager he would be to work with more biotech startups and other mid-sized movers and shakers in the pharmaceutical industry.

Much of the cutting edge in medical research is thanks to smaller firms with new ideas and daring approaches. We want to be a part of that dynamism and to help you get a foothold in the Japanese market.

A common misconception is that CRUs in Japan are owned by CROs. In fact, we recommend that you start the conversation with us directly, without hiring a middleman. Over the 15 years since P-One Clinic was founded, we have developed networks of distinctive CROs, and can introduce you to all the consulting and industry partners you will need to succeed in Japan.

From your first foray into the regulatory environment to approval and marketing of your product, let us be your guide. 

Although P-One Clinic is by no means the largest or oldest clinical research group in Japan,  you will find that we are more flexible and understanding of forward-looking companies with a 21st century, global outlook. With 46 beds spread across independent wards for concurrent panels or multiple simultaneous protocols, we have all the on site staff, facilities, and equipment for a safe, efficient, and accurate outcome. 

We can help you obtain early phase data to expedite the approval process and tap the Japanese pharmaceutical market, still the third largest in the world and a stepping stone to the burgeoning markets of Asia. Our experienced team of doctors can handle numerous treatment areas. For unique IPs, treatment domains, technologies, and tests,  we can enlist specialized doctors from partnered medical institutions as subinvestigators. 

One of our ethnobridging studies may be the key to carry your data across borders, and our recruiters can always help with Asian targets populations, often at a lower price than many countries in the West. Or if you are considering licensing your innovative research further down the road, we can put you in touch with the major domestic pharmaceutical companies once you are ready.

 

P-One Clinic is fully compliant with ICH-GCP. No action was required after our six site inspections from PMDA domestic regulators. Our quality assurance systems are in harmony with ISO 9001: 2008 (UKAS), and we are happy to offer our system of in-house SOPs as a model to brainstorm and develop your protocol and procedures.

 Native speakers of English, Chinese, Korean, and Japanese are here to ensure smooth communications.

 

WE ARE YOUR INNOVATION GATEWAY TO JAPAN AND ASIA .

Contact us today to start the conversation.