HOW we can help
CLINIC RESOURCES: The Numbers
- A 400 bed, 5 clinical research unit Global Clinical Research Center
- A 375 staff workforce, including 56 physicians exclusively dedicated to clinical trial research
- 1,600 studies. 4,000 protocols. An exhaustive list of therapeutic areas
CONSULTATION: Support , Access , Fluency
- Investigation of potential project viability, and review of go-ahead project documentation for clinical trial submission in Japan.
- Consultation and support for project related documentation to the PMDA, such as CTN submission, including review of and help developing protocol (and writing) for both informed consent (IC) and investigator’s brochures (IB).
- Access to our own bi-monthly Central IRB with document preparations in Japanese as well as in English, upon request. Extensive experience with foreign clients. Well versed in various GCP governances and adaptation of j-GCP/ICH-GCP compliancy.
- Culture and language liaison via our foreign relations department of native English, Korean, and Chinese speaking staff, facilitating a smooth clinical trial process.
RECRUITMENT: Many Helping Hands
Combination in-house recruitment division and UNICS recruitment company make for a high caliber and efficient participant recruitment team. Our participant entering period boasts a 100% enrollment fulfillment rate.
SPECIALIZATIONS: Depth and Diversity
A diverse, broad range of specialties and procedures allows us the flexibility to access a cross-over knowledgebase of information and resources, aiding in the thoroughness and quality of our studies.
INVESTMENT , QUALITY , CARE
Cutting costs by efficiency. Raising the bar by ambition.
It was thought the Japanese regulatory process was conservative, expensive, and slow. The reality is that through substantial investment by Japan’s PMDA, it has overcome these past negative biases. The approval procedures have become both interactive and interchangeable with the current global standards of the pharmaceutical industry. This, coupled with our experience in the field of clinical research lends to both quality and efficiency of our trials, of which the byproduct is cost effectiveness.
For estimate inquiries regarding specific protocols, please contact us here.
We're proud to announce that we have been awarded the Clinical Research Site Award 2016 for Quality work by INC Research.