As one of the pioneers in the field of clinical trial/research in Japan, we have led the industry on the front lines for over the last 35 years. The following are the reasons why we have been chosen as our sponsors’ clinical trial sites in Japan.
Unrivaled Study Experience in Early Clinical Trials
- A total of over 5,700 protocols to date
- More than 1,700 phase 1 studies over the last 35 years
- Cold Pressor Pain Evaluation
- Dermatopharmacokinetics (DPK)
- Polysomnography (PSG)
- In-house Formulation
- pH Continuous Monitoring
- Magnetic Stimulations
- Vaginal Ultrasound Test
Compassionate Consultation and Support
- Investigation of potential project viability, and review of go-ahead project documentation for clinical trial submission in Japan.
- Consultation and advice for study protocol development based on our 35-year experience.
- Support for IRB 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. Details regarding our GCP inspection experience can be found here.
- Culture and language liaison support via our native English, Korean, and Chinese speaking staff, facilitating a smooth clinical trial process.
Robust Support from Our Medical Group’s Hospitals
- 220+ physicians’ expertise in over 27 therapeutic areas
- Emergency treatments in the case of SAEs
- Ongoing efforts to expand our patient study capabilities
Extensive Industry Network
- In addition to our in-house subject recruitment team, we have been working with a study participant recruitment company, achieving a 100% subject enrollment fulfillment rate for our healthy volunteer studies over the last 35 years.
- We have collaborated with most Japanese CROs as well as global CROs. Together with these CROs, we can provide full clinical development services for our sponsors’ success in Japan and around the world.
- We have established strong relationships with many Japanese pharmaceutical companies and key industry personnel through our clinical studies. Using these networks built on trusts and past successes as well as our cultural and multi-language know-how, SOUSEIKAI has helped foreign companies successfully connect with potential business partners in Japan.
- Many investors/VCs are now looking for innovative biotech companies around the globe that are developing promising drugs for global pharmaceutical markets, including Japan. SOUSEIKAI has been actively helping with this process, as well as supporting the smooth and quick transition from their discovery to the subsequent related clinical development in Japan.
Commitment to Highest Quality Standards
- When the ICH-E6 (R2) regarding Quality Management System (QMS) and Risk-based Approach (RBA) in clinical trials were implemented in 2016, SOUSEIKAI was a trusted site chosen where both Japanese and overseas sponsors tried out their studies with this new risk-based monitoring approach.
Since our foundation in 1986, in a tireless effort to maintain and improve on status quo as the highest quality sites in the industry, we adhere to a strict regimen of constant staff training and education, self-motivated learning, proactive ingenuities, and actively incorporate successful cases found in other countries. Adapting to the constant changing needs of the industry, SOUSEIKAI continues to evolve.
- We're proud to announce that we have been awarded the Clinical Research Site Award 2016 for Quality work by INC Research (Currently, Syneos Health).