 Save Cost and Development Time
Our Offer
Our experience shows that Phase I bridging studies can be conducted outside Japan and based on our expertise are acceptable to the Japanese authorities.
Why choose FOCUS?
- Bridging Japanese and White volunteers at one site under one protocol in compliance with ICH-E5.
- Extensive experience with bridging studies (30 studies to date!).
- Bridging data accepted by the Japanese authorities (MHLW).
- 650 high quality and active healthy Japanese volunteers (male and female) in panel as guarantee for fast recruitment rates.
- Fulltime Japanese staff to recruit and manage subjects participation in the studies.
- State-of-the-art Phase I Clinical Pharmacology Units in Neuss (130 beds) and Düsseldorf (hospital based, 8 beds).
- Inspected four times by the US-FDA with a successful outcome on each occasion.
- Additional in-house services such as Immunology Lab, Clinical Lab, Bioanalysis, Data Management, Biostatistics, Medical Writing, Regulatory Affairs, Drug Formulation, Clinical
Trials Supplies and Drug Import are available - all under one roof and working the highest quality standards.
- Extensive expertise in Clinical Pharmacolgy, proven by 75 first-into-man studies and
more than 600 Phase I/II studies in nearly all therapeutic areas within the last 15 years.
- Low study costs compared with development in Japan.
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