We would like to inform our sponsors about our new capabilities and latest accomplishments:
- The recent FDA pre-approval inspection audit of our Phase II clinical study site and office facilities in Moscow, Russia, was flawless and resulted in no FDA 483 remarks for the sponsor
- Our biomarker facility in Heidelberg, Germany, was GLP qualified in February 2009
- Several first-in-human studies with biologicals have been performed in our hospital-based ward in Düsseldorf, Germany, which has just been upgraded from six to 12 beds
- Our expertise in the conduct of ethnic bridging studies has been expanded by the
addition of more Asian and African ethnicities, and a broader range of study objectives - We recently created a pharmaco-imaging centre with three university experts in the region of Neuss, Germany. By adding these high-tech imaging technologies to the FOCUS exploratory clinical expertise, we hope to offer our sponsors more
opportunities to perform state-of-the-art studies
Contact FOCUS Clinical Drug Development for more information about any of these news items.