Focus Clinical Drug Development GmbH FOCUS Clinical Drug Development GmbH, based in Neuss/Dusseldorf, Germany, offers early drug development services to support pharmaceutical clients in their effort to generate and register new pharmaceutical products. FOCUS currently services many international blue chip companies and the biotech industry with high quality clinical studies. The FOCUS state-of-the-art facilities in Neuss comprise a 68-bed clinical pharmacology unit (with 26 intensive care beds), clinical trials supplies unit (including formulation and small-scale GMP production), clinical and bioanalytical labs, data management, PK and biostatistics groups, a QA department and on-site archive - all under one roof! In addition, FOCUS has two subsidiaries: one in Prague, the Czech Republic and one in Moscow, Russia for controlled patient studies with offices supporting medical and regulatory affairs and clinical monitoring covering Central and Eastern Europe. The FOCUS Clinical Research Unit in Moscow, located within a university hospital performs Phase I and II studies in rare patient populations. The FOCUS core business includes first-into-man studies and in-house early patient studies as well as bridging studies involving Japanese volunteers. The FOCUS expertise: 65 NCEs first-into-man in the last 11 years and more than 400 Phase I/II studies in nearly all therapeutic areas. FOCUS works according to ICH-GCP guidelines and to international standards of GLP and has been inspected several times by the FDA for pivotal NDA-studies. On each occasion the outcome of the inspection was highly satisfactory for both FOCUS and the sponsor. In order to better serve the needs of our clients, and based on our extensive experiences with many biotechnology companies, we have implemented a new comprehensive service called: Strategic & Operative Product Development Management (PDM). Through our team of experienced, market-focused product developers we offer a full-service package or alternatively certain modules such as strategic marketing assessment and product definition, development plan, project management and conduct of all preclinical and clinical needs up to Proof of Concept. Thus, we support the Biotech companies both to define
the lead direction of a development programme and to implement the
practical aspects of such a product development task. Why are we different? Because we do not only provide strategical advice but we also put our suggestions into practice! In this context, we usually surprise our clients how easily, quickly and at relatively low costs this can be achieved. We have currently several projects running succesfuly under the PDM Concept.
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