251 286 - Biotech Bayern
251 286 - Biotech Bayern
251 286 - Biotech Bayern
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FGK Clinical Research GmbH<br />
CRO<br />
Keywords: Clinical Research, Drug Development<br />
As contract research organization FGK Clinical Research GmbH in connection<br />
with a network of partners provides a wide range of services in drug and<br />
medical device development, from early conception until final report (statistical<br />
consulting, project management, monitoring, data management, statistical<br />
analysis, medical writing). FGK has a focus on biotech and medical device<br />
companies which need more support and consulting in the clinical drug<br />
development process than pharmaceutical companies. In detail, services<br />
offered include: Phase I trials in cooperation with university-based pharmacological<br />
institutions, Phase II-IV trials, Post marketing surveillance, and<br />
special services such as Pharmacoeconomics, Quality of life reviews, Expert<br />
reports, and Organization of Opinion-Leader Meetings.<br />
FGK Representative Service GmbH<br />
CRO<br />
Keywords: Drug Development, Clinical Research<br />
FGK Representative Service GmbH was founded as a subsidiary of FGK Clinical<br />
Research GmbH and Dr. Anthony W. Fox, Carlsbad, CA, to offer the service of<br />
legal representation for sponsors outside the European Community. According<br />
to European legislation (2001/20/EC), an EU based legal representative is a<br />
prerequisite for trials initiated by sponsors that are not established inside the<br />
European Community. As a legal representative, FGK Representative Service<br />
GmbH may act on behalf of a sponsor concerning interaction with local ethics<br />
committees and local authorities as well as liability and indemnity. This service<br />
is not limited to studies overseen by the parent company FGK Clinical Research<br />
GmbH, but it is open for studies performed by other CROs, pharmaceutical,<br />
biotech or virtual companies.<br />
Fresenius <strong>Biotech</strong> GmbH<br />
PHARMA & CHEMICAL INDUSTRY<br />
Keywords: Drug Development, Hematology, Immune Therapy, Antibody, Cell<br />
Therapy, Gene Therapy, Oncology<br />
Fresenius <strong>Biotech</strong> GmbH, a company of the Fresenius Health Care Group, focuses<br />
on the clinical development and marketing of biopharmaceuticals in the fields<br />
organ transplantation, oncology, viral infection and organ regeneration.<br />
Fresenius <strong>Biotech</strong>'s Antibody Division includes the production and marketing<br />
of the immunosuppressive agent ATG Fresenius S and, together with TRION<br />
Pharma GmbH, the clinical development of the trifunctional antibodies<br />
catumaxomab and ertumaxomab for cancer therapy. The Cell Therapy Division<br />
concentrates on the development of innovative strategies for treatment of AIDS,<br />
tolerance induction and organ regeneration.<br />
Contact:<br />
Martin Krauss<br />
Heimeranstr. 35<br />
D-80339 München<br />
Phone: +49 (0) 89 893119-0<br />
Fax: +49 (0) 89 893119-20<br />
E-Mail: martin.krauss@fgk-cro.de<br />
Internet: www.fgk-cro.de<br />
Contact:<br />
Dr. Edgar J. Fenzl<br />
Heimeranstr. 35<br />
D-80339 München<br />
Phone: +49 (0) 89 893119 22<br />
Fax: +49 (0) 89 893119 20<br />
E-Mail: edgar.fenzl@fgk-rs.com<br />
Internet: www.fgk-rs.com<br />
Contact:<br />
Dr. Axel Wiest<br />
Am Haag 6-7<br />
D-82166 Gräfelfing<br />
Phone: +49 (0) 89 30 65 93 39<br />
Fax: +49 (0) 89 30 65 93 67<br />
E-Mail: info@fresenius-biotech.com<br />
Internet: www.fresenius-biotech.com<br />
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