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Before a clinical trial of a new drug can be performed
to test a drug on human subjects, the sponsor must submit an Investigational
New Drug (IND) application to the US Food and Drug Administration
(FDA). The IND application has to be reviewed by the FDA within
30 days of submission. FDA approval is granted if the FDA does not
respond negatively, i.e. if a favourable response is received or
if the FDA fails to respond.
All clinical trials must furthermore be reviewed and approved by
an Institutional Review Board (IRB) before they can be initiated.
 Health
Care System
The USA does not have a national health care system covering all
citizens. The elderly, the poor and the disabled are assisted by
the government programmes Medicare and Medicaid. The majority of
Americans, however, have private insurance to help cover health
care costs; the medical insurance premiums may be subsidised by
employers.
ECRON/ABR
ECRON built a strategic alliance with ABR, Advanced Biomedical Research
Inc., Princeton, US, to open the countries of the European Community
as well as Central & Eastern Europe for research projects planned
in the US. Vice versa, European companies may contact us to get
in contact with US investigators, trial sites and CRO facilities.
ABR itself offers full service for clinical trials as well as own
phase-I facilities.
Offices/staff
in Europe
ECRON Headquarters, Hahnstr. 70, 60528 Frankfurt/Main, Germany
Phone: +49 (69) 66 80 30-0 Fax: +49 (69) 66 80 30-29
in US
ECRON/ABR, Princeton corporate office
117 Campus Drive, University Square, Princeton, New Jersey 08540,
USA
Phone: +1 (609) 818 1800 Fax: +1 (609) 818 0026
Clinical Research Center
241 Main Street, Hackensack, New Jersey 07601, USA
Phone: +1 (201) 678 0288 Fax: +1 (201) 678 0349
Email: us@ecron.com
Global
Megatrials 
Furthermore ECRON Headquarters
can deliver global megatrials with
Global CINRG, Inc. 5440 Laurel
Hills Drive, Sacramento, CA 95841-3106, USA Tel: (916)-338-6855, Fax:
(916)-338-4005
Links
US Food and Drug Administration
(FDA)
Center for Drug
Evaluation and Research (CDER)
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Michael S. Willett,
PharmD
President ECRON/ABR
North America |
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UNITED
STATES 
