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Services
[ Global Product Development Services ] [ Trials Management Services ] [ Dedicated Clinical Operations Centers ] [ Local Country Clinical Trial Environments ] [ Early Development Services ] [ Late Phase Services ] [ Drug Safety Management ] [ Electronic Regulatory Submissions ]
Early Development Services
[ Clinical Services ] [ Bioanalytical & Clinical Laboratory Services ] [ Regulatory Environment ] [ Central and Eastern Europe ]
Capabilities
Since 1984, PRA has conducted Phase I and IIa
studies for almost every major pharmaceutical
company in Europe, the United States and Japan,
as well as for many renowned biotech companies.
Our experience includes studies in healthy
volunteers as well as special populations or
those with specific medical conditions such as
diabetes mellitus, asthma, respiratory and
cardiovascular diseases, and HIV. Since 2000,
PRA has also conducted studies involving
vaccines for some of the world’s deadliest
viruses/bacteria, including yellow fever,
cholera, smallpox, influenza, West Nile virus
and Japanese encephalitis.
Through our
clinical and
laboratory facilities
in The Netherlands and the United States, PRA
can perform all aspects of Phase I and IIa
trials, including:
- First-in-human studies
- Single and multiple dose safety and
tolerability studies
- Proof of concept studies
- Interaction studies
- Mass balance/ADME studies
- Single and multiple dose bioavailability
studies
- Microdosing studies
- Vaccine studies
- Studies with biotechnology-derived
therapeutic products
We specialize in the more complex,
first-in-human studies and studies with delicate
pharmacokinetic or pharmacodynamic objectives,
using extensive methodologies that we have
developed. In addition, The Netherlands provides
an advantageous
regulatory environment.
Page last updated:
03 July 2008
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