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Services

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Early Development Services

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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 such as renally and hepatically impaired, elderly, post-menopausal women, sterilized healthy females and overweight/obese subjects. In addition we offer studies involving populations of patients with specific medical conditions such as diabetes mellitus, asthma, COPD, allergic rhinitis, dislipidemia, Parkinson disease, rheumatoic arthritis, psoriasis, 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, the United States, and Central and Eastern Europe, PRA can perform all aspects of Phase I and IIa trials, including:

• First-in-human studies
• Single and multiple dose safety and tolerability studies
• Food effect
• Proof of concept studies
• Interaction studies with drugs and food
• Mass balance/ADME studies
• Microdosing studies
• Single and multiple dose bioavailability studies
• Bioequivalence studies
• QTc- prolongation and intensive ECG studies
• PK studies in renally impaired patients
• PK studies in hepatically impaired patients
• Special populations studies
• Special formulations
• Vaccine studies
• Studies with biotechnology-derived therapeutic products

As well as the more routine early phase studies PRA specializes in the more complex, first-in-human studies and studies with delicate pharmacokinetic or pharmacodynamic objectives, by using extensive methodologies PRA has developed.

Page last updated: 07 August 2008