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Early Development Services
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Clinical Services
With facilities in the US, The Netherlands and Central Europe PRA is able to offer over 220 beds worldwide and is equipped with the technologies and infrastructure for high quality, efficient
studies on a wide range of drugs and indications.
North America - United States
Our state-of –the-art, modern 80-beds Clinical Pharmacology Center in Lenexa, KS (US) offers an ultimate environment for conducting short and long term clinical pharmacology trials of all types.
With its large, very experienced clinical staff the clinic attracts wide range of subjects and boast of an average 96% retention rate during the studies.
Europe - The Netherlands
In The Netherlands, our 70-bed Clinical Pharmacology Unit in Zuidlaren provides an excellent environment for conducting a variety of early development phase studies utilizing most up-to-date
European expertise of its dedicated medical staff. This CPU also operates a dedicated isotope unit certified for conducting mass-balance (ADME),and metabolite profiling studies.
The second Clinical Pharmacology Unit in The Netherlands is located in Groningen and is a part of the university hospital. This 70-bed Unit collaborates closely with the hospital having an
instant access to a variety of sophisticated medical equipment, and emergency facilities.
Europe – Central Europe
PRA has a compact 8-bed Central European operation in Prague (Czech Republic) specializing in sophisticated studies with renally impaired patients. In addition PRA’s Central European operation has
access to number of hospital beds in Warsaw, Bratislava and Budapest to conduct Phase I studies in patient populations.
Large pool of healthy volunteers
PRA has access to a large pool of over 22,000 active healthy volunteers from The Netherlands, Belgium and the US. Also special populations, such as elderly men and women, post menopausal females,
overweight and obese people, and several other patient groups are available. For our in-house Phase I studies, volunteers are accommodated at our state-of-the art Clinical Pharmacology Centers ,
where they are under constant medical supervision. We have a comprehensive subject database augmented by active Internet recruiting.
Well-defined patient populations for Phase IIa
In order to provide needed patient populations for Phase IIa studies, we collaborate closely with local medical communities and have access to well-defined patient populations from surrounding
hospitals. In particular our Central European operation has conducted over 160 Phase I trials within the last 10 years in specialist early phase patient trials involving multiple sclerosis,
Parkinson's disease, epilepsy, essential tremor, cancer, CV and endocrinological (diabetes, obesity, thyroid hormone replacement) patients.
Design flexibility
We have significant experience in conducting studies according to well-accepted study designs: single or multi-period; parallel, serial or crossover; open-label, single or double blinded;
ambulatory or inpatient; pilot studies, studies utilizing drug run-in phase; and more. In open discussions with our sponsors we try to optimize designs in terms of time, resources and data
requirements, and clinical environments unique to each of our clinics.
Special equipment
To monitor safety and pharmacodynamics, we have devices available for continuous cardiac monitoring, ECG, blood pressure and oxygen saturation measurements. In addition experience and equipment
are available to investigate several other pharmacodynamic parameters, for example pupillometry, ergonometry, lung functioning, gastric pH measurements, coagulation tests, urodynamic tests.
In-house GMP grade pharmacy
We have attained extensive know-how in handling all types of formulations such as IV, SC or IM infusions and injections, oral solutions, suspensions or emulsions, tablets and capsules, intra-nasal
or inhaler techniques, as well as ointments and patches for dermal delivery studies. These formulations can either be provided by a sponsor, or prepared in our own fully GMP compliant (the
Netherlands) or GCP practicing (US) and well-equipped pharmacies. Additionally, we provide our own facilities to handle and prepare radiolabeled formulations for pharmacokinetic studies using
radioisotopes.
Reducing timelines to a minimum
Complete integration of activities (clinical research, bioanalysis and statistics) and close collaboration with the sponsor enables efficient management of the total development process, reducing
the timelines to a minimum. In many instances the complete Phase I-IIa development program can be completed within six months. For example EDS operation in The Netherlands through collaboration
with a preclinical research organization, was are able to integrate preclinical and clinical studies, so the project was completed within half the usual time.
Page last updated:
06 August 2008
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