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A Leading Global Clinical Research Organization (CRO) Providing Services in All Phases of Clinical Trials
PRA International is one of the world's leading global clinical research organizations, conducting clinical trials in more than 75 countries across six continents. PRA provides outsourced clinical services across all phases of pharmaceutical and biotech drug development. Through its 30+ years of experience, PRA has developed the operational and therapeutic expertise to provide high quality, global service while maintaining our differentiating PERSONAL ELEMENT of commitment to excellence.
Early Development Services (Phase I-IIa)
PRA's Early Development Services (EDS) group provides comprehensive services for Phase I and Phase IIa studies, including: • Phase I and IIa clinical research • Bioanalytical research • Data support
Our client base spans a wide array of pharmaceutical and biotech companies in the United States, Europe, and Japan. EDS conducts more than 100 complex studies and over 200 bioanalytical studies yearly for studies recruiting healthy volunteers or special patient populations.
Bioanalytical Laboratory
PRA's Bioanalytical Laboratory facility in Assen, The Netherlands has more than 100 highly educated and experienced employees. This is a GLP-compliant laboratory that began operating in the mid 1980's. Located in close proximity to PRA's Phase I clinics in Zuidlaren and Groningen, the facility's analytical capabilities include: • Equipment for mass spectrometry • Ultra performance liquid chromatography • Biomarkers • Biochemistry & immunochemistry • Radioisotope analysis • Handling of biohazard samples
PRA's laboratory specializes in: • Development, implementation and validation of assay methods • Bioanalysis of samples from clinical and preclinical studies, conducted either in our own clinical research center or client study centers • Bioanalytical protocol design and writing • Preparation of bioanalytical reports to standard templates or as specified by the client Over 25 successful sponsor audits and visits each year yield results that demonstrate our high standards of excellency. Regulatory audits confirm our compliance with all standards of GLP.
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