Corporate overview of PRA International

PRA, a leading global clinical research organization (CRO), conducts clinical trials in more than 80 countries across six continents through our 38 global offices. PRA provides outsourced clinical services for all therapeutic areas across all phases of pharmaceutical and biotech drug development. As a full-service CRO, PRA offers a broad array of services encompassing the entire spectrum of clinical development programs, from filing of Investigational New Drug and similar applications to product registration and post-marketing surveillance.

PRA's therapeutic expertise, global reach, technology suite, and project experience, combined with extensive local knowledge, enable our project teams to deliver consistent and on-time performance for our clients. Bolstering these abilities is PRA's unique philosophy, THE PERSONAL ELEMENT, which recognizes that true client service comes only from trained, empowered, and dedicated employees. Our staff is encouraged to use innovation and personal commitment to accelerate the development lifecycle.  

PRA stands out among CROs based on our therapeutic expertise, ability to successfully lead studies with this knowledge, and proven track record of successful conduct of studies leading to regulatory approval. Across all therapeutic areas, PRA has a repeat business rate of over 80%. This metric clearly demonstrates our ability to deliver projects successfully and highlights our long-standing relationships with many biotechnology and pharmaceutical companies. Our relationships include everything from supporting entire therapeutic pipeline development to providing specialized services (e.g., drug safety and data management) through our dedicated operations centers and teams.

PRA's Early Development Services group provides comprehensive services for Phase I and IIa studies starting with feasibility assessments, study design, and protocol and CRF development. As experts in recruitment, we have built relationships with a large base of ready and loyal subjects, healthy volunteers, and special patient populations. We also provide supporting services from data management to pharmacy services, including manufacturing. We round out our services with clinical study reports, medical writing and regulatory support. Our primary expertise is with complex types of studies in which safety, intelligent design, and a wide range of pharmacodynamic assessments are critical factors.

PRA's Bioanalytical Laboratories are strategically located in Europe and North America. Our laboratories offer a full range of services across all phases and are GLP-compliant. PRA's laboratories specialize in the development, implementation and validation of assay methods; bioanalysis of samples from preclinical and clinical studies; bioanalytical protocol design and writing; and the preparation of bioanalytical reports to standard templates or specified by our clients.

PRA's Product Registration group has been instrumental in helping our clients conduct complex, global, multi-center trials and has achieved more than 35 drug approvals across a range of therapeutic areas. PRA has been successful in helping our clients achieve their goals because of our therapeutic expertise, commitment to quality and the close involvement of our entire project team.

PRA's Late Phase Services group provides comprehensive planning and services for all varieties of interventional and non-interventional post-marketing studies on a global scale. Industry-leading strategic, scientific, medical and epidemiological experts support PRA's Late Phase operational team. Late Phase Service offerings include safety surveillance/post-authorization safety studies, large simple trials, registries, restricted/expanded/limited access programs, retrospective studies, RiskMaps, risk evaluation and mitigation strategy (REMS/EU-RMP), and diagnostic and biomarker research.