PAREXEL International Corporation, a biopharmaceutical services company, provides clinical research, clinical logistics, medical communications, consulting, commercialization, and advanced technology products and services to the worldwide pharmaceutical, biotechnology, and medical device industries. The company’s product and service offerings include clinical trials management, observational studies and patient/disease registries, data management, biostatistical analysis, epidemiology, health economics/outcomes research, pharmacovigilance, medical communications, clinical pharmacology, patient recruitment, clinical supply and drug logistics, post-marketing surveillance, regulatory and product development and commercialization consulting, health policy and reimbursement and market access consulting, medical imaging services, regulatory information management (RIM) solutions, ClinPhone randomization and trial supply management services (ClinPhone RTSM), electronic data capture systems (EDC), clinical trial management systems (CTMS), Web-based portals, systems integration, patient diary applications, and other product development tools and services. The company’s services complement the research and development and marketing functions of pharmaceutical, biotechnology, diagnostics, and medical device companies. The company conducts business in healthcare markets around the world, including the United States (U.S.), Argentina, Australia, Austria, Belarus, Belgium, Bosnia, Brazil, Canada, Chile, China, Colombia, Croatia, the Czech Republic, Denmark, Estonia, Finland, France, Georgia, Germany, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Korea, Latvia, Lithuania, Malaysia, Mexico, the Netherlands, Norway, Peru, the Philippines, Poland, Romania, Russia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey, Ukraine, the United Kingdom (U.K.), and Vietnam. Segments The company has three segments: Clinical Research Services (CRS), PAREXEL Consulting Services (PC), and PAREXEL Informatics (PI). CRS CRS constitutes the company’s core business and includes all phases of clinical research from first-in-man trials, where a medicinal entity is tested on human subjects for the first time, through post-marketing studies, following approval by the presiding regulatory body. CRS service offerings include clinical trials management, observational studies, patient/disease registries and post-marketing surveillance, data management and biostatistics, epidemiology and health economics/outcomes research, clinical logistics, pharmacovigilance, and clinical pharmacology, as well as related medical affairs, patient recruitment, and investigator site services. CRS offers services for the design, initiation and management of clinical trial programs, a critical element in obtaining regulatory approval for biopharmaceutical products. The company has performed services in connection with clinical trials in most therapeutic areas, including oncology, cardiology, infectious diseases, neurology, allergy/immunology, endocrinology/metabolism, gastroenterology, obstetrics/gynecology, orthopedics, pediatrics, psychiatry, pulmonology, rheumatology, dermatology, genitourinary, ophthalmology, and transplantation. The company’s multi-disciplinary clinical trials group examines a product’s existing preclinical and clinical data to design clinical trials to provide evidence of the product’s safety and efficacy. CRS can manage many aspects of clinical trials, including: study protocol design; Case Report Form (CRF) design; site and investigator recruitment; patient enrollment; study monitoring and data collection; data management; biostatistics and programming; report writing; medical services; project management; and clinical logistics. Clinical trials and observational studies are monitored and conducted by CRS in adherence with Good Clinical Practice (GCP) and Good Pharmacoepidemiological Practice (GPP), respectively. Early Phase The Early Phase business unit of CRS encompasses the early stages of clinical testing, when a product is first evaluated in humans to assess the potential safety an
parexel international corp
195 West Street
Waltham, MA 02451
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