For information, contact Mary Briggs SCIREX Corporation 1.800.646.4117
SCIREX A “Notable” Integrated Service Provider Says CenterWatch Europe Newsletter SCIREX was one of four companies featured in the summer, 2001 edition of CenterWatch Europe, an electronic newsletter providing information on the clinical trials industry in the European Union. The article (attached), titled “European CROs Muscle into the Study Conduct Services Market,” focuses on the emergence of integrated service providers—contract research organizations (CROs) that also provide site management services—and their proliferation in the site management market. According to the article, integrated service providers, also known as hybrid site management organizations (SMOs) in the U.S., are highly desirable because of their ability to offer project management and study contract services. With their ability to provide this all-in-one package, and their access to global markets, hybrid service providers are gaining a healthy share of SMO capital; last year, integrated service providers enjoyed one third of the $33 million in total revenue generated by SMOs in Europe. Variations in study conduct within the European marketplace pose challenging obstacles when it comes to implementing clinical trials. With their standardized research guidelines and protocols, and also staffs of trained personnel in multiple countries, integrated service providers offer continuity in a culturally diverse marketplace. SCIREX, founded in Austin, Texas, in 1996, was one of the first companies in the U.S. to offer both CRO and SMO services. The company developed a model for acute pain that is now “the gold standard for the FDA for acute pain models,” Dr. Ingrid Klingmann, SCIREX’s European general manager, told CenterWatch Europe. She explained that this model was implemented at the company’s first European site, the Eastman Dental Institute in London. At Eastman, SCIREX employees provide clinical trial services in tandem with a principal investigator from the Institute. With trained personnel and investigators on-site, SCIREX “has been able to distinguish reliably in all its U.S. and European studies…between the placebo, the comparator drug and the test drug…This is only possible if you do those studies with very high precision and standardization,” Dr. Klingmann said. Transatlantic portability would be a crowning achievement for any international hybrid organization. According to CenterWatch Europe, SCIREX is working towards that goal by (continued)
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“building multinational investigator networks to which we can bring our personnel to coordinate study sites,� Dr. Klingmann said. SCIREX has CRO personnel in Belgium, the U.K., Germany, Poland, Hungary, France, the Netherlands and Spain, with negotiations in the works for Sweden, Bulgaria, Russia and Italy. The article also featured Kendle, Quintiles, and Clinville/CRDP as leading integrated service providers. Like SCIREX, these companies profit from their ability to offer standardized CRO/SMO services throughout multiple sites in Europe, and along with SCIREX, are formidable challengers to the top five traditional SMOs: GCP, Synexus, Profiad, Center for Clinical Trials and Intercern. In response, many traditional SMOs are expanding their scope of services. CenterWatch is a Boston-based publishing and information services company reaching patients, pharmaceutical, biotechnology and medical device companies, CROs and clinical research centers around the world. CenterWatch Europe is a quarterly electronic newsletter dedicated to providing news and information on the clinical trials industry in the European Union. CenterWatch Europe reports on emerging trends in clinical research, new outstanding practices, investigative site initiatives and more. SCIREX is a leading pharmaceutical development company with offices in the U.S. and Europe. Its services include clinical trials planning and management (Phases II-IV), data management and statistics services, site management, regulatory affairs, e-research and commercialization services. ###