ViroPharma Chooses Medidata Solutions as Its Standard for Global Clinical Trials Management.Medidata Rave Emerges as Solution of Choice for Leading Biopharmaceutical Company after a Rigorous 10-Vendor Evaluation NEW YORK New York, state, United States New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of -- Medidata Solutions, a global provider of electronic clinical data capture, management and reporting solutions, today announced that Medidata Rave[R] has been selected by ViroPharma Incorporated as its enterprise-wide e-clinical platform. After an extensive 10-vendor review process, ViroPharma chose Medidata Rave for the collection and management of clinical data for all global Phase I-III studies in the U.S., Sweden, Canada, Germany, Belgium and France. With a focus on the development and commercialization of products used by physician specialists in hospital settings to treat serious diseases, ViroPharma is recognized worldwide for the advancement of innovative products addressing unmet medical needs. Because ViroPharma conducts trials throughout North America and Europe, the company needed a clinical data management solution that could scale globally, while allowing investigators and monitors to manage and view data in real-time. ViroPharma also required a solution that would provide ease of study build and deployment with intuitive navigation for investigators worldwide. While ViroPharma had piloted electronic data capture (EDC EDC See: Export Development Corp. ) solutions for several years, in September 2005 the company began an evaluation of EDC vendors in order to standardize on one solution. After an initial review of proposals, six vendors underwent technical evaluations. From this group, ViroPharma selected four vendors to complete on-site evaluations. "In the end, we chose Medidata Rave as our standard because it best meets our needs through features such as a user-friendly interface and robust data management. We were also impressed with the clinical and technical expertise of Medidata's professional services personnel," said Patty Wolf, clinical data manager at ViroPharma. "Medidata Rave allows us to operate very efficiently with our clinical teams, and its ability to integrate with other applications should facilitate future improvements to our clinical trial processes." ViroPharma has implemented Medidata Rave for 15 trials to date and has forecasted its role in additional trials in 2007. Unlike other platforms, Rave allows users to work in different countries against a single, global, centrally-managed repository of clinical data - allowing for real-time electronic access of trial data. For investigators, this means reduced time entering in the case book per patient due to automatic query generation, and requires less storage space than paper case report forms. "ViroPharma's selection of Medidata Rave from a group of 10 vendors speaks to the industry-leading ease of use, flexibility and completeness of our solution for investigators, monitors and data managers within any phase of a clinical trial," said Tarek Sherif she·rif also sha·rif n. 1. A descendant of the prophet Muhammad through his daughter Fatima. 2. The chief magistrate of Mecca in Ottoman times. 3. A Moroccan prince or ruler. , CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Medidata Solutions. "The selection of Medidata Rave as ViroPharma's standard for clinical trials management demonstrates our ability to scale our product and services to meet the needs of a global client. We look forward to working with ViroPharma as they continue to increase the value of their clinical research investments." About ViroPharma Incorporated ViroPharma Incorporated is a biopharmaceutical company dedicated to the development and commercialization of products that address serious diseases treated by physician specialists and in hospital settings. ViroPharma commercializes Vancocin(R), approved for oral administration for treatment of antibiotic-associated pseudomembranous colitis pseudomembranous colitis Antibiotic-associated colitis, necrotizing colitis GI disease An acute illness, with often severe diarrhea that follows antibiotic therapy with ampicillin, clindamycin, metronidazole, etc, which eliminate the Pt's native bacterial flora, caused by Clostridium difficile Clostridium difficile A common cause of bacterial colitis; it is the causative agent in 99% of pseudomembranous colitis, and 20-30% of antibiotic-associated diarrhea and enterocolitis enterocolitis /en·tero·co·li·tis/ (-ko-li´tis) inflammation of the small intestine and colon. antibiotic-associated enterocolitis caused by Staphylococcus aureus Staphylococcus au·re·us n. A bacterium that causes furunculosis, pyemia, osteomyelitis, suppuration of wounds, and food poisoning. Staphylococcus aureus Staphylococcus pyogenes , including methicillin- resistant strains (for prescribing information, please download the package insert package insert Pharmacology A synopsis of key physicochemical, pharmacologic, clinical efficacy, and clinical safety properties of a prescription drug, bundled therewith, intended to be highly readable and helpful to clinicians looking for specific at http://www.viropharma.com/docs/pulvules_pi.pdf). ViroPharma currently focuses its drug development activities in viral diseases including cytomegalovirus cytomegalovirus (sī'təmĕg'əlōvī`rəs), member of the herpesvirus family that can cause serious complications in persons with weakened immune systems. (CMV CMV cytomegalovirus. CMV abbr. 1. controlled mechanical ventilation 2. cytomegalovirus Cytomegalovirus (CMV) ) and hepatitis C Hepatitis C Definition Hepatitis C is a form of liver inflammation that causes primarily a long-lasting (chronic) disease. Acute (newly developed) hepatitis C is rarely observed as the early disease is generally quite mild. (HCV HCV abbr. hepatitis C virus HCV 1 Hepatitis C virus, see there 2. Human coronavirus. See Coronavirus. ). For more information on ViroPharma, visit the company's website at http://www.viropharma.com. About Medidata Solutions Worldwide Medidata Solutions helps the world's leading pharmaceutical, biotechnology, medical device and research organizations maximize the value of their clinical research investments. Innovative process design, technology and services streamline clinical trials by providing early visibility to reliable clinical data - the lifeblood of every research organization. Working with companies and institutions both large and small, Medidata Solutions helps clinical researchers safely accelerate the process of bringing life-enhancing treatments to market - on five continents and in more than 70 countries. Medidata Solutions brings significant value to its broad client base with deep clinical experience and expertise in more than 20 therapeutic areas, projects in Phase I, II, III, IV, registries and surveillance, and studies with thousands of investigators and tens-of-thousands of subjects. For more information, please visit www.mdsol.com. |
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