Harrison Clinical starts Phase III clinical trial with MARVIN
Harrison Clinical Research is a global full-service CRO that meets the highest international standards. HCR has licensed MARVIN, XClinical’s EDC-CDM System non-exclusively. In April 2006 a pivotal phase III vaccine study started, involving the screening of 1600 subjects with the objective to include 800 individuals into the study. HCR has set up the study in MARVIN and has created the e-CRF, based on the international CDISC ODM Standard, in a record period of time.XClinical Professional Services provides technical support, the server hardware and the validated hosting environment so that HCR saves operating expense and staff in IT system administration. Thus XClinical ensures a smooth technical workflow. HCR provides for the direct maintenance of the e-CRF, the first level support for the sites, the continuous data management and the statistical evaluation of the clinical trial.
Harrison Clinical Research (www.harrisonclinical.com) provides support for all phases of clinical development and registration of new pharmaceutical products and medical devices from Phase I (Phases I and IIa in HCR ’s own clinics) to Phase IV, Monitoring, Biostatistics and Data Management, Medical Writing, Auditing and Training. HCR´s Quality Management System was awarded the ISO 9001 certification in March 1998. HCR is one of the few Clinical Research Organisations (CROs) that have achieved this. It was updated to ISO 9001:2000 in January 2002 and was renewed again in April 2004.
XClinical GmbH (www.xclinical.com) is a modern and professional Munich-based EDC vendor for all types of clinical studies. The company develops and distributes MARVIN, an Internet-based Software for Electronic Data Capture (EDC), Clinical Data Management (CDM) and Clinical Trial Management (CTM).
More and more pharmaceutical and biotechnology companies, but also medical devices manufacturers are using MARVIN, the data of more than 25,000 patients in 26 simultaneous studies have been documented until today.
Eva Boscher, XClinical GmbH, Phone: 089 / 452277-5210, Email: press@xclinical.com
Joachim Klinger, Harrison Clinical Research GmbH, Phone: +49 - 89 / 126680-2190,
Email: jklinger@harrison-cro.com
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