The Clinical Trial Centre Wuerzburg (CTCW) at the University Hospital Wuerzburg is an academic full-service CROo and provides resources for project management, quality management, clinical monitoring, data management, database development (including access to a clinical database), pharmacovigilance, data analysis, and is part of the sponsor quality assurance for clinical trials of all phases.
The CTCW consists of a multidisciplinary team of project managers, clinical research associates, study nurses, biostaticians, and data managers with experience across many therapeutic areas and is closely cooperating with the Institute of Clinical Epidemiology and Biometry (ICE-B) at the University of Wuerzburg to ensure up-to-date methodological scientific support in terms of bio-statistics and data management.
The CTCW is involved in national and international multicenter clinical trials in numerous medical areas and supported by many different funding organisations, e.g. the German Federal Ministry of Research and Education, the German Research Foundation, the Federal Institute for Drugs and Medical Device, the 7th Framework Programme for Research and Technological Development, the University of Oxford /Merck Sharp & Dohme Corp., and the German Cancer Aid.
The CTCW will ensure a successful start-up, execution and completion of the main trial in cooperation with the overall project coordination (WP1) and in collaboration with the national trial coordinating centres (NCCs) of the participating countries. The approval from national and institutional review boards is essential for the start of a clinical trial.
The CTCW will be responsible to fulfil such regulatory requirements for sites in Germany and Austria and will support the NCCs in other countries. The CTCW will design the corresponding case report forms for the PRESTIGE-AF main trial. All clinical data will be collected, evaluated and reported. This requires a validated database system which will be developed by the CTCW. Furthermore the CTCW will coordinate the monitoring activities, prepare a monitoring plan, corresponding checklists, monitoring reports, and will be responsible for reviewing and documenting the reports in compliance with Good Clinical Practice guidelines.
The CTCW will perform clinical monitoring of the trial sites in Germany and Austria and overlook the monitoring progress of all other countries involved. A safety management plan will be developed by the CTCW to assess safety on a regular basis. The CTCW will design the Statistical Analysis Plan and perform the final statistical analyses of the collected clinical data.
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