{"id":233,"date":"2020-03-05T17:45:16","date_gmt":"2020-03-05T17:45:16","guid":{"rendered":"http:\/\/re.clinicalresearch.at\/leistungen\/"},"modified":"2023-02-23T11:59:27","modified_gmt":"2023-02-23T10:59:27","slug":"services","status":"publish","type":"page","link":"https:\/\/clinicalresearch.at\/en\/services\/","title":{"rendered":"SERVICES"},"content":{"rendered":"\n\n\t\t<h2>\n\t\t\tMonitoring:\n\t\t<\/h2>\n\t\t\t<ul><li>Preparation of monitoring plans and forms<\/li><li>Evaluations for risk-based monitoring<\/li><li> Study initiation<\/li><li>Monitoring and SDV<\/li><li>Drug Accountability<\/li><li>Remote Monitoring<\/li><li>Document management at the study site<\/li><li>Co-monitoring<\/li><li>Study termination \/ close-out<\/li><\/ul>\t\t\n\t\t<h2>\n\t\t\tSelection and organisation of study sites:\n\t\t<\/h2>\n\t\t\t<ul><li>Feasibility process<\/li><li>Site selection<\/li><li>Prestudy evaluation visits<\/li><li>Guidance on compilation of the study team for your study protocol<\/li><li>Preparations of the study site prior to the conclusion of the contract in order to achieve a prompt start of the study<\/li><li>Support regarding the internal site organization<br \/>(SOP&#8217;s for sites, definition of responsibilities at the site, support regarding the contract design)<\/li><\/ul>\t\t\n\t\t<h2>\n\t\t\tProject management:\n\t\t<\/h2>\n\t\t\t<ul><li>Coordination of the project and the personnel<\/li><li>Communication with international study teams<\/li><li>Ethic committees submissions<\/li><li>Submission to health authorities<\/li><li>Preparation and conclusion of contracts<\/li><li>Selection of external services (central labs, central ECG etc. &#8230;)<\/li><li>Organization of investigator meetings<\/li><li>Implementation of measures to expedite patient recruitment<\/li><li>Peparation of stdy documents<\/li><li>Preparation of Trial Master File and Investigator Site File<\/li><li>Document management and filing<\/li><li>Support of the monitor team<\/li><\/ul>\t\t\n\t\t<h2>\n\t\t\tData management:\n\t\t<\/h2>\n\t\t\t<p>In cooperation with our partners <a title=\"cmds GmbH\" href=\"http:\/\/www.cdms.at\/\" target=\"_blank\" rel=\"noopener\">CDMS GmbH<\/a> and <a href=\"https:\/\/hermesoft.at\/\">HERMESOFT<\/a>\u00a0we are able to offer data management services<br \/>based on validated and user-friendly systems (electronic or paper based CRF):<\/p><ul><li>Data Management Plan<\/li><li>Statistical Analysis Plan<\/li><li>Creation of CRF<\/li><li>Database Setup<\/li><li>Data Entry<\/li><li>Query process<\/li><li>Data Transfer<\/li><li>Statistical Analysis<\/li><li>Tables &amp; Listings<\/li><li>Study Report<\/li><\/ul>\t\t\n\t\t<h2>\n\t\t\tTrainings:\n\t\t<\/h2>\n\t\t\t<p><strong>Training of personnel in the field of:<\/strong><ul><li>GCP<\/li><li>Monitoring<\/li><li>Patient recruitment<\/li><li>Project management<ul><li>study preparation<\/li><li>study execution<\/li><li>study termination<\/li><\/ul><\/li><\/ul>We also offer project specific training for clinical studies. Training on other topics in clinical research on enquiry.<strong>Training for study sites (study coordinators, study nurses, investigators) in the field of:<\/strong>\u00a0<\/p><ul><li>GCP<\/li><li>patient recruitment<\/li><li>organization of sites<\/li><li>\u00a0<\/li><\/ul>\t\t\n\t\t<h2>\n\t\t\tQuality management:\n\t\t<\/h2>\n\t\t\t<ul><li>Implementation of quality management systems and SOP&#8217;s<br \/>(based on international Guidelines and national laws)<\/li><li>Preparation of audits and inspections<\/li><li>Execution of audits (in-house and\/or on-site)<\/li><\/ul>\t\t\n\t\t<h2>\n\t\t\tNon-interventional studies:\n\t\t<\/h2>\n\t\t\t<ul><li>Notifications to ethics committees and health authorities<\/li><li>Study support and monitoring<\/li><li>Data management<\/li><li>Analysis and reports<\/li><\/ul>\t\t\n\n","protected":false},"excerpt":{"rendered":"<p>Monitoring: Preparation of monitoring plans and forms Evaluations for risk-based monitoring Study initiation Monitoring and SDV Drug Accountability Remote Monitoring Document management at the study site Co-monitoring Study termination \/ close-out Selection and organisation of study sites: Feasibility process Site selection Prestudy evaluation visits Guidance on compilation of the study team for your study protocol&hellip;<\/p>\n","protected":false},"author":1,"featured_media":234,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-233","page","type-page","status-publish","has-post-thumbnail","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.2 - 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