{"id":6445,"date":"2019-09-05T16:13:11","date_gmt":"2019-09-05T16:13:11","guid":{"rendered":"http:\/\/www.clinres.si\/?page_id=6445"},"modified":"2026-02-18T18:32:37","modified_gmt":"2026-02-18T18:32:37","slug":"quality-assurance","status":"publish","type":"page","link":"https:\/\/www.clinres.si\/en\/services\/quality-assurance\/","title":{"rendered":"Quality assurance"},"content":{"rendered":"[vc_row type=&#8221;full_width_background&#8221; full_screen_row_position=&#8221;middle&#8221; bg_image=&#8221;6473&#8243; bg_position=&#8221;center center&#8221; bg_repeat=&#8221;no-repeat&#8221; bg_color=&#8221;#ffffff&#8221; scene_position=&#8221;center&#8221; text_color=&#8221;light&#8221; text_align=&#8221;left&#8221; top_padding=&#8221;10%&#8221; bottom_padding=&#8221;15%&#8221; color_overlay=&#8221;#000000&#8243; overlay_strength=&#8221;0.5&#8243; enable_shape_divider=&#8221;true&#8221; shape_divider_color=&#8221;#ffffff&#8221; shape_divider_position=&#8221;bottom&#8221; shape_divider_height=&#8221;100&#8243; 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column_border_width=&#8221;none&#8221; column_border_style=&#8221;solid&#8221; bg_image_animation=&#8221;none&#8221; enable_animation=&#8221;true&#8221; animation=&#8221;fade-in&#8221; offset=&#8221;vc_col-lg-6 vc_col-md-6 vc_col-xs-12&#8243;][vc_column_text css_animation=&#8221;fadeInUp&#8221; css=&#8221;.vc_custom_1567700049022{margin-bottom: 15px !important;}&#8221;]\n<h5>Services<\/h5>\n[\/vc_column_text][split_line_heading]\n<h2>Quality assurance<\/h2>\n[\/split_line_heading][\/vc_column_inner][vc_column_inner column_padding=&#8221;padding-6-percent&#8221; column_padding_position=&#8221;bottom&#8221; background_color_opacity=&#8221;1&#8243; background_hover_color_opacity=&#8221;1&#8243; column_shadow=&#8221;none&#8221; column_border_radius=&#8221;none&#8221; column_link_target=&#8221;_self&#8221; width=&#8221;1\/4&#8243; tablet_width_inherit=&#8221;default&#8221; column_border_width=&#8221;none&#8221; column_border_style=&#8221;solid&#8221; bg_image_animation=&#8221;none&#8221; enable_animation=&#8221;true&#8221; 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tab_id=&#8221;1768993508196-10&#8243;][\/page_link][page_link title=&#8221;Medical Devices Support&#8221; id=&#8221;1768993508211-5&#8243; link_url=&#8221;\/en\/services\/medical-devices-support\/&#8221; tab_id=&#8221;1768993508212-2&#8243;][\/page_link][page_link title=&#8221;Other services&#8221; id=&#8221;1768993508227-0&#8243; link_url=&#8221;\/en\/services\/other-services\/&#8221; tab_id=&#8221;1768993508228-10&#8243;][\/page_link][page_link title=&#8221;GMP\/GDP Services&#8221; id=&#8221;1768993508241-1&#8243; tab_id=&#8221;1768993508242-5&#8243; link_url=&#8221;https:\/\/www.clinres.si\/en\/services\/gmp-and-gdp-services\/&#8221;][\/page_link][\/page_submenu][\/vc_column][\/vc_row][vc_row type=&#8221;full_width_background&#8221; full_screen_row_position=&#8221;middle&#8221; scene_position=&#8221;center&#8221; text_color=&#8221;dark&#8221; text_align=&#8221;left&#8221; top_padding=&#8221;7%&#8221; bottom_padding=&#8221;7%&#8221; overlay_strength=&#8221;0.3&#8243; shape_divider_position=&#8221;bottom&#8221; bg_image_animation=&#8221;none&#8221;][vc_column column_padding=&#8221;padding-2-percent&#8221; column_padding_position=&#8221;all&#8221; background_color_opacity=&#8221;1&#8243; background_hover_color_opacity=&#8221;1&#8243; column_link_target=&#8221;_self&#8221; column_shadow=&#8221;none&#8221; column_border_radius=&#8221;none&#8221; width=&#8221;1\/2&#8243; tablet_width_inherit=&#8221;default&#8221; tablet_text_alignment=&#8221;default&#8221; phone_text_alignment=&#8221;default&#8221; column_border_width=&#8221;none&#8221; column_border_style=&#8221;solid&#8221; bg_image_animation=&#8221;none&#8221;][vc_column_text]\n<h2>Quality assurance<\/h2>\n<p class=\"lead\">We are able to provide you with a full range of independent GxP Quality Assurance Auditing, Consulting and Training for Pharmaceutical, Biotechnology and Medical Device products according to your needs.<\/p>\n<p>Our global field force ensures that there are enough staff members to get your auditing and consulting needs scheduled, conducted and reported on time and when you need them. Our leadership and project managers assure that your deliverables are there on time and of the highest quality, allowing you to get on with your own schedule.<\/p>\n<p>With the help of our in-house knowledge and our partners, we can offer you high quality service and expertise from:[\/vc_column_text][\/vc_column][vc_column column_padding=&#8221;padding-2-percent&#8221; column_padding_position=&#8221;all&#8221; background_color_opacity=&#8221;1&#8243; background_hover_color_opacity=&#8221;1&#8243; column_link_target=&#8221;_self&#8221; column_shadow=&#8221;none&#8221; column_border_radius=&#8221;none&#8221; width=&#8221;1\/2&#8243; tablet_width_inherit=&#8221;default&#8221; tablet_text_alignment=&#8221;default&#8221; phone_text_alignment=&#8221;default&#8221; column_border_width=&#8221;none&#8221; column_border_style=&#8221;solid&#8221; bg_image_animation=&#8221;none&#8221;][toggles style=&#8221;minimal&#8221;][toggle color=&#8221;Accent-Color&#8221; title=&#8221;Good Clinical Practice&#8221;][vc_column_text]\n<h4>GCP Audits<\/h4>\n<ul>\n<li>CRO &amp;\/or SMO Vendors<\/li>\n<li>Internal Systems (Clin-Ops, DM, MW, etc\u2026)<\/li>\n<li>Specialty Service Providers (imaging, ECG, IRB\/EC, etc\u2026)<\/li>\n<li>Phase I clinical study audits, including BA\/BE studies<\/li>\n<li>Phase II to IV clinical study<\/li>\n<li>Safety Systems &amp; Vendors<\/li>\n<li>Document audits: protocols, ICF, IB, CRF, CSRs, submissions, etc\u2026<\/li>\n<li>Clinical Database audits<\/li>\n<li>Data Management &amp; Biostatistics audits<\/li>\n<li>IVRS audit<\/li>\n<li>Management of audit programs for Phase III studies and mega-trials<\/li>\n<li>Clinical trial supply service providers<\/li>\n<li>FDA and\/or EMA Mock Inspections<\/li>\n<li>Trial master files (TMF) for regulatory submission<\/li>\n<\/ul>\n[\/vc_column_text][\/toggle][toggle color=&#8221;Default&#8221; title=&#8221;Good Pharmacovigilance Practices&#8221;][vc_column_text]<strong>Pharmacovigilance Audits<\/strong><\/p>\n<ul>\n<li>Clinical Safety<\/li>\n<li>Post-Marketing Safety<\/li>\n<li>Internal Full PV &amp; Drug Safety Systems<\/li>\n<li>Company Affiliates<\/li>\n<li>Vendors (US, EU, Japan, etc\u2026)<\/li>\n<li>Marketing &amp; License Partners<\/li>\n<li>Product Distributors &amp; Warehousing<\/li>\n<li>Call Centers<\/li>\n<li>Document audits: PSURs, DSURs, Contracts &amp; SDEA, RMPs, etc\u2026<\/li>\n<li>Safety Database Validation<\/li>\n<li>Submissions &amp; 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