{"id":97,"date":"2021-03-24T09:41:35","date_gmt":"2021-03-24T08:41:35","guid":{"rendered":"http:\/\/www.meliora-compliance.com\/?page_id=97"},"modified":"2023-09-20T21:13:44","modified_gmt":"2023-09-20T19:13:44","slug":"regulatory-partner-for-clinical-study-approval","status":"publish","type":"page","link":"https:\/\/www.meliora-compliance.com\/czech\/regulatory-partner-for-clinical-study-approval\/","title":{"rendered":"Regulatorn\u00ed podpora klinick\u00fdch zkou\u0161ek"},"content":{"rendered":"<div data-elementor-type=\"wp-page\" data-elementor-id=\"97\" class=\"elementor elementor-97\">\n\t\t\t\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-3b1e0021 elementor-section-height-min-height elementor-section-boxed elementor-section-height-default elementor-section-items-middle\" data-id=\"3b1e0021\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;shape_divider_bottom&quot;:&quot;triangle&quot;,&quot;shape_divider_bottom_negative&quot;:&quot;yes&quot;}\">\n\t\t\t\t\t<div class=\"elementor-shape elementor-shape-bottom\" data-negative=\"true\">\n\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewbox=\"0 0 1000 100\" preserveaspectratio=\"none\">\n\t<path class=\"elementor-shape-fill\" d=\"M500.2,94.7L0,0v100h1000V0L500.2,94.7z\"\/>\n<\/svg>\t\t<\/div>\n\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-4f494e20\" data-id=\"4f494e20\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-3203e49b elementor-widget__width-initial elementor-widget-tablet__width-initial elementor-widget elementor-widget-image\" data-id=\"3203e49b\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"300\" height=\"300\" src=\"https:\/\/www.meliora-compliance.com\/wp-content\/uploads\/2023\/08\/06_CLINICAL-APPROVAL-300x300.png\" class=\"elementor-animation-push attachment-medium size-medium wp-image-826\" alt=\"\" srcset=\"https:\/\/www.meliora-compliance.com\/wp-content\/uploads\/2023\/08\/06_CLINICAL-APPROVAL-300x300.png 300w, https:\/\/www.meliora-compliance.com\/wp-content\/uploads\/2023\/08\/06_CLINICAL-APPROVAL-150x150.png 150w, https:\/\/www.meliora-compliance.com\/wp-content\/uploads\/2023\/08\/06_CLINICAL-APPROVAL-12x12.png 12w, https:\/\/www.meliora-compliance.com\/wp-content\/uploads\/2023\/08\/06_CLINICAL-APPROVAL.png 512w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-7c828caa\" data-id=\"7c828caa\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-4c0b218a elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"4c0b218a\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Regulatorn\u00ed podpora klinick\u00fdch zkou\u0161ek<\/h1>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-5a4d8767 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"5a4d8767\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-1da841df\" data-id=\"1da841df\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-5b59ec2e elementor-widget elementor-widget-heading\" data-id=\"5b59ec2e\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Pro\u010d podpora v\u00fdvoje?<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f70f4d2 elementor-widget elementor-widget-text-editor\" data-id=\"f70f4d2\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">Klinick\u00e9 studie a n\u00e1sledn\u00e9 klinick\u00e9 sledov\u00e1n\u00ed jsou nezbytn\u00e9 pro vstup na trh i pro dlouhodob\u00e9 udr\u017een\u00ed z\u00e1konn\u00e9ho schv\u00e1len\u00ed va\u0161eho zdravotnick\u00e9ho prost\u0159edku.<\/span><\/p><p><span style=\"font-weight: 400;\">Pokud pl\u00e1nujete b\u00fdt sponzorem klinick\u00e9 studie (klinick\u00e9 zkou\u0161ky), nebo pokud jste v\u00fdrobcem prost\u0159edku, kter\u00fd je ji\u017e na trhu, Meliora Compliance v\u00e1m poskytne nezbytnou regulatorn\u00ed podporu pro spln\u011bn\u00ed po\u017eadavk\u016f na klinick\u00e9 zkou\u0161ky konan\u00e9 p\u0159ed i po uveden\u00ed na trh, jak je pops\u00e1no ve Spr\u00e1vn\u00e9 klinick\u00e9 praxi (GCP), evropsk\u00fdch z\u00e1konech EU MDR (2017\/745 \/ EU) a IVDR (2017\/746), US FDA z\u00e1kon\u011b, mezin\u00e1rodn\u00ed norm\u011b ISO 14155 a pravidlech m\u00edstn\u00edch p\u0159\u00edslu\u0161n\u00fdch org\u00e1n\u016f.<\/span><\/p><p><span style=\"font-weight: 400;\">Nab\u00edz\u00edme v\u00e1m tyto slu\u017eby<\/span><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-44e7d042 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"44e7d042\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-21ef3709\" data-id=\"21ef3709\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-122c4ebc elementor-widget elementor-widget-text-editor\" data-id=\"122c4ebc\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Poskytneme v\u00e1m podporu p\u0159i slad\u011bn\u00ed va\u0161\u00ed regulatorn\u00ed a klinick\u00e9 strategie<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Budeme v\u00e1s podporovat p\u0159i nastaven\u00ed modulu klinick\u00fdch z\u00e1le\u017eitost\u00ed va\u0161eho syst\u00e9mu \u0159\u00edzen\u00ed kvality (QMS) a p\u0159i vytv\u00e1\u0159en\u00ed va\u0161ich standardn\u00edch opera\u010dn\u00edch p\u0159edpis\u016f pro klinick\u00e9 hodnocen\u00ed a zkou\u0161ky v souladu s ISO 13485 nebo US FDA 21 CFR 820<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Budeme v\u00e1s podporovat p\u0159i vytv\u00e1\u0159en\u00ed zpr\u00e1vy o klinick\u00e9m hodnocen\u00ed (CER) v souladu s pokyny EU MEDDEV 2.7 \/ 1 nebo jin\u00fdmi p\u0159\u00edslu\u0161n\u00fdmi dokumenty<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Budeme v\u00e1s podporovat p\u0159i v\u00fdb\u011bru vhodn\u00e9 agentury pro klinick\u00fd v\u00fdzkum (CRO) pro va\u0161i studii<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Budeme se \u00fa\u010dastnit prvn\u00edch sch\u016fzek s va\u0161\u00edm ozn\u00e1men\u00fdm subjektem (notified body), americk\u00fdm \u00fa\u0159adem FDA a dal\u0161\u00edmi regulatorn\u00edmi org\u00e1ny, abychom prodiskutovali va\u0161i klinickou strategii pro budouc\u00ed schv\u00e1len\u00ed pro prodej<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">P\u0159iprav\u00edme p\u0159edb\u011b\u017enou \u017e\u00e1dost (pre-submission) americk\u00e9mu \u00fa\u0159adu FDA, abychom z\u00edskali zp\u011btnou vazbu k nastaven\u00ed va\u0161\u00ed pl\u00e1novan\u00e9 klinick\u00e9 zkou\u0161ky v USA<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">P\u0159iprav\u00edme va\u0161e \u017e\u00e1dosti o klinick\u00e9 studie ke schv\u00e1len\u00ed etick\u00fdmi v\u00fdbory a p\u0159\u00edslu\u0161n\u00fdmi org\u00e1ny, v\u010detn\u011b pod\u00e1n\u00ed \u017e\u00e1dosti IDE (Investigational Device Exemption) americk\u00e9mu \u00fa\u0159adu FDA<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Budeme v\u00e1s podporovat p\u0159i vytv\u00e1\u0159en\u00ed z\u00e1kladn\u00edch regulatorn\u00edch dokument\u016f pro va\u0161e studie: Souboru informac\u00ed pro zkou\u0161ej\u00edc\u00edho (IB), Protokolu o klinick\u00e9 zkou\u0161ce (CIP), Informovan\u00e9m souhlasu (ICF), Informac\u00edch o pacientovi (CRF), zpr\u00e1v\u011b o klinick\u00e9 studii a dal\u0161\u00edch dokumentech<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">U prost\u0159edk\u016f, kter\u00e9 jsou ji\u017e na trhu EU, v\u00e1s podpo\u0159\u00edme p\u0159i vytv\u00e1\u0159en\u00ed regulatorn\u00edch v\u00fdstup\u016f pot\u0159ebn\u00fdch pro va\u0161e n\u00e1sledn\u00e9 klinick\u00e9 sledov\u00e1n\u00ed po uveden\u00ed na trh (PMCF), abyste z\u00edskali dal\u0161\u00ed klinick\u00e9 informace o va\u0161em produktu s ozna\u010den\u00edm CE<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Zaregistrujeme va\u0161i studii na port\u00e1le ClinicalTrials.gov<\/span><\/li><\/ul>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-744aa954 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"744aa954\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-2bb32f87\" data-id=\"2bb32f87\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-5a59917f elementor-widget elementor-widget-heading\" data-id=\"5a59917f\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-medium\">Dotazy?<br>\nNapi\u0161te n\u00e1m!<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4de7605 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"4de7605\" data-element_type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-md\" href=\"https:\/\/www.meliora-compliance.com\/czech\/contact-us\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon elementor-align-icon-right\">\n\t\t\t\t<i aria-hidden=\"true\" class=\"fas fa-long-arrow-alt-right\"><\/i>\t\t\t<\/span>\n\t\t\t\t\t\t<span class=\"elementor-button-text\">Kontakt<\/span>\n\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>Regulatory partner for clinical study Why regulatory support? Clinical studies and post-market clinical follow-up activities are essential for market entrance, as well as for the long-term maintenance of your medical device regulatory approval. If you plan to be a sponsor of a pre-market clinical study (investigation), or if you are a manufacturer of a device &#8230; <a title=\"Regulatorn\u00ed podpora klinick\u00fdch zkou\u0161ek\" class=\"read-more\" href=\"https:\/\/www.meliora-compliance.com\/czech\/regulatory-partner-for-clinical-study-approval\/\" aria-label=\"V\u00edce na Regulatory partner for clinical study approval\">\u010c\u00edst d\u00e1l<\/a><\/p>","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"footnotes":""},"class_list":["post-97","page","type-page","status-publish"],"_links":{"self":[{"href":"https:\/\/www.meliora-compliance.com\/czech\/wp-json\/wp\/v2\/pages\/97","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.meliora-compliance.com\/czech\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.meliora-compliance.com\/czech\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.meliora-compliance.com\/czech\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.meliora-compliance.com\/czech\/wp-json\/wp\/v2\/comments?post=97"}],"version-history":[{"count":56,"href":"https:\/\/www.meliora-compliance.com\/czech\/wp-json\/wp\/v2\/pages\/97\/revisions"}],"predecessor-version":[{"id":1441,"href":"https:\/\/www.meliora-compliance.com\/czech\/wp-json\/wp\/v2\/pages\/97\/revisions\/1441"}],"wp:attachment":[{"href":"https:\/\/www.meliora-compliance.com\/czech\/wp-json\/wp\/v2\/media?parent=97"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}