{"id":7719,"date":"2020-06-01T13:57:17","date_gmt":"2020-06-01T13:57:17","guid":{"rendered":"https:\/\/www.kolabtree.com\/blog\/?p=7719"},"modified":"2020-06-01T13:57:17","modified_gmt":"2020-06-01T13:57:17","slug":"what-to-look-for-in-a-medical-device-cro","status":"publish","type":"post","link":"https:\/\/www.kolabtree.com\/blog\/ja\/what-to-look-for-in-a-medical-device-cro\/","title":{"rendered":"\u533b\u7642\u6a5f\u5668CRO\u306b\u6c42\u3081\u3089\u308c\u308b\u3082\u306e"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_45_1 counter-flat ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\">table of contents<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" area-label=\"ez-toc-toggle-icon-1\"><label for=\"item-69f24b9d3eb7d\" aria-label=\"Table of Content\"><span style=\"display: flex;align-items: center;width: 35px;height: 30px;justify-content: center;direction:ltr;\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewbox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewbox=\"0 0 24 24\" version=\"1.2\" baseprofile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/label><input  type=\"checkbox\" id=\"item-69f24b9d3eb7d\"><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1' ><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/what-to-look-for-in-a-medical-device-cro\/#The_right_expertise\" title=\"\u9069\u5207\u306a\u5c02\u9580\u77e5\u8b58\u00a0\">\u9069\u5207\u306a\u5c02\u9580\u77e5\u8b58\u00a0<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/what-to-look-for-in-a-medical-device-cro\/#Transparency\" title=\"\u900f\u660e\u6027\u00a0\">\u900f\u660e\u6027\u00a0<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/what-to-look-for-in-a-medical-device-cro\/#Experience_with_regulatory_requirements\" title=\"\u898f\u5236\u8981\u4ef6\u306b\u95a2\u3059\u308b\u7d4c\u9a13\u00a0\">\u898f\u5236\u8981\u4ef6\u306b\u95a2\u3059\u308b\u7d4c\u9a13\u00a0<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/what-to-look-for-in-a-medical-device-cro\/#When_you_should_work_with_independent_medical_device_consultants\" title=\"\u72ec\u7acb\u3057\u305f\u533b\u7642\u6a5f\u5668\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8\u3068\u5354\u529b\u3059\u3079\u304d\u5834\u5408\u00a0\">\u72ec\u7acb\u3057\u305f\u533b\u7642\u6a5f\u5668\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8\u3068\u5354\u529b\u3059\u3079\u304d\u5834\u5408\u00a0<\/a><\/li><\/ul><\/nav><\/div>\n<p><i><span style=\"font-weight: 400;\">Outsourcing clinical <a href=\"https:\/\/www.kolabtree.com\/blog\/ja\/ensuring-reproducibility-in-ai-driven-research-how-freelance-experts-can-help-in-biotech-and-healthcare\/\">\u30ea\u30b5\u30fc\u30c1<\/a> to a medical device CRO can be a good decision for small medical device businesses. Here\u2019s what to look for while hiring a medical device CRO or <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/medical-device?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDCRO\">\u533b\u7642\u6a5f\u5668\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8<\/a>.\u00a0<\/span><\/i><\/p>\n<p><span style=\"font-weight: 400;\">\u4e2d\u5c0f\u898f\u6a21\u306e\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u81e8\u5e8a\u7814\u7a76\u306e\u8907\u96d1\u3055\u3092\u3059\u3079\u3066\u51e6\u7406\u3067\u304d\u308b\u30d5\u30eb\u30bf\u30a4\u30e0\u306e\u30c1\u30fc\u30e0\u3092\u96c7\u3046\u3060\u3051\u306e\u30ea\u30bd\u30fc\u30b9\u3092\u6301\u3063\u3066\u3044\u306a\u3044\u3053\u3068\u304c\u3088\u304f\u3042\u308a\u307e\u3059\u3002\u898f\u5236\u8981\u4ef6\u3001\u502b\u7406\u7684\u914d\u616e\u3001\u898f\u5236\u5f53\u5c40\u306e\u627f\u8a8d\u3078\u306e\u30eb\u30fc\u30c8\u3001\u6280\u8853\u6587\u66f8\u306a\u3069\u3001\u3053\u308c\u3089\u3059\u3079\u3066\u304c\u81e8\u5e8a\u8a66\u9a13\u30d7\u30ed\u30bb\u30b9\u306e\u91cd\u8981\u306a\u90e8\u5206\u3092\u5f62\u6210\u3057\u3066\u3044\u307e\u3059\u3002\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306f\u3001\u81e8\u5e8a\u8a66\u9a13\u3092\u6210\u529f\u3055\u305b\u305f\u5b9f\u7e3e\u304c\u3042\u308a\u3001\u7570\u306a\u308b\u5730\u57df\u306e\u6700\u65b0\u306e\u898f\u5236\u306b\u5bfe\u5fdc\u3057\u3066\u3044\u308bCRO\u3092\u9078\u629e\u3059\u308b\u3053\u3068\u304c\u91cd\u8981\u3067\u3059\u3002\u4ee5\u4e0b\u306f\u3001\u30a2\u30a6\u30c8\u30bd\u30fc\u30b7\u30f3\u30b0\u306e\u969b\u306b\u898b\u308b\u3079\u304d3\u3064\u306e\u30dd\u30a4\u30f3\u30c8\u3067\u3059\u3002 <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/clinical-trials?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDCRO\">\u81e8\u5e8a\u7814\u7a76<\/a> \u3092CRO\u306b\u63d0\u4f9b\u3057\u3066\u3044\u307e\u3059\u3002\u00a0<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"The_right_expertise\"><\/span><strong>\u9069\u5207\u306a\u5c02\u9580\u77e5\u8b58\u00a0<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">\u7814\u7a76\u7528\u306eCRO\u3092\u9078\u3076\u969b\u306b\u306f\u3001\u533b\u7642\u6a5f\u5668\u306b\u7279\u5316\u3057\u305f\u7d4c\u9a13\u3092\u6301\u3064CRO\u3092\u9078\u3073\u307e\u3057\u3087\u3046\u3002\u305d\u306eCRO\u306f\u3055\u307e\u3056\u307e\u306a\u30af\u30e9\u30b9\u306e\u533b\u7642\u6a5f\u5668\u3092\u6271\u3063\u3066\u3044\u307e\u3059\u304b\uff1f\u7279\u5b9a\u306e\u30af\u30e9\u30b9\u306e\u533b\u7642\u6a5f\u5668\u3084\u7279\u5b9a\u306e\u6cbb\u7642\u5206\u91ce\u306b\u7279\u5316\u3057\u3066\u3044\u307e\u3059\u304b\uff1f\u00a0 <\/span><\/p>\n<p><span style=\"font-weight: 400;\"><a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/shrinidh-joshi\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDCRO\">Shrinidh Joshi,<\/a> \u81e8\u5e8a\u7814\u7a76\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8\u3068 <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/medical-writing\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDCRO\">\u30d5\u30ea\u30fc\u30e9\u30f3\u30b9\u306e\u30e1\u30c7\u30a3\u30ab\u30eb\u30e9\u30a4\u30bf\u30fc<\/a>\u00a0\u306eKolabtree\u6c0f\u306f\u3001\u300c\u591a\u304f\u306eCRO\u306f\u88fd\u85ac\u306b\u7279\u5316\u3057\u3066\u304a\u308a\u3001\u533b\u7642\u6a5f\u5668\u306e\u8a66\u9a13\u7d4c\u9a13\u304c\u5341\u5206\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306f\u3001CRO\u306e\u8a55\u4fa1\u30d7\u30ed\u30bb\u30b9\u306e\u65e9\u3044\u6bb5\u968e\u3067\u3053\u306e\u4e8b\u5b9f\u3092\u78ba\u8a8d\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u88fd\u85ac\u4f1a\u793e\u3068\u533b\u7642\u6a5f\u5668\u306e\u81e8\u5e8a\u8a66\u9a13\u3092\u904b\u55b6\u3059\u308b\u4e0a\u3067\u306e\u4e2d\u6838\u7684\u306a\u904b\u55b6\u9762\u306f\u540c\u3058\u3067\u3059\u304c\u3001\u5927\u304d\u306a\u9055\u3044\u3082\u3042\u308a\u307e\u3059\u3002\u3082\u3057CRO\u304c\u4e3b\u306b\u88fd\u85ac\u4f1a\u793e\u306e\u81e8\u5e8a\u8a66\u9a13\u3092\u6271\u3063\u3066\u3044\u308b\u306e\u3067\u3042\u308c\u3070\u3001\u5f7c\u3089\u306e\u5c02\u9580\u6027\u306f\u533b\u7642\u6a5f\u5668\u306e\u5206\u91ce\u3067\u306f\u306a\u3044\u53ef\u80fd\u6027\u304c\u9ad8\u3044\u3067\u3059\u3002\"\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306f\u3001CRO\u306b\u4e00\u822c\u7684\u306a\u533b\u7642\u6a5f\u5668\u8a66\u9a13\u306e\u7d4c\u9a13\u4ee5\u4e0a\u306e\u3082\u306e\u3092\u6c42\u3081\u308b\u3079\u304d\u3067\u3059\u3002\u533b\u7642\u6a5f\u5668\u306e\u81e8\u5e8a\u8a66\u9a13\u306e\u305f\u3081\u306e\u7406\u60f3\u7684\u306a\u30d9\u30f3\u30c0\u30fc\u306f\u3001\u305d\u306e\u88fd\u54c1\u306e\u6cbb\u7642\u9818\u57df\u3068\u7279\u5b9a\u306e\u9069\u5fdc\u75c7\u306e\u305f\u3081\u306e\u81e8\u5e8a\u7814\u7a76\u3092\u5b9f\u65bd\u3059\u308b\u3053\u3068\u306b\u6210\u529f\u3057\u3066\u3044\u307e\u3059\u3002\u3082\u3057\u305d\u306eCRO\u304c\u3001\u3042\u306a\u305f\u306e\u30c7\u30d0\u30a4\u30b9\u3084\u30d7\u30ec\u30c7\u30a3\u30b1\u30fc\u30c8\u306b\u985e\u4f3c\u3057\u305f\u88fd\u54c1\u30c7\u30b6\u30a4\u30f3\u3084\u30c7\u30d0\u30a4\u30b9\u3092\u624b\u304c\u3051\u305f\u3053\u3068\u304c\u3042\u308c\u3070\u3001\u305d\u308c\u306f\u7406\u60f3\u7684\u306aCRO\u3068\u8a00\u3048\u308b\u3067\u3057\u3087\u3046\u3002\"\u00a0<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Transparency\"><\/span><strong>\u900f\u660e\u6027\u00a0<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">\u8aa0\u5b9f\u306a\u30b3\u30df\u30e5\u30cb\u30b1\u30fc\u30b7\u30e7\u30f3\u3068\u900f\u660e\u6027\u304c\u3001\u826f\u597d\u306a\u5354\u529b\u95a2\u4fc2\u306e\u9375\u3067\u3059\u3002Shrinidh\u6c0f\u306f\u3001\u300cCRO\u3068\u4ed5\u4e8b\u3092\u3057\u3066\u3044\u308b\u3068\u3001\u8a55\u4fa1\u6bb5\u968e\u304b\u3089\u30b9\u30dd\u30f3\u30b5\u30fc\uff08\u533b\u7642\u6a5f\u5668\u4f01\u696d\uff09\u3068\u30d9\u30f3\u30c0\u30fc\uff08CRO\uff09\u306e\u95a2\u4fc2\u306b\u304a\u3044\u3066\u3001\u53cc\u65b9\u306e\u900f\u660e\u6027\u3001\u4fe1\u983c\u3001\u8aa0\u5b9f\u3055\u3001\u30b3\u30df\u30e5\u30cb\u30b1\u30fc\u30b7\u30e7\u30f3\u306e\u91cd\u8981\u6027\u3092\u5f37\u8abf\u3057\u305f\u304f\u306a\u308a\u307e\u3059\u300d\u3068\u63a8\u5968\u3057\u3066\u3044\u307e\u3059\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u300c\u30b9\u30dd\u30f3\u30b5\u30fc\u306f\u3001\u5951\u7d04\u304b\u3089\u4f55\u3092\u5fc5\u8981\u3068\u3057\u3066\u3044\u308b\u306e\u304b\u3001\u6210\u529f\u3068\u5931\u6557\u306e\u5b9a\u7fa9\u306f\u4f55\u304b\u3001\u3069\u306e\u304f\u3089\u3044\u306e\u4e88\u7b97\u304c\u3042\u308b\u306e\u304b\u3001\u3069\u306e\u304f\u3089\u3044\u306e\u671f\u9593\u304c\u304b\u304b\u308b\u3068\u4e88\u60f3\u3057\u3066\u3044\u308b\u306e\u304b\u306b\u3064\u3044\u3066\u3001CRO\u3068\u7387\u76f4\u306b\u8a71\u3057\u5408\u3046\u3079\u304d\u3067\u3059\u3002\u30b9\u30dd\u30f3\u30b5\u30fc\u306f\u3001\u81ea\u793e\u306e\u80fd\u529b\uff08\u307e\u305f\u306f\u305d\u306e\u4e0d\u8db3\uff09\u306b\u3064\u3044\u3066\u6b63\u76f4\u306b\u8a71\u3059\u3079\u304d\u3067\u3059\u3002\u307e\u305f\u3001\u30b9\u30dd\u30f3\u30b5\u30fc\u304c\u4eca\u5f8c\u306e\u6226\u7565\u7684\u30a2\u30d7\u30ed\u30fc\u30c1\u3092\u4f1d\u3048\u308b\u3053\u3068\u306f\u3001\u81e8\u5e8a\u3060\u3051\u3067\u306a\u304f\u8ca9\u58f2\u3084\u5546\u696d\u9762\u3067\u3082\u6709\u76ca\u3067\u3059\u3002\u533b\u7642\u6a5f\u5668\u696d\u754c\u3067\u306f\u3001\u81e8\u5e8a\u8a66\u9a13\u306e\u74b0\u5883\u304c\u6bd4\u8f03\u7684\u65b0\u3057\u3044\u305f\u3081\u3001\u30b9\u30dd\u30f3\u30b5\u30fc\u304cCRO\u3084\u30d9\u30f3\u30c0\u30fc\u3068\u9577\u671f\u7684\u306a\u6226\u7565\u3001\u5546\u696d\u6226\u7565\u3001\u30de\u30cd\u30fc\u30b8\u30c9\u30b1\u30a2\u6226\u7565\u3092\u5171\u6709\u3059\u308b\u3053\u3068\u306b\u5fc5\u305a\u3057\u3082\u62b5\u6297\u304c\u306a\u3044\u306e\u304b\u3082\u3057\u308c\u307e\u305b\u3093\u3002\u3057\u304b\u3057\u3001\u79c1\u306f\u5185\u90e8\u306e\u4eba\u9593\u3068\u3057\u3066\u3001\u30d9\u30f3\u30c0\u30fc\u304c\u30b9\u30dd\u30f3\u30b5\u30fc\u306e\u9577\u671f\u6226\u7565\u3092\u7406\u89e3\u3059\u308b\u3053\u3068\u306f\u975e\u5e38\u306b\u91cd\u8981\u3067\u3042\u308b\u3068\u8a00\u3048\u307e\u3059\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u300c\u4e00\u65b9\u3001\u30b9\u30dd\u30f3\u30b5\u30fc\u306f\u3001\u5177\u4f53\u7684\u306a\u80fd\u529b\u3001\u5f97\u610f\u5206\u91ce\u3068\u4e0d\u5f97\u610f\u5206\u91ce\u3001\u63d0\u4f9b\u3055\u308c\u308b\u5177\u4f53\u7684\u306a\u30b5\u30fc\u30d3\u30b9\u3001\u30b3\u30b9\u30c8\u306a\u3069\u306b\u3064\u3044\u3066\u7387\u76f4\u306b\u8aac\u660e\u3057\u3066\u304f\u308c\u308b\u30d9\u30f3\u30c0\u30fc\u3092\u9078\u3076\u3079\u304d\u3067\u3059\u3002\u533b\u7642\u6a5f\u5668\u306e\u81e8\u5e8a\u8a66\u9a13\u3092\u6210\u529f\u3055\u305b\u308b\u305f\u3081\u306b\u306f\u3001\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u3068CRO\u306e\u9069\u5207\u306a\u9023\u643a\u304c\u91cd\u8981\u3067\u3059\u3002CRO\u3068\u5354\u529b\u7684\u3067\u76f8\u4e92\u5c0a\u91cd\u306e\u95a2\u4fc2\u3092\u7bc9\u304f\u3053\u3068\u3067\u5f97\u3089\u308c\u308b\u30e1\u30ea\u30c3\u30c8\u306f\u5927\u304d\u3044\u3067\u3057\u3087\u3046\u3002\"\u00a0<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Experience_with_regulatory_requirements\"><\/span><strong>\u898f\u5236\u8981\u4ef6\u306b\u95a2\u3059\u308b\u7d4c\u9a13\u00a0<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">CRO\u3092\u9078\u3076\u969b\u306b\u306f\u3001\u81e8\u5e8a\u7814\u7a76\u306b\u95a2\u308f\u308b\u898f\u5236\u8981\u4ef6\u3084\u502b\u7406\u898f\u5247\u306e\u5c02\u9580\u5bb6\u3067\u3042\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u3053\u3068\u304c\u91cd\u8981\u3067\u3059\u3002\u6b27\u5dde\u3067\u306f\u3001\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306f\u533b\u7642\u6a5f\u5668\u898f\u5247\u3092\u9075\u5b88\u3057\u3001\u88fd\u54c1\u3092EU\u5e02\u5834\u306b\u6295\u5165\u3059\u308b\u3053\u3068\u3092\u8a31\u53ef\u3059\u308bCE\u30de\u30fc\u30af\u3092\u53d6\u5f97\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u306e\u30d7\u30ed\u30bb\u30b9\u3067\u306f\u3001\u81e8\u5e8a\u8a55\u4fa1\u304c\u91cd\u8981\u306a\u5f79\u5272\u3092\u679c\u305f\u3057\u3066\u3044\u307e\u3059\u304c\u3001\u305d\u306e\u305f\u3081\u306b\u306fCE\u30de\u30fc\u30af\u306e\u7dad\u6301\u30fb\u66f4\u65b0\u304c\u4e0d\u53ef\u6b20\u3067\u3059\u3002 <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/clinical-evaluation-report-cer\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDCRO\">\u81e8\u5e8a\u8a55\u4fa1\u5831\u544a\u66f8<\/a> \u307e\u305f\u306fCER\u306e\u4f5c\u6210\u304c\u7fa9\u52d9\u4ed8\u3051\u3089\u308c\u3066\u3044\u307e\u3059\u3002MDR\u306f\u307e\u3060\u65b0\u3057\u304f\u3001\u5177\u4f53\u7684\u306b\u4f55\u304c\u6c42\u3081\u3089\u308c\u3066\u3044\u308b\u306e\u304b\u4e0d\u660e\u306a\u70b9\u3082\u3042\u308b\u305f\u3081\u3001\u7279\u306b\u65b0\u3057\u3044\u898f\u5236\u306b\u6cbf\u3063\u305fCER\u306e\u4f5c\u6210\u7d4c\u9a13\u306e\u3042\u308b\u5c02\u9580\u5bb6\u3068\u5354\u529b\u3059\u308b\u3053\u3068\u304c\u91cd\u8981\u3067\u3042\u308b\u3002\u7c73\u56fd\u3067\u306f <a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/clinical-trials-guidance-documents\">FDA<\/a> \u306f\u3001\u81e8\u5e8a\u7814\u7a76\u306e\u5074\u9762\u3092\u898f\u5b9a\u3057\u3066\u3044\u307e\u3059\u3002\u3059\u3079\u3066\u306e\u81e8\u5e8a\u8a66\u9a13\u306f <a href=\"https:\/\/www.kolabtree.com\/blog\/how-to-write-a-clinical-trial-protocol\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDCRO\">IRB\u306e\u627f\u8a8d\u3092\u5f97\u308b\u305f\u3081\u306b\u5fc5\u8981\u306a<\/a>\u306f\u3001\u81e8\u5e8a\u8a66\u9a13\u30d7\u30ed\u30c8\u30b3\u30eb\u3092\u5be9\u67fb\u3057\u3001\u8a66\u9a13\u304c\u502b\u7406\u7684\u914d\u616e\u3092\u6e80\u305f\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3057\u307e\u3059\u3002FDA\u306e\u627f\u8a8d\u7d4c\u8def\u3001\u6280\u8853\u6587\u66f8\u3001\u81e8\u5e8a\u8a66\u9a13\u30d7\u30ed\u30c8\u30b3\u30eb\u3001\u8a66\u9a13\u5b9f\u65bd\u306e\u305f\u3081\u306e\u56fd\u969b\u7684\u306a\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u7cbe\u901a\u3057\u305f\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8\u306b\u4f9d\u983c\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u307e\u305f\u3001\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8\u304c\u904e\u53bb\u306b\u624b\u304c\u3051\u305f\u533b\u7642\u6a5f\u5668\u306e\u81e8\u5e8a\u8a66\u9a13\u306e\u4f8b\u3092\u5fc5\u305a\u5c0b\u306d\u3001\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8\u304c\u63d0\u4f9b\u3059\u308b\u3082\u306e\u304c\u3042\u306a\u305f\u306e\u671f\u5f85\u306b\u5fdc\u3048\u308b\u3082\u306e\u3067\u3042\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u00a0<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"When_you_should_work_with_independent_medical_device_consultants\"><\/span><strong>\u72ec\u7acb\u3057\u305f\u533b\u7642\u6a5f\u5668\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8\u3068\u5354\u529b\u3059\u3079\u304d\u5834\u5408\u00a0<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">\u8981\u4ef6\u306b\u3088\u3063\u3066\u306f\u3001\u672c\u683c\u7684\u306aCRO\u3092\u96c7\u3046\u306e\u3067\u306f\u306a\u304f\u3001\u72ec\u7acb\u3057\u305f\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8\u3068\u4e00\u7dd2\u306b\u4ed5\u4e8b\u3092\u3059\u308b\u3053\u3068\u3092\u691c\u8a0e\u3057\u305f\u307b\u3046\u304c\u3044\u3044\u304b\u3082\u3057\u308c\u307e\u305b\u3093\u3002\u7814\u7a76\u306e\u975e\u5e38\u306b\u7279\u5b9a\u306e\u5074\u9762\u3067\u306e\u652f\u63f4\u3092\u6c42\u3081\u3066\u3044\u308b\u5834\u5408\uff1a\u4e00\u4eba\u3067\u306e\u4f5c\u696d\u3002\u4ee5\u4e0b\u306e\u3088\u3046\u306a\u81e8\u5e8a\u7814\u7a76\u306e\u8981\u7d20\u306b\u3064\u3044\u3066\u652f\u63f4\u304c\u5fc5\u8981\u306a\u5834\u5408\u304c\u3042\u308a\u307e\u3059\u3002 <\/span><span style=\"font-weight: 400;\"><br \/>\n<\/span><\/p>\n<ul>\n<li><span style=\"font-weight: 400;\">\u898f\u5236\u8981\u4ef6\u306e\u7406\u89e3\u3068\u00a0<\/span><a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/regulatory-writing\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDCRO\">\u898f\u5236\u6587\u66f8\u306e\u4f5c\u6210<\/a><\/li>\n<li><span style=\"font-weight: 400;\">\u81e8\u5e8a\u8a66\u9a13\u30d7\u30ed\u30c8\u30b3\u30eb\u306e\u4f5c\u6210\u00a0<\/span><\/li>\n<li><span style=\"font-weight: 400;\">\u3092\u6e96\u5099\u3057\u307e\u3059\u3002 <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/grant-writing\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDCRO\">\u52a9\u6210\u91d1\u7533\u8acb<\/a> \u307e\u305f\u306f\u7814\u7a76\u8a08\u753b\u66f8\u00a0<\/span><\/li>\n<li><span style=\"font-weight: 400;\">\u7d71\u8a08\u89e3\u6790\u3068\u7d50\u679c\u306e\u691c\u8a3c\u00a0<\/span><\/li>\n<li><span style=\"font-weight: 400;\">CER\uff08MDR\uff09\u306e\u81e8\u5e8a\u8a55\u4fa1\u00a0<\/span><\/li>\n<li><span style=\"font-weight: 400;\">FDA\u63d0\u51fa\u66f8\u985e\u00a0<\/span><\/li>\n<li><span style=\"font-weight: 400;\">\u6cbb\u9a13\u306b\u95a2\u3059\u308b\u30d7\u30ec\u30b9\u30ea\u30ea\u30fc\u30b9\u306e\u4f5c\u6210\u3084\u30b3\u30fc\u30dd\u30ec\u30fc\u30c8\u30b3\u30df\u30e5\u30cb\u30b1\u30fc\u30b7\u30e7\u30f3\u306e\u69cb\u7bc9\u00a0<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">\u30aa\u30f3\u30c7\u30de\u30f3\u30c9\u3067\u533b\u7642\u6a5f\u5668\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8\u3068\u4ed5\u4e8b\u3092\u3059\u308b\u3053\u3068\u3067\u3001\u304a\u5ba2\u69d8\u306f1\u5bfe1\u3067\u8981\u4ef6\u3092\u8aac\u660e\u3057\u3001\u6210\u679c\u7269\u3092\u30ab\u30b9\u30bf\u30de\u30a4\u30ba\u3059\u308b\u3053\u3068\u304c\u5bb9\u6613\u306b\u306a\u308a\u307e\u3059\u3002\u307e\u305f\u3001CRO\uff08\u533b\u85ac\u54c1\u958b\u767a\u696d\u52d9\u53d7\u8a17\u6a5f\u95a2\uff09\u3068\u306e\u9023\u643a\u306b\u4f34\u3046\u9593\u63a5\u8cbb\u3084\u7ba1\u7406\u8cbb\u3092\u7bc0\u7d04\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u533b\u7642\u6a5f\u5668\u306e\u8907\u96d1\u3055\u3068\u5fc5\u8981\u306a\u30b5\u30dd\u30fc\u30c8\u306e\u7a2e\u985e\u306b\u5fdc\u3058\u3066\u3001\u81ea\u4fe1\u3092\u6301\u3063\u3066\u533b\u7642\u6a5f\u5668\u3092\u767a\u58f2\u3067\u304d\u308b\u3088\u3046\u306b\u3001\u6700\u5927\u9650\u306e\u5229\u76ca\u3092\u5f97\u308b\u305f\u3081\u306e\u6700\u9069\u306a\u30a2\u30d7\u30ed\u30fc\u30c1\u3092\u9078\u629e\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002 <\/span><span style=\"font-weight: 400;\">\u00a0<\/span><\/p>\n<p><strong>\u3092\u76f8\u8ac7\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002 <a href=\"https:\/\/www.kolabtree.com\/industry\/medical-device\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDCRO\">\u533b\u7642\u6a5f\u5668\u30b9\u30da\u30b7\u30e3\u30ea\u30b9\u30c8<\/a>?Kolabtree\u3067\u5c02\u9580\u5bb6\u3068\u76f4\u63a5\u3064\u306a\u304c\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u3092\u6295\u7a3f\u3057\u3066\u898b\u7a4d\u3082\u308a\u3092\u3082\u3089\u3046\u306e\u306f\u7121\u6599\u3067\u3059\u3002 <a href=\"https:\/\/www.kolabtree.com\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDCRO\">\u4eca\u3059\u3050\u59cb\u3081\u308b<\/a><\/strong><\/p>","protected":false},"excerpt":{"rendered":"<p>Outsourcing clinical research to a medical device CRO can be a good decision for small medical device businesses. Here\u2019s what to look for while hiring a medical device CRO or medical device consultant.\u00a0 Small-to-medium-sized medical device companies often don\u2019t have the resources to be able to hire full-time teams who can handle all the complexities of clinical research for medical devices. Regulatory requirements, ethical considerations, routes to regulatory approval, technical documents: all of them form a crucial part of the clinical trial process. It is important that medical device companies choose a CRO that has had a good track record of success performing clinical trials and are up-to-date with the<\/p>\n<div class=\"read-more\"><a href=\"https:\/\/www.kolabtree.com\/blog\/ja\/what-to-look-for-in-a-medical-device-cro\/\" title=\"\u7d9a\u304d\u3092\u8aad\u3080\">\u7d9a\u304d\u3092\u8aad\u3080<\/a><\/div>","protected":false},"author":12,"featured_media":7729,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[443,540],"tags":[],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v20.1 (Yoast SEO v20.1) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>What to look for in a Medical Device CRO - The Kolabtree Blog<\/title>\n<meta name=\"description\" content=\"What to look for when hiring a medical device CRO, including advice from a clinical researcher. Also includes how to save time and costs.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/zh\/what-to-look-for-in-a-medical-device-cro\/\" \/>\n<meta property=\"og:locale\" content=\"ja_JP\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"What to look for in a Medical Device CRO\" \/>\n<meta property=\"og:description\" content=\"What to look for when hiring a medical device CRO, including advice from a clinical researcher. Also includes how to save time and costs.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.kolabtree.com\/blog\/ja\/zh\/what-to-look-for-in-a-medical-device-cro\/\" \/>\n<meta property=\"og:site_name\" content=\"The Kolabtree Blog\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/kolabtree\" \/>\n<meta property=\"article:published_time\" content=\"2020-06-01T13:57:17+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/06\/What-to-look-for-in-a-Medical-Device-CRO.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1050\" \/>\n\t<meta property=\"og:image:height\" content=\"700\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Ramya Sriram\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@kolabtree\" \/>\n<meta name=\"twitter:site\" content=\"@kolabtree\" \/>\n<meta name=\"twitter:label1\" content=\"\u57f7\u7b46\u8005\" \/>\n\t<meta name=\"twitter:data1\" content=\"Ramya Sriram\" \/>\n\t<meta name=\"twitter:label2\" content=\"\u63a8\u5b9a\u8aad\u307f\u53d6\u308a\u6642\u9593\" \/>\n\t<meta name=\"twitter:data2\" content=\"5\u5206\" \/>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"What to look for in a Medical Device CRO - The Kolabtree Blog","description":"What to look for when hiring a medical device CRO, including advice from a clinical researcher. 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