{"id":8345,"date":"2025-06-05T11:34:42","date_gmt":"2025-06-05T03:34:42","guid":{"rendered":"https:\/\/regask.com\/?p=8345"},"modified":"2025-07-17T10:53:12","modified_gmt":"2025-07-17T02:53:12","slug":"%e7%b0%a1%e7%b4%a0%e5%8c%96%e3%81%95%e3%82%8c%e3%80%81%e3%82%b3%e3%83%b3%e3%83%97%e3%83%a9%e3%82%a4%e3%82%a2%e3%83%b3%e3%82%b9%e3%81%ab%e6%ba%96%e6%8b%a0%e3%81%97%e3%80%81%e6%8b%a1%e5%bc%b5%e5%8f%af","status":"publish","type":"post","link":"https:\/\/regask.com\/ja\/powering-global-hybrid-trials-simplified-compliant-and-scalable\/","title":{"rendered":"\u30b0\u30ed\u30fc\u30d0\u30eb\u306a\u30cf\u30a4\u30d6\u30ea\u30c3\u30c9\u81e8\u5e8a\u8a66\u9a13\u306e\u63a8\u9032\uff1a\u7c21\u7d20\u5316\u3001\u52b9\u7387\u5316\u3001\u305d\u3057\u3066\u81ea\u52d5\u5316\u2026"},"content":{"rendered":"<h4><strong>\u8ab2\u984c<\/strong><\/h4>\n<p class=\"p1\">\u3042\u308b\u5927\u624b\u30b0\u30ed\u30fc\u30d0\u30eb\u88fd\u85ac\u4f1a\u793e\u306f\u3001\u81ea\u793e\u306e\u7279\u6b8a\u533b\u7642\u76ee\u7684\u98df\u54c1\uff08FSMP\uff09\u88fd\u54c1\u306e\u30cf\u30a4\u30d6\u30ea\u30c3\u30c9\u81e8\u5e8a\u8a66\u9a13\u306e\u898f\u6a21\u62e1\u5927\u3092\u6e96\u5099\u3057\u3066\u3044\u307e\u3057\u305f\u3002\u3057\u304b\u3057\u3001\u5730\u57df\u3054\u3068\u306b\u898f\u5236\u304c\u7570\u306a\u308a\u3001\u305d\u306e\u5909\u5316\u304c\u6fc0\u3057\u3044\u3053\u3068\u304c\u3001\u8a66\u9a13\u306e\u52b9\u679c\u7684\u306a\u898f\u6a21\u62e1\u5927\u306b\u5927\u304d\u306a\u969c\u5bb3\u3068\u306a\u3063\u3066\u3044\u307e\u3057\u305f\u3002<\/p>\n<p class=\"p1\">\u30cf\u30a4\u30d6\u30ea\u30c3\u30c9\u304a\u3088\u3073\u5206\u6563\u578b\u81e8\u5e8a\u8a66\u9a13 (DCT) \u306e\u898f\u5236\u67a0\u7d44\u307f\u306f\u4e16\u754c\u4e2d\u3067\u5927\u304d\u304f\u7570\u306a\u308a\u3001\u7d71\u4e00\u3055\u308c\u305f\u30d7\u30ec\u30a4\u30d6\u30c3\u30af\u306f\u5b58\u5728\u3057\u307e\u305b\u3093\u3002<\/p>\n<p class=\"p1\">\u96fb\u5b50\u540c\u610f\u3001\u30c7\u30b8\u30bf\u30eb\u30d8\u30eb\u30b9\u30c4\u30fc\u30eb\u3001\u5728\u5b85\u533b\u7642\u5c02\u9580\u5bb6\uff08HHCP\uff09\u306b\u3088\u308b\u8a2a\u554f\u3001\u9060\u9694\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u3001\u30c7\u30fc\u30bf\u30d7\u30e9\u30a4\u30d0\u30b7\u30fc\u306b\u95a2\u3059\u308b\u8981\u4ef6\u306f\u3001\u7ba1\u8f44\u533a\u57df\u306b\u3088\u3063\u3066\u5927\u304d\u304f\u7570\u306a\u308a\u307e\u3059\u3002\u8ab2\u984c\u306f\u3001\u8a66\u9a13\u3092\u3069\u306e\u3088\u3046\u306b\u5b9f\u65bd\u3059\u308b\u304b\u3060\u3051\u3067\u306a\u304f\u3001\u5404\u56fd\u3067\u9069\u7528\u3055\u308c\u308b\u898f\u5236\u3092\u7406\u89e3\u3059\u308b\u3053\u3068\u3067\u3042\u308a\u3001\u73fe\u5730\u3067\u306e\u5b9f\u65bd\u3092\u5c0e\u304f\u305f\u3081\u306e\u30ab\u30b9\u30bf\u30de\u30a4\u30ba\u3055\u308c\u305f\u898f\u5236\u30d7\u30ec\u30a4\u30d6\u30c3\u30af\u306e\u5fc5\u8981\u6027\u304c\u6d6e\u304d\u5f6b\u308a\u306b\u306a\u308a\u307e\u3057\u305f\u3002<\/p>\n<h4 data-start=\"781\" data-end=\"933\"><\/h4>\n<h4 data-start=\"781\" data-end=\"933\"><strong data-start=\"781\" data-end=\"804\">RegASK\u30a2\u30d7\u30ed\u30fc\u30c1<\/strong><\/h4>\n<p><span data-teams=\"true\">RegASK\u306f\u3001 <a href=\"https:\/\/regask.com\/ja\/%e8%a3%bd%e5%93%81\/#RegGenius:~:text=Book%20a%20demo-,RegGenius,-Your%20GenAI%20co\">AI\u99c6\u52d5\u578b\u898f\u5236\u60c5\u5831\u30bd\u30ea\u30e5\u30fc\u30b7\u30e7\u30f3<\/a> \u6df1\u3044\u5c02\u9580\u77e5\u8b58\u306b\u3088\u308a\u3001\u8907\u96d1\u306a\u554f\u984c\u306b\u69cb\u9020\u304c\u3082\u305f\u3089\u3055\u308c\u307e\u3057\u305f\u3002<\/span><\/p>\n<p>\u79c1\u305f\u3061\u306f\u3001 <strong>DCT\u898f\u5236\u30ac\u30a4\u30c9\u30d6\u30c3\u30af<\/strong> 27\u306e\u6226\u7565\u7684\u5e02\u5834\u5411\u3051\u3002\u5404\u30ac\u30a4\u30c9\u30d6\u30c3\u30af\u306b\u306f\u4ee5\u4e0b\u304c\u542b\u307e\u308c\u3066\u3044\u307e\u3057\u305f\u3002<\/p>\n<ul>\n<li>\u5730\u57df\u306eDCT\u898f\u5236\u306b\u95a2\u3059\u308b\u660e\u78ba\u3067\u691c\u8a3c\u3055\u308c\u305f\u5b9f\u7528\u7684\u306a\u6d1e\u5bdf<\/li>\n<li>\u898f\u5236\u8981\u4ef6\u3068\u6e96\u5099\u72b6\u6cc1\u3092\u8a55\u4fa1\u3059\u308b\u305f\u3081\u5404\u56fd\u3092\u4e26\u3079\u3066\u6bd4\u8f03\u3059\u308b<\/li>\n<li>\u81e8\u5e8a\u30aa\u30da\u30ec\u30fc\u30b7\u30e7\u30f3\u3068\u898f\u5236\u30c1\u30fc\u30e0\u3092\u30b5\u30dd\u30fc\u30c8\u3059\u308b\u5b9f\u7528\u7684\u306aQ&amp;A\u30ca\u30d3\u30b2\u30fc\u30b7\u30e7\u30f3<\/li>\n<li>\u898f\u5236\u74b0\u5883\u306e\u5909\u5316\u306b\u5408\u308f\u305b\u3066\u30c1\u30fc\u30e0\u3092\u8abf\u6574\u3059\u308b\u305f\u3081\u306e\u7d99\u7d9a\u7684\u306a\u66f4\u65b0<\/li>\n<\/ul>\n\t<div id=\"gap-1593604223\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1593604223 {\n  padding-top: 30px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4><strong>\u4e3b\u306a\u30cf\u30a4\u30e9\u30a4\u30c8<\/strong><\/h4>\n\t<div id=\"gap-1737856138\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1737856138 {\n  padding-top: 30px;\n}\n<\/style>\n\t<\/div>\n\t\n\t<div id=\"stack-745159128\" class=\"stack stack-row justify-start items-stretch\">\n\t\t\n<div class=\"row equal-height-row\"  id=\"row-517569809\">\n\n\t<div id=\"col-1984898436\" class=\"col medium-4 small-12 large-4\"  >\n\t\t\t\t<div class=\"col-inner text-left dark\" style=\"background-color:rgb(10, 35, 66);\" >\n\t\t\t\n\t\t\t\n<h1>27<\/h1>\n<p>\u5bfe\u8c61\u3068\u306a\u308b\u7ba1\u8f44\u533a\u57df<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1984898436 > .col-inner {\n  padding: 10% 10% 10% 10%;\n  border-radius: 16px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1642179655\" class=\"col medium-4 small-12 large-4\"  >\n\t\t\t\t<div class=\"col-inner\" style=\"background-color:#e5e8fb;\" >\n\t\t\t\n\t\t\t\n<h1>90%<\/h1>\n<p>\u56fd\u306e\u898f\u5236\u3092\u307e\u3068\u3081\u308b\u306e\u306b\u304b\u304b\u308b\u6642\u9593\u3092\u7bc0\u7d04<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1642179655 > .col-inner {\n  padding: 10% 10% 10% 10%;\n  border-radius: 16px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-647010306\" class=\"col medium-4 small-12 large-4\"  >\n\t\t\t\t<div class=\"col-inner dark\" style=\"background-color:#0a2342;\" >\n\t\t\t\n\t\t\t\n<h1>\u5bb9\u6613\u306b<\/h1>\n<p>\u30c7\u30fc\u30bf\u306b\u30a2\u30af\u30bb\u30b9\u3059\u308b<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-647010306 > .col-inner {\n  padding: 10% 10% 10% 10%;\n  border-radius: 16px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n<style>\n#row-517569809 > .col > .col-inner {\n  background-color: #0a2342;\n  border-radius: 14px;\n}\n<\/style>\n<\/div>\n\t\t\n<style>\n#stack-745159128 > * {\n  --stack-gap: 0rem;\n}\n<\/style>\n\t<\/div>\n\t\n<a href=\"https:\/\/regask.com\/ja\/%e6%8e%a5%e8%a7%a6\/\" class=\"button primary\" >\n\t\t<span>RegASK\u30a2\u30d7\u30ed\u30fc\u30c1\u306e\u8a73\u7d30\u306b\u3064\u3044\u3066\u306f\u3001\u5f53\u793e\u306e\u30c1\u30fc\u30e0\u306b\u304a\u554f\u3044\u5408\u308f\u305b\u304f\u3060\u3055\u3044\u3002<\/span>\n\t<\/a>\n\n\t<div id=\"gap-1795489396\" class=\"gap-element clearfix\" style=\"display:block; 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height:auto;\">\n\t\t\n<style>\n#gap-545189099 {\n  padding-top: 30px;\n}\n<\/style>\n\t<\/div>\n\t\n<div class=\"is-divider divider clearfix\" style=\"max-width:100%;height:2px;background-color:rgb(197, 202, 236);\"><\/div>\n\t<div id=\"gap-1125054917\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1125054917 {\n  padding-top: 30px;\n}\n<\/style>\n\t<\/div>\n\t\n<h2>\u3088\u304f\u3042\u308b\u8cea\u554f<\/h2>\n\t<div id=\"gap-411982573\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-411982573 {\n  padding-top: 30px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4><strong>Q1: RegASK \u306f\u3069\u306e\u3088\u3046\u306b\u3057\u3066\u56fd\u3092\u307e\u305f\u304c\u308b DCT \u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306e\u7c21\u7d20\u5316\u306b\u5f79\u7acb\u3061\u307e\u3059\u304b?<\/strong><\/h4>\n<p>RegASK\u306f\u3001\u5404\u56fd\u56fa\u6709\u306e\u898f\u5236\u8981\u4ef6\u306b\u95a2\u3059\u308b\u660e\u78ba\u304b\u3064\u691c\u8a3c\u6e08\u307f\u306e\u77e5\u898b\u3092\u63d0\u4f9b\u3059\u308b\u3053\u3068\u3067\u3001\u81e8\u5e8a\u8a66\u9a13\u306e\u5b9f\u65bd\u306b\u304a\u3051\u308b\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3092\u7c21\u7d20\u5316\u3057\u307e\u3059\u3002\u5c02\u9580\u5bb6\u304c\u57f7\u7b46\u3057\u305f\u30ac\u30a4\u30c9\u30d6\u30c3\u30af\u3068\u30b0\u30ed\u30fc\u30d0\u30eb\u30a4\u30f3\u30c6\u30ea\u30b8\u30a7\u30f3\u30b9\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0\u306f\u3001eConsent\u3001\u9060\u9694\u533b\u7642\u3001\u30ea\u30e2\u30fc\u30c8\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u3068\u3044\u3063\u305f\u5206\u6563\u578b\u30b3\u30f3\u30dd\u30fc\u30cd\u30f3\u30c8\u306b\u95a2\u3059\u308b\u5404\u56fd\u306e\u30eb\u30fc\u30eb\u3092\u95a2\u4fc2\u8005\u304c\u7406\u89e3\u3067\u304d\u308b\u3088\u3046\u652f\u63f4\u3057\u3001\u591a\u69d8\u306a\u898f\u5236\u74b0\u5883\u306b\u304a\u3044\u3066\u4e00\u8cab\u6027\u3068\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u9075\u5b88\u3092\u78ba\u4fdd\u3057\u305f\u8a66\u9a13\u6226\u7565\u3092\u5b9f\u73fe\u3057\u307e\u3059\u3002<\/p>\n<h4><\/h4>\n<h4><strong>\u8cea\u554f2: <span data-teams=\"true\">\u898f\u5236\u30ac\u30a4\u30c9\u30d6\u30c3\u30af\u306b\u306f\u3069\u306e\u3088\u3046\u306a\u5185\u5bb9\u304c\u542b\u307e\u308c\u3066\u3044\u307e\u3059\u304b?<\/span><\/strong><\/h4>\n<p>RegASK\u306e\u898f\u5236\u30ac\u30a4\u30c9\u30d6\u30c3\u30af\u306f\u3001\u502b\u7406\u59d4\u54e1\u4f1a\u306e\u30d7\u30ed\u30bb\u30b9\u3001\u30bf\u30a4\u30e0\u30e9\u30a4\u30f3\u3001\u96fb\u5b50\u540c\u610f\u3001\u96fb\u5b50\u7f72\u540d\u3001\u30c7\u30fc\u30bf\u51e6\u7406\u3068\u3044\u3063\u305f\u5206\u6563\u5316\u3055\u308c\u305f\u8981\u7d20\u3092\u7db2\u7f85\u3057\u3001\u81e8\u5e8a\u8a66\u9a13\u3092\u53d6\u308a\u5dfb\u304f\u72b6\u6cc1\u306b\u3064\u3044\u3066\u5404\u56fd\u56fa\u6709\u306e\u6d1e\u5bdf\u3092\u63d0\u4f9b\u3057\u307e\u3059\u3002\u5bfe\u8c61\u5e02\u5834\u306b\u304a\u3051\u308b\u8a66\u9a13\u306e\u52b9\u679c\u7684\u306a\u8a08\u753b\u3068\u898f\u5236\u9075\u5b88\u3092\u652f\u63f4\u3057\u307e\u3059\u3002<\/p>\n<h4><\/h4>\n<h4><strong>Q3: RegASK \u306f\u6025\u901f\u306b\u5909\u5316\u3059\u308b\u898f\u5236\u306b\u3069\u306e\u3088\u3046\u306b\u5bfe\u5fdc\u3057\u3066\u3044\u307e\u3059\u304b?<\/strong><\/h4>\n<p>RegASK \u306f\u3001\u4ee5\u4e0b\u306e\u7d44\u307f\u5408\u308f\u305b\u306b\u3088\u308a\u3001\u6025\u901f\u306b\u5909\u5316\u3059\u308b\u898f\u5236\u306b\u5148\u3093\u3058\u3066\u5bfe\u5fdc\u3057\u307e\u3059\u3002<\/p>\n<p>\u2022 \u9ad8\u5ea6\u306aAI\u99c6\u52d5\u578b\u76e3\u8996\u30c4\u30fc\u30eb<br \/>\n\u2022 \u898f\u5236\u5c02\u9580\u5bb6\u306e\u4e16\u754c\u7684\u306a\u30cd\u30c3\u30c8\u30ef\u30fc\u30af<br \/>\n\u2022 \u516c\u5f0f\u30a2\u30c3\u30d7\u30c7\u30fc\u30c8\u3068\u696d\u754c\u52d5\u5411\u306e\u7d99\u7d9a\u7684\u306a\u5206\u6790<\/p>\n<p>\u3053\u308c\u306b\u3088\u308a\u3001\u307b\u307c\u30ea\u30a2\u30eb\u30bf\u30a4\u30e0\u3067\u691c\u8a3c\u6e08\u307f\u306e\u6d1e\u5bdf\u3092\u63d0\u4f9b\u3067\u304d\u308b\u3088\u3046\u306b\u306a\u308a\u3001\u30af\u30e9\u30a4\u30a2\u30f3\u30c8\u304c\u8fc5\u901f\u306b\u9069\u5fdc\u3057\u3001\u5e02\u5834\u5168\u4f53\u3067\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3092\u7dad\u6301\u3067\u304d\u308b\u3088\u3046\u306b\u306a\u308a\u307e\u3059\u3002<\/p>","protected":false},"excerpt":{"rendered":"<p>The Challenge A leading global pharmaceutical company was preparing to scale hybrid clinical trials for its Food for Special Medical Purposes (FSMP) product. However, the diverse and evolving regional regulations posed a major hurdle to scaling the trials effectively. Regulatory frameworks for hybrid and decentralized clinical trials (DCTs) vary significantly across the globe, and no harmonized playbook exists. The requirements for eConsent, digital health tools, home healthcare professional (HHCP) visits, remote monitoring, and data privacy differ substantially by jurisdiction. The challenge was not just how to execute the trials, but understanding which regulations applied in each country, highlighting the need for tailored regulatory playbooks to guide local implementation. The RegASK&#8230;<\/p>","protected":false},"author":43,"featured_media":8358,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[17,527,18,21],"tags":[197],"class_list":["post-8345","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-case-study","category-united-states-regulations","category-food-and-beverage","category-pharma-and-biotech","tag-infant-formula"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.6 (Yoast SEO v27.6) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>US | Decentralized Clinical Trials for FSMP | Case Study | RegASK<\/title>\n<meta name=\"description\" content=\"Learn how RegASK enabled global hybrid clinical trials with tailored regulatory intelligence\u2014simplifying compliance and accelerating trial execution.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/regask.com\/ja\/\u7c21\u7d20\u5316\u3055\u308c\u3001\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306b\u6e96\u62e0\u3057\u3001\u62e1\u5f35\u53ef\/\" \/>\n<meta property=\"og:locale\" content=\"ja_JP\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Powering Global Hybrid Clinical Trials: Simplified, Compliant, and Scalable\" \/>\n<meta property=\"og:description\" content=\"Learn how RegASK enabled global hybrid clinical trials with tailored regulatory intelligence\u2014simplifying compliance and accelerating trial execution.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/regask.com\/ja\/\u7c21\u7d20\u5316\u3055\u308c\u3001\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306b\u6e96\u62e0\u3057\u3001\u62e1\u5f35\u53ef\/\" \/>\n<meta property=\"og:site_name\" content=\"RegASK\" \/>\n<meta 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