{"id":123,"date":"2024-05-24T13:32:08","date_gmt":"2024-05-24T05:32:08","guid":{"rendered":"http:\/\/localhost\/wordpress4\/?page_id=123"},"modified":"2025-06-19T14:10:31","modified_gmt":"2025-06-19T06:10:31","slug":"%e5%85%ac%e5%8f%b8%e7%b0%a1%e4%bb%8b","status":"publish","type":"page","link":"https:\/\/www.vcro.com.tw\/tw\/?page_id=123","title":{"rendered":"overview"},"content":{"rendered":"\n
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\u516c\u53f8\u7c21\u4ecb<\/h1>\n\n\n\n

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\u60a8\u81e8\u5e8a\u8a66\u9a57\u7684\u6700\u4f73\u5408\u4f5c\u5925\u4f34<\/p>\n\u7dad\u5dde\u751f\u7269\u79d1\u6280\u80a1\u4efd\u6709\u9650\u516c\u53f8 (VCRO<\/span>) \u5275\u7acb\u65bc1997\u5e747\u670821\u65e5\uff0c\u5df2\u5728\u5e02\u5834\u4e0a28\u5e74<\/cite><\/blockquote>\n\n\n\n

VCRO \u57281997\u5e74\u7531\u5275\u8fa6\u4eba\u674e\u7d14\u7d14\u535a\u58eb\u4e58\u8457\u5c0d\u65b0\u85e5\u958b\u767c\u7684\u71b1\u60c5\uff0c\u6295\u5165\u5c08\u696d Contract Clinical Research \u9818\u57df\uff0c\u674e\u535a\u58eb\u79c9\u8457 PK\/PD \u5c08\u9577\uff0c\u52a0\u4e0a\u7f8e\u570b\u65b0\u85e5 Phase I \u548c Astra Zeneca Phase III \u81e8\u5e8a\u7814\u7a76\u7d93\u9a57\uff0c\u5c07\u5176\u9577\u624d\u5c0e\u5165 VCRO \uff0c\u4ee5\u5275\u65b0\u7684\u670d\u52d9\u5167\u5bb9\u958b\u5275 VCRO \uff0c\u6210\u70ba\u53f0\u7063 CRO \u7684\u5148\u92d2\u3002<\/p>\n\n\n\n

VCRO \u7531\u91ab\u5b78\u5beb\u4f5c\u3001\u91ab\u85e5\u6cd5\u898f\u548c\u81e8\u5e8a\u71df\u904b\u8d77\u5bb6\uff0c\u65bc2\u5e74\u5167\u6574\u4f75\u751f\u7269\u7d71\u8a08\u5206\u6790\u6210\u70ba\u5168\u65b9\u4f4d\u81e8\u5e8a\u6848\u4ef6\u670d\u52d9\u80fd\u529b\u3002 VCRO \u5728\u63a5\u7e8c10\u5e74\u4e2d\u7a4d\u6975\u64f4\u5f35\uff0c\u5f9e\u8de8\u5165 GLP PK \u751f\u7269\u5206\u6790\u9818\u57df\uff0c\u5230\u7387\u5148\u5275\u5efa E \u5316\u81e8\u5e8a\u8a66\u9a57\u7cfb\u7d71\uff1b\u540c\u6642\u8d77\u52d5\u591a\u570b\u8a66\u9a57\u7ba1\u7406\u8207\u64cd\u4f5c\uff0c\u529b\u6c42\u5b8c\u5099\u81e8\u5e8a\u7814\u7a76\u93c8\u4e26\u8207\u570b\u969b\u63a5\u8ecc\u3002\u57282009\u5e74 VCRO \u6210\u529f\u7684\u5c07\u53f0\u7063\u9996\u4f8b\u5168\u7403\u65b0\u85e5\u9001\u5165 US FDA IND \uff0c\u63a8\u52d5\u958b\u555f\u4e86\u7f8e\u53f0\u96d9\u5831\u65b0\u85e5\u958b\u767c\u7684\u84ec\u52c3\u767c\u5c55\u3002\u76ee\u524d\u7d2f\u7a4d\u63a8\u9032\u903e50 \u4ef6 US FDA IND \u7533\u8acb\uff0c\u5ee3\u53ca\u5404\u5275\u65b0\u9818\u57df\uff0c\u5982 gene therapy\u3001Live Biotherapeutic Product (LBP)\u3001drug-device combinational therapy\u3001cell therapy\u3001siRNA drugs\u3001miRNA drugs\u3001nucleotide drugs\u3001AAV\u3001botanical\u3001505b2 \u7b49\u7686\u70ba VCRO \u6210\u529f\u6848\u4f8b\u3002<\/p>\n\n\n\n

VCRO \u5c62\u5c62\u7de0\u9020\u8207\u65b0\u5275\u751f\u6280\u88fd\u85e5\u5ba2\u6236\u5408\u4f5c\u6210\u529f\u7684\u5be6\u7e3e\uff0c\u518d\u518d\u5730\u70ba\u5ba2\u6236\u7684\u62db\u5546\u8207\u52df\u8cc7\u52a0\u503c\uff0c\u4e26\u52a9\u653b\u4e0a\u6ac3\u4e0a\u5e02\u7684\u91cd\u8981\u91cc\u7a0b\u7891\u3002\u5ba2\u6236\u4e5f\u56e0\u6b64\u8207 VCRO \u7de0\u7d50\u6210\u70ba IND\u3001Phase I\u3001Phase II\u3001Phase III\u3001NDA (BLA) \u7684\u5fe0\u5be6\u5925\u4f34\u95dc\u4fc2\u3002 VCRO \u591a\u5e74\u7d2f\u7a4d\u5c08\u696d\u8207\u7d93\u9a57\u7684\u80fd\u91cf\uff0c\u4e5f\u5728\u6d77\u5916\u62d3\u5c55\u64da\u9ede\uff1a2020\u5e74\u6210\u7acb\u65bc\u4e2d\u570b\u7684\u4e0a\u6d77\u7dad\u5dde\u91ab\u85e5\u79d1\u6280\u30012022\u5e74\u65bc\u7f8e\u570b\u6210\u7acb\u7684 Virginia Contract Research Organization Inc. \u3002\u5c07 VCRO \u89f8\u89d2\u64f4\u53ca\u570b\u969b\u6230\u7565\u4f4d\u7f6e\u3002<\/p>\n\n\n\n

VCRO<\/span> \u4ee5 Vibrance, Commitment, Resilience \u4ee5\u53ca Open-minded \u81ea\u8a31\u3002<\/p><\/blockquote><\/figure>\n\n\n\n

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\u5728\u53f0\u7063\uff0cVCRO<\/span>\u662f\u6700\u5bcc\u7d93\u9a57\u548c\u6b77\u53f2\u60a0\u4e45\u7684\u7814\u7a76\u53d7\u8a17\u7d44\u7e54 (CRO)\uff0c\u5c08\u9580\u63d0\u4f9b\u5404\u9805\u81e8\u5e8a\u670d\u52d9\u3002\u6211\u5011\u9075\u5b88\u570b\u969b\u91ab\u85e5\u6cd5\u898f\u5354\u5408\u6703 (ICH) \u6240\u5236\u5b9a\u7684\u6a19\u6e96\u57f7\u884c\u81e8\u5e8a\u8a66\u9a57\u3002<\/p>\n\n\n\n

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\u91ab\u5b78\u9818\u57df<\/h3>\n<\/div>\n\n\n\n
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VCRO<\/span> \u81ea1997\u5e74\u4f86\uff0c\u53c3\u8207\u5404\u4e0d\u540c\u91ab\u5b78\u9818\u57df\u7684\u81e8\u5e8a\u7814\u7a76\uff0c\u4ee5\u5be6\u8cea\u6210\u7e3e\uff0c\u6210\u70ba\u60a8\u5728\u81e8\u5e8a\u7814\u7a76\u4e2d\u7684\u6700\u4f73\u5408\u4f5c\u5925\u4f34\u3002\u4f8b\u5982: \u816b\u7624\u79d1\u3001\u514d\u75ab\u79d1\u3001\u611f\u67d3\u79d1\u548c\u7d30\u80de\u7642\u6cd5……\u7b49\u3002<\/p>\n\n\n\n

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VCRO<\/span> \u64c1\u6709\u4e8c\u5341\u5e74\u4ee5\u4e0a\u57f7\u884c\u7b26\u5408 ICH GCP \u898f\u7bc4\u81e8\u5e8a\u8a66\u9a57\u4e4b\u7d93\u9a57\uff0c\u542b\u62ec\u65b0\u85e5\u81e8\u5e8a\u958b\u767c\u968e\u6bb5 (Phase I, II, III) \u5230\u85e5\u54c1\u4e0a\u5e02\u5f8c\u7684 Phase IV \u8a66\u9a57\u3002<\/p>\n\n\n\n

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US FDA IND<\/h3>\n<\/div>\n\n\n\n
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VCRO<\/span> \u65bc\u91ab\u5b78\u6587\u737b\u5beb\u4f5c\u7684\u670d\u52d9\u5df2\u6709US FDA IND \u6709\u95dc\u64b0\u5beb\u53ca\u63d0\u4ea4\u9001\u4ef6\u7684\u9023\u7e8c\u6210\u529f\u7d93\u9a57\u3002\u8fd1\u5e74\u4f86\uff0c\u95dc\u65bc US FDA IND \u7814\u7a76\uff0c\u6211\u5011\u5df2\u5f9e\u53c3\u8207\u8005\u8f49\u8b8a\u70ba\u9818\u5c0e\u8005\u7684\u89d2\u8272\u3002<\/p>\n\n\n\n

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GCP Inspection<\/strong><\/h3>\n<\/div>\n\n\n\n
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VCRO<\/span> \u59cb\u7d42\u5805\u6301\u63d0\u4f9b\u7b26\u5408\u570b\u969b\u81e8\u5e8a\u8a66\u9a57\u57f7\u884c\u7684\u5c08\u696d\u54c1\u8cea\u6a19\u6e96\u66ff\u5ba2\u6236\u670d\u52d9\u3002\u7dad\u5dde\u7d2f\u7a4d\u591a\u5e74\u7684\u7d93\u9a57\u8207\u5be6\u7e3e\uff0c\u81f3\u4eca\u5df2\u6b77\u7d93\u8fd1\u767e\u4ef6\u81e8\u5e8a\u7814\u7a76\u67e5\u6838\uff0c\u4e26\u64c1\u6709100% GCP\u67e5\u6838\u901a\u904e\u7d00\u9304\u3002<\/p>\n\n\n\n

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<\/p>\n","protected":false},"excerpt":{"rendered":"

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