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_builder_version=&#8221;4.5.3&#8243; text_font=&#8221;||||||||&#8221; text_font_size=&#8221;16px&#8221; header_font=&#8221;||||||||&#8221; header_3_font=&#8221;||||||||&#8221; header_3_text_color=&#8221;#ffffff&#8221; hover_enabled=&#8221;0&#8243; header_2_text_align=&#8221;center&#8221;]<\/p>\n<h2>\u4e13\u4e1a\u7684\u533b\u7597\u6587\u4ef6\u7ffb\u8bd1<\/h2>\n<p>\u533b\u7597\u6587\u4ef6\u7684\u8303\u56f4\u975e\u5e38\u5e7f\uff0c\u5305\u62ec\u60a3\u8005\u4fe1\u606f\u8868\u3001\u533b\u836f\u8425\u9500\u6750\u6599\u3001\u4e34\u5e8a\u670d\u52a1\u534f\u8bae\u548c\u901a\u7528\u6280\u672f\u6587\u4ef6(CTD)\u7b49\u3002 \u751f\u547d\u79d1\u5b66\u884c\u4e1a\u662f\u4e00\u4e2a\u77e5\u8bc6\u578b\u884c\u4e1a\uff0c\u6709\u5f88\u591a\u7f29\u7565\u8bed\u548c\u6280\u672f\u672f\u8bed\u3002\u5bf9\u4e8e\u62d3\u5c55\u6d77\u5916\u5e02\u573a\u7684\u751f\u547d\u79d1\u5b66\u516c\u53f8\u6765\u8bf4\uff0c\u51c6\u786e\u7684\u533b\u7597\u6587\u4ef6\u7ffb\u8bd1\u662f\u83b7\u5f97\u5e02\u573a\u51c6\u5165\u548c\u9075\u5b88\u5f53\u5730\u6cd5\u89c4\u8981\u6c42\u7684\u5173\u952e\u3002<\/p>\n<p>\u65e0\u8bba\u60a8\u662f\u533b\u7597\u8bbe\u5907\u5236\u9020\u5546\u3001\u533b\u836f\u96f6\u552e\u5546\u3001\u533b\u7597\u7ecf\u9500\u5546\uff0c\u8fd8\u662f\u4ece\u4e8b\u751f\u7269\u533b\u5b66\u5de5\u7a0b\u7684\u4f01\u4e1a\uff0cCSOFT\u534e\u4e5f\u751f\u547d\u79d1\u5b66\u62e5\u6709\u4e30\u5bcc\u7684\u7ecf\u9a8c\u548c\u8d44\u6e90\uff0c\u53ef\u4ee5\u4e3a\u6240\u6709\u7c7b\u578b\u7684\u533b\u7597\u6587\u4ef6\u63d0\u4f9b\u975e\u5e38\u7cbe\u51c6\u7684\u7ffb\u8bd1\u89e3\u51b3\u65b9\u6848\uff0c\u5305\u62ec\uff1a<br \/>\n[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=&#8221;1_2,1_2&#8243; _builder_version=&#8221;3.25&#8243; custom_padding=&#8221;||0px&#8221;][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;3.25&#8243; custom_padding=&#8221;|||&#8221; custom_padding__hover=&#8221;|||&#8221;][et_pb_text disabled_on=&#8221;on|on|off&#8221; _builder_version=&#8221;4.5.3&#8243; text_font=&#8221;||||||||&#8221; text_font_size=&#8221;16px&#8221; hover_enabled=&#8221;0&#8243;]<\/p>\n<ul>\n<li><a href=\"https:\/\/lifesciences.csoftintl.com\/zh-hans\/presentacion-ctd-ectd\/\"><u>CTD\/eCTD \u63d0\u4ea4<\/u><\/a><\/li>\n<li><a href=\"https:\/\/lifesciences.csoftintl.com\/zh-hans\/%e4%b8%b4%e5%ba%8a%e8%af%95%e9%aa%8c%e7%bf%bb%e8%af%91\/\"><u>0\u81f3IV\u671f\u4e34\u5e8a\u8bd5\u9a8c\u6587\u4ef6<\/u><\/a><\/li>\n<li><a href=\"https:\/\/lifesciences.csoftintl.com\/zh-hans\/%e6%af%92%e7%90%86%e5%ad%a6%e7%bf%bb%e8%af%91\/\"><u>\u6bd2\u7406\u5b66\u62a5\u544a<\/u><\/a><\/li>\n<li>\u7814\u7a76\u534f\u8bae<\/li>\n<li>\u7535\u5b50\u5065\u5eb7\u6863\u6848\uff08EHR)<\/li>\n<li>\u53d1\u5c55\u5b89\u5168\u66f4\u65b0\u62a5\u544a (DSUR)<\/li>\n<li><a href=\"https:\/\/lifesciences.csoftintl.com\/zh-hans\/%e4%b8%b4%e5%ba%8a%e7%bb%93%e6%9e%9c%e8%af%84%e4%bc%b0%e7%bf%bb%e8%af%91\/\"><u>\u4e34\u5e8a\u7ed3\u679c\u8bc4\u4f30 (COA)<\/u><\/a><\/li>\n<li><a href=\"https:\/\/lifesciences.csoftintl.com\/zh-hans\/%e7%9f%a5%e6%83%85%e5%90%8c%e6%84%8f%e4%b9%a6%e7%bf%bb%e8%af%91\/\"><u>\u77e5\u60c5\u540c\u610f\u4e66<\/u><\/a><\/li>\n<li>\u6848\u4f8b\u62a5\u544a\u8868 (CRF)<\/li>\n<li><a href=\"https:\/\/lifesciences.csoftintl.com\/zh-hans\/%e5%8c%96%e5%ad%a6%e5%8d%b1%e5%ae%b3%e8%af%84%e4%bc%b0%e7%bf%bb%e8%af%91\/\"><u>\u5316\u5b66\u54c1\u5371\u5bb3\u8bc4\u4f30 (CHA)<\/u><\/a><\/li>\n<li><a href=\"https:\/\/lifesciences.csoftintl.com\/zh-hans\/%e5%8c%96%e5%ad%a6%e5%ae%89%e5%85%a8%e6%8a%a5%e5%91%8a%e7%bf%bb%e8%af%91\/\"><u>\u5316\u5b66\u5b89\u5168\u62a5\u544a (CSR)<\/u><\/a><\/li>\n<li><a href=\"https:\/\/lifesciences.csoftintl.com\/zh-hans\/%e4%b8%b4%e5%ba%8a%e7%a0%94%e7%a9%b6\/\"><u>\u4e34\u5e8a\u7814\u7a76\u62a5\u544a (CSR)<\/u><\/a><\/li>\n<\/ul>\n<p>[\/et_pb_text][\/et_pb_column][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;3.25&#8243; custom_padding=&#8221;|||&#8221; custom_padding__hover=&#8221;|||&#8221;][et_pb_text disabled_on=&#8221;on|on|off&#8221; _builder_version=&#8221;4.5.3&#8243; text_font=&#8221;||||||||&#8221; text_font_size=&#8221;16px&#8221; hover_enabled=&#8221;0&#8243;]<\/p>\n<ul>\n<li><a href=\"https:\/\/lifesciences.csoftintl.com\/zh-hans\/%e7%94%9f%e5%91%bd%e7%a7%91%e5%ad%a6%e6%b3%95%e5%be%8b%e7%bf%bb%e8%af%91\/\"><u>\u4e34\u5e8a\u670d\u52a1\u534f\u8bae<\/u><\/a><\/li>\n<li><a href=\"https:\/\/lifesciences.csoftintl.com\/zh-hans\/ifu%e7%bf%bb%e8%af%91\/\"><u>\u4f7f\u7528\u8bf4\u660e\u4e66 (IFU)<\/u><\/a><\/li>\n<li><a href=\"https:\/\/lifesciences.csoftintl.com\/zh-hans\/patient-recruitment\/\"><u>\u60a3\u8005\u62db\u52df\u6750\u6599<\/u><\/a><\/li>\n<li>FDA, EMA, and\u00a0<a href=\"https:\/\/lifesciences.csoftintl.com\/zh-hans\/%e4%ba%9a%e6%b4%b2%e6%b3%a8%e5%86%8c%e6%9c%8d%e5%8a%a1\/%e4%ba%9a%e6%b4%b2%e5%b8%82%e5%9c%ba%e5%87%86%e5%85%a5\/\"><u>NMPA \u63d0\u4ea4<\/u><\/a><\/li>\n<li><a href=\"https:\/\/lifesciences.csoftintl.com\/zh-hans\/%e6%82%a3%e8%80%85%e4%bf%a1%e6%81%af%e8%a1%a8%e7%bf%bb%e8%af%91\/\"><u>\u60a3\u8005\u4fe1\u606f\u8868<\/u><\/a><\/li>\n<li><a href=\"https:\/\/lifesciences.csoftintl.com\/zh-hans\/%e5%9b%bd%e9%99%85%e4%b8%93%e5%88%a9%e7%bf%bb%e8%af%91\/\"><u>\u4e13\u5229<\/u><\/a><\/li>\n<li><a href=\"https:\/\/lifesciences.csoftintl.com\/zh-hans\/%e7%a7%91%e5%ad%a6%e6%96%87%e7%8c%ae%e7%bf%bb%e8%af%91\/\"><u>\u5b66\u672f\u8bba\u6587<\/u><\/a><\/li>\n<li>\u836f\u54c1\u4e0d\u826f\u53cd\u5e94 (ADR)<\/li>\n<li><a href=\"https:\/\/lifesciences.csoftintl.com\/zh-hans\/%e8%8d%af%e7%89%a9%e8%ad%a6%e6%88%92\/\"><u>AEs\/Ars\/SAEs\/SUSARs (IEB\/IRB Correspondences)<\/u><\/a><\/li>\n<li><a href=\"https:\/\/lifesciences.csoftintl.com\/zh-hans\/%e5%8c%bb%e5%ad%a6%e6%a0%87%e8%ae%b0\/\"><u>\u533b\u7597\u8425\u9500\u6750\u6599<\/u><\/a><\/li>\n<li><a href=\"https:\/\/lifesciences.csoftintl.com\/zh-hans\/%e5%8c%bb%e7%96%97%e5%99%a8%e6%a2%b0\/\"><u>\u5305\u88c5\u5185\u9875\u548c\u6807\u7b7e<\/u><\/a><\/li>\n<li><a href=\"https:\/\/lifesciences.csoftintl.com\/medical-research-document-transation\/\"><u>\u533b\u5b66\u7814\u7a76\u6587\u4ef6<\/u><\/a><\/li>\n<\/ul>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row make_equal=&#8221;on&#8221; _builder_version=&#8221;4.5.3&#8243; background_size=&#8221;initial&#8221; background_position=&#8221;top_left&#8221; background_repeat=&#8221;repeat&#8221; hover_enabled=&#8221;0&#8243; custom_padding=&#8221;0px||||false|false&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;3.25&#8243; custom_padding=&#8221;|||&#8221; custom_css_main_element=&#8221;display: flex; || flex-direction: column; || justify-content: center;&#8221; custom_padding__hover=&#8221;|||&#8221;][et_pb_text disabled_on=&#8221;on|on|off&#8221; _builder_version=&#8221;4.5.3&#8243; text_font=&#8221;||||||||&#8221; text_font_size=&#8221;16px&#8221; header_font=&#8221;||||||||&#8221; header_3_font=&#8221;||||||||&#8221; header_3_text_color=&#8221;#ffffff&#8221; hover_enabled=&#8221;0&#8243; header_2_text_align=&#8221;center&#8221;]<a href=\"https:\/\/lifesciences.csoftintl.com\/zh-hans\/%e5%8c%bb%e7%96%97%e6%96%87%e4%bb%b6\/\"><u>\u4e86\u89e3\u66f4\u591a<\/u><\/a>\u5173\u4e8e\u6211\u4eec\u7684\u533b\u7597\u6587\u4ef6\u7ffb\u8bd1\u670d\u52a1\u3002<br \/>\n[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; _builder_version=&#8221;4.5.3&#8243; background_color=&#8221;#f9f9f9&#8243; custom_padding=&#8221;0|0px|0px|0px|false|false&#8221; locked=&#8221;off&#8221;][et_pb_row column_structure=&#8221;1_3,2_3&#8243; _builder_version=&#8221;3.25&#8243; background_size=&#8221;initial&#8221; background_position=&#8221;top_left&#8221; background_repeat=&#8221;repeat&#8221; custom_padding=&#8221;60px|0px|60px|0px&#8221; global_module=&#8221;175790&#8243; saved_tabs=&#8221;all&#8221;][et_pb_column type=&#8221;1_3&#8243; _builder_version=&#8221;3.25&#8243; custom_padding=&#8221;|||&#8221; custom_padding__hover=&#8221;|||&#8221;][et_pb_image src=&#8221;https:\/\/lifesciences.csoftintl.com\/wp-content\/uploads\/2022\/03\/ISO-2022-white.png&#8221; alt=&#8221;ISO-certified Academic Translations&#8221; title_text=&#8221;ISO-2022-white&#8221; align=&#8221;center&#8221; align_tablet=&#8221;center&#8221; align_phone=&#8221;&#8221; align_last_edited=&#8221;on|desktop&#8221; _builder_version=&#8221;4.5.3&#8243; max_width=&#8221;100%&#8221; custom_padding=&#8221;100px||||false|false&#8221;][\/et_pb_image][\/et_pb_column][et_pb_column type=&#8221;2_3&#8243; _builder_version=&#8221;3.25&#8243; custom_padding=&#8221;|||&#8221; custom_padding__hover=&#8221;|||&#8221;][et_pb_text _builder_version=&#8221;4.5.3&#8243; _module_preset=&#8221;default&#8221;]\n\n\n<h2>\u6570\u636e\u5b89\u5168<\/h2>\n<p>\u62e5\u670920\u591a\u5e74\u533b\u5b66\u7ffb\u8bd1\u7ecf\u9a8c\u7684CSOFT\u534e\u4e5f\u751f\u547d\u79d1\u5b66\u6df1\u8c19\u6570\u636e\u5b89\u5168\u5bf9\u6211\u4eec\u5ba2\u6237\u7684\u91cd\u8981\u6027\uff0c\u5f53\u6d89\u53ca\u5230\u4fdd\u5bc6\u95ee\u9898\u65f6\uff0c\u6211\u4eec\u4ece\u4e0d\u4f1a\u6389\u4ee5\u8f7b\u5fc3\u3002\u6211\u4eec\u62e5\u6709\u5b8c\u5584\u7684\u6587\u6863\u548c\u5b8c\u5168\u53ef\u8ffd\u6eaf\u7684\u4fe1\u606f\u5b89\u5168\u653f\u7b56\u3001\u68c0\u67e5\u8868\u548c\u8d28\u91cf\u8bb0\u5f55\u3002\u540c\u65f6\uff0c\u6211\u4eec\u7684\u64cd\u4f5c\u6d41\u7a0b\u4e0e <b>ISO 27001<\/b> \u63d0\u4f9b\u7684\u6700\u4f73\u5b9e\u8df5\u65b9\u5f0f\u4fdd\u6301\u4e00\u81f4\uff0c\u4fdd\u969c\u5ba2\u6237\u4fe1\u606f\u7684\u5b89\u5168\u3002\n<\/p>\n<p><span><a href=\"https:\/\/lifesciences.csoftintl.com\/zh-hans\/%e6%8a%80%e6%9c%af%e5%ae%89%e5%85%a8\/\"><u>\u4e86\u89e3\u66f4\u591a<\/u><\/a><\/span>\u5173\u4e8eCSOFT\u5982\u4f55\u4f18\u5148\u8003\u8651\u6570\u636e\u5b89\u5168\u7684\u4fe1\u606f\u3002\n<\/p>\n    [\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; 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