2022年数字化临床试验行业研究报告-动脉橙

数/r/n字化临床试验行业研究报告/r/n/r/n前/r/n/r/n言/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n10/r/n/r/n18/r/nT/r/nS/r/n/r/n33/r/n/r/n34/r/n/r/n36/r/n/r/n/r/n/r/n/r/n /r/nO/r/n/r/n/r/n优化对象/r/n要优化途径/r/n要优化结果/r/n将记录在纸/r/n上的数据转为电子化，/r/n/r/n以电子/r/n/r/n无纸化节约了存储空间/r/n/r/n、数据存储时效和/r/n/r/n文档形式存储在/r/nu/r/n盘、光盘/r/n中/r/n/r/n安全性更有保障、交换更方便/r/n化/r/n数据产生来源/r/n/r/n(/r/n受试者/r/n/r/n、操作者/r/n/r/n、使用设/r/n/r/n数据产生流程可视化/r/n/r/n、可回溯，/r/n/r/n提高管理/r/n/r/n备/r/n等/r/n/r/n)/r/n/r/n、/r/n/r/n方式/r/n/r/n、过程等体现在软件系统/r/n/r/n者对数据质量的把控和监查效率，/r/n/r/n减少人/r/n/r/n织内部使用)/r/n数/r/n字化/r/n/r/n数据、流程/r/n在信息化基础上，/r/n/r/n建立/r/n参与各方认同的数/r/n/r/n数据和流程互联互通，/r/n/r/n参与各方形成新的/r/n/r/n/r/n登录获得需要的数据并查看/r/n/r/n、/r/n执行和更新/r/n/r/n重复录入/r/n/r/n、确认等工作环节，/r/n/r/n减少工作量/r/n深/r/n深/r/n度/r/n挖掘数据价值，/r/n/r/n基于对已有数据的分/r/n/r/n传统基于经验的决策在科技支持下，/r/n/r/n变为/r/n智/r/n能化/r/n/r/n数据、流程/r/n/r/n析和理解，/r/n/r/n建立算法提供辅助决策的相应/r/n/r/n更有依据且对个人能力依赖更低的决策方/r/n数据信息/r/n/r/n/r/n式，/r/n/r/n同时提高决策准确性/r/n脉网，蛋壳研究院制/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n数/r/n量/r/n/r/n(个)/r/n项目均/r/n价/r/n/r/n(万元)/r/n市场/r/n规/r/n模/r/n/r/n(万元)/r/nE/r/n数/r/n量/r/n/r/n(个)/r/n项目均/r/n价/r/n/r/n(万元)/r/n数/r/n数/r/n量/r/n/r/n(个)/r/n项目均/r/n价/r/n/r/n(万元)/r/n国家药品监督管理局药品审评中心、创新工场，蛋壳研究院制/r/n/r/n/r/n/r/n/r/n/r/n国家药品监督管理局药品审评中心、创新工场，蛋壳研究院制/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n驱动方/r/n面/r/n间/r/n政/r/n策发布部门/r/n政策名称/r/n相/r/n关重点内容/r/n监管/r/n国家药监局/r/n《关于开展药物临床试验数据自查核/r/n查/r/n/r/n工作的公告》/r/n要求1622个已申报生产或进口的待审药品注册申请药/r/n物/r/n/r/n临床试验/r/n情况开展自查，/r/n/r/n确保临床试验数据真实、可/r/n/r/n国家/r/n市场监督/r/n/r/n管理总/r/n局/r/n《药品注册管理办法/r/n》/r/n确定药品注册管理的主要/r/n框架，/r/n/r/n对不同监管部门机构的/r/n/r/n权/r/n责/r/n给出更加明确的规定。/r/n/r/n国家卫健委/r/n《/r/n药物临床试验质量管理规范》/r/n/r/n国家药监局/r/n《关于开展化学药品注射剂仿制药质/r/n量/r/n/r/n和/r/n疗/r/n效一致性评价工作的公告》/r/n已上市的化学药品注射剂仿制药，/r/n/r/n未按照与原研药/r/n品质/r/n/r/n量和疗效一致原则审批的品种均需开展一致性评价/r/n。/r/n国家药监局/r/n《临/r/n床/r/n试验的电子数据采集技术/r/n/r/n指导原则》/r/n给出/r/n了/r/nEDC/r/n的定义、使用规范并提出了技术和应用的基/r/n/r/n本/r/n要/r/n求。/r/n数字化/r/n国家/r/n药审中心/r/n《新冠肺炎疫情期间药物临床试验管/r/n理/r/n/r/n指导原则》/r/n可尝试选择远程智/r/n能临床试验方法，/r/n/r/n借助智能化临床试/r/n/r/n验管理平台及远程通讯技/r/n术，/r/n/r/n以受试者为中心开展临床/r/n/r/n试验/r/n。/r/n国家/r/n药审中心/r/n《以临床价值为导向的抗肿瘤药物临/r/n床/r/n/r/n研发指导原则/r/n》/r/n建/r/n议抗肿瘤药物临床试验设计中可以考虑加入去中心化/r/n/r/n临/r/n床试验的设计元素。/r/n国家/r/n药审中心/r/n《以患者为中心的临床试验实施技术/r/n指/r/n/r/n导/r/n原则/r/n/r/n(征求意见稿)/r/n/r/n》/r/n为了实施更加/r/n可及、友好、便利的临床试验，/r/n/r/n指导原则/r/n/r/n提/r/n出了多个以患者为中心的新技术、新方法、新模式应/r/n/r/n用/r/n场景。/r/n创/r/n新药/r/n国务/r/n院办公厅/r/n《/r/n药/r/n品上市许可持有人制度/r/n/r/n试/r/n点方案》/r/n实行/r/n药/r/n品上市许可与生产许可分离管理。/r/n中共/r/n中/r/n央办公厅/r/n/r/n、国务院办公厅/r/n《关于深化审评审批制度改革鼓励药/r/n品/r/n/r/n医疗器械创新的意见/r/n》/r/n/r/n和仿制药发展，/r/n/r/n加强药品医疗器械全生命周期管/r/n理。/r/n国家医保局/r/n《关于将17种药品纳入国家基本医疗保/r/n/r/n险、/r/n工/r/n伤保险和生育保险药品目录乙类/r/n范围的通知》/r/n1/r/n7种抗癌药纳入国家基本医疗保险、工伤保险和生育保/r/n/r/n险/r/n药/r/n品目录乙类范围。/r/n/r/n人/r/n社局/r/n关于/r/n将/r/n2019年谈判药品纳入《国家基本/r/n医/r/n疗保险、工伤保险和生育保险药品目/r/n医/r/n疗目录纳入阿达木单抗、/r/nPD/r/n-1抑制剂信迪利单抗等多/r/n/r/n个/r/n重磅创新药品种。/r/n国家药监局/r/n2020年新版《药品注册管理办法/r/n》/r/n/r/n获得优先审批待/r/n遇，/r/n/r/n具有较高的自主定价权、准入通道/r/n/r/n畅通/r/n。/r/n驱动方/r/n面/r/n间/r/n政/r/n策发布部门/r/n政策名称/r/n相/r/n关重点内容/r/n行/r/n业/r/n国务院/r/n《国务院办公厅关于开展仿制药质量/r/n和/r/n/r/n疗/r/n效/r/n一致性评价的意见》/r/n明确指出289种化学药品仿制药口服固体制剂原则上/r/n应/r/n/r/n在2018年底前完成一致性评价/r/n。/r/n国务院/r/n《/r/n国/r/n家组织药品集中采购试点方案》/r/n明确了/r/n国家组织、联盟采购、平台操作的总体思路。/r/n国家药监局/r/n《国家药品监督管理局关于调整药物/r/n临/r/n/r/n床试/r/n验/r/n审评审批程序的公告》/r/n明确了默示许可制度适用的细则，/r/n/r/n包括明确默示许可的/r/n/r/n期限、审评审批的具体方式、沟通交流会议的安排等/r/n。/r/n/r/n国家卫健委/r/n《/r/n药物临床试验机构管理规定》/r/n药/r/n物/r/n临床试验机构实行备案管理。/r/n国家药监局/r/n《真实世界证据支持药物研发与审评/r/n的/r/n/r/n指/r/n导原则/r/n/r/n(试行)/r/n/r/n》/r/n厘清药物/r/n研发和监管决策中真实世界证据的相关定义，/r/n/r/n指导真/r/n实/r/n世界数据收集以及适用性评估。/r/n国家/r/n药审中心/r/n《真实世界证据支持儿童药物研发与/r/n审/r/n/r/n评/r/n的/r/n技术指导原则/r/n/r/n(征求意见稿)/r/n/r/n》/r/n推动真实世界证据在儿/r/n童药物研发中的应用和落地，/r/n/r/n适/r/n/r/n用于化学药品、/r/n/r/n中药及生物制品等各类别儿童/r/n用药。/r/n脉橙数据库，蛋壳研究院制/r/n/r/n/r/n/r/n/r/n多/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n一生物科技)/r/n/r/n、遥领医疗科技、有临医药等专/r/n/r/n/r/n/r/n/r/n服务类型/r/n/r/n企业名称/r/n资机构/r/n/r/n/r/n太/r/n美医疗科技/r/n、常春藤资本、凯风创投、/r/n/r/n软银中国、五源资本、浙商创投、凡卓/r/n资本、/r/n经纬中国、未/r/n来启创基金/r/n/r/n/r/n软银中国、五源资本、浙商创投、赛富/r/n投资/r/n/r/n五源资本、浙商创投/r/n、赛富投资/r/n科技/r/n中金资本、优山/r/n资本、津南海河宽带智汇产业基金/r/n公司/r/n投资/r/n斯道资本、富海万盛、蓝/r/n湖资本/r/n东方富海、斯道资本、蓝/r/n湖资本/r/n银河吉星、/r/n和悦资本/r/n元/r/n明创投/r/n、春华创投、/r/n/r/n上海人工/r/n智能产业基金/r/n轮/r/n元/r/n光速中国/r/n、汉康医药/r/n康/r/n夏尔巴、红杉中/r/n国、钟鼎资本/r/n元/r/n国/r/n元/r/n资本/r/n泰雅资本、博行资本、海金格医/r/n药/r/n元/r/n红杉资本中国基金、杭/r/n州和达投资/r/n药明/r/n康德、泰格医药/r/n启明创投、/r/n恩然创投/r/n元/r/n速医疗/r/n科林利康/r/n软件/r/n伊柯夫科技/r/n元/r/n技/r/n元/r/n金沙江创投、红杉资本中国基金、真格/r/n基金/r/n务类型/r/n企业名称/r/n资机构/r/n/r/n/r/n//r/n化成/r/n//r/n//r/n//r/n公司/r/nGGV/r/n钟鼎资本、经纬中国/r/n元璟资本、/r/n/r/n元生/r/n资本、经纬中国/r/n元璟资本、/r/n/r/n元生/r/n资本、经纬中国/r/n元生资本、经纬中国/r/n、元璟资本/r/n经纬中国/r/n、元璟资本/r/n药/r/n元/r/n苏/r/n高新创投集团/r/n、创新工场、/r/n/r/n翼朴/r/n资本、麦星投资/r/n创新工场、/r/n麦星投资/r/n沃生投/r/n资、辰德资本/r/n金慧丰投资、/r/n普华资本/r/n金慧丰投资、/r/n普华资本/r/n印医疗基金/r/n投资/r/n学/r/n启明创投、道禾志医、思科瑞新、博行资/r/n本/r/n元/r/n博行资/r/n本、拓金资本/r/n临医药/r/n上/r/n海联和投资,瑞华控股/r/n钟鼎资本、千骥资本、仁/r/n金投资/r/n千骥资本、道禾长期投资、/r/n贞吉资本/r/n桃计算机/r/n元/r/n创新工场、/r/n沂景资本/r/n圣/r/n方医药研发/r/n洲嶺资本、创新工场/r/n、周大福/r/n领医疗科技/r/n华颖投资/r/n/r/n(/r/n中国/深圳)/r/n数据来源：动脉橙数据库，蛋壳研究院制(按融资轮次排序，轮次相同按融资时间/r/n排序)/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n脉网，蛋壳研究院制/r/n/r/n/r/n、/r/n/r/n/r/n/r/n/r/n形式/r/n交付标/r/n准/r/n预/r/n期使用目的/r/n通/r/n用型产品/r/n产/r/n品/r/n定/r/n制型产品/r/n软/r/n件系统/r/n /r/n(/r/n有时配以相应硬件)/r/n按/r/n需/r/n定制的软件系统及硬件设备/r/n软硬件现场部署/r/n①/r/n软硬件定制开发/r/n②/r/n软硬件现场部署/r/n软/r/n硬件能正常被相关/r/n从业人员使/r/n用/r/n①/r/n①/r/n完成临床试验单个或多个/r/n/r/n环/r/n节工作/r/n②产出有/r/n质量保证的结果，/r/n/r/n达/r/n到降本增效的目的/r/n脉网，蛋壳研究院制/r/n①软硬件定制开发/r/n/r/n(可选/r/n)/r/n②/r/n软硬件现场部署/r/n③/r/n现场运营、使用人员/r/n④/r/n按协议产出相应试验结果/r/n①软件系统/r/n/r/n(配以相应硬件/r/n)/r/n②/r/n软/r/n硬件相关的运营、使用服务/r/n解/r/n决方案/r/n/r/n项目较/r/n少或经费有限的/r/n/r/n使用时长/项目数/r/n量/r/n /r/n(如按年付费)/r/n固定/r/n用门槛/r/n低/r/n低/r/n制/r/n件或硬件的/r/n量/r/n根据配置等级/r/n有一定波动/r/n高/r/n项/r/n目或经费较充足/r/n低/r/n/r/n /r/n(/r/n单个或多个环节)/r/n高/r/n根据试验人/r/n数波动较大/r/n高/r/n脉网，蛋壳研究院制/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n企/r/n企/r/n业类型/r/n传统/r/nCRO/r/n企业转型/r/n部/r/n分环节CRO企业/r/n创新型数字化/r/nCRO/r/n企/r/n业/r/n简介/r/n传统/r/nCRO/r/n企业进行/r/n数/r/n字化升级/r/n仅/r/n提供临床试验部分/r/n环节的CRO服务/r/n既提供/r/n技术也提供临床/r/nCRO服务/r/n覆盖临床试/r/n覆盖临床试/r/n验/r/n全流/r/n程/r/n全流/r/n程/r/n优/r/n势/r/n丰富的/r/n临/r/n床试验经验、/r/n所/r/n服务环节资源充足/r/n数/r/n字化产品技术实力/r/n数/r/n字化思维/r/n企/r/n企/r/n业举例/r/n药明康德、康龙化成/r/n、/r/n厚普/r/n医/r/n药、京东健康等/r/n/r/n艾莎医/r/n学/r/n、遥领医疗科技等/r/n脉网，蛋壳研究院制/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n /r/n产品系统/r/n验前/r/n立项/r/n立项/r/n/r/n伦理/r/n动/r/n/r/n验中/r/n/r/n/r/n/r/n查/r/n/r/n验后/r/n随/r/n机化和试验供应管理/r/n药物警戒系统/r/n患者报告结局/r/n系统/r/n项目管/r/n理系统/r/n研究者筛选系统/r/n受试者/r/n招募系统/r/n影像/r/n阅片系统/r/n药物管理系统/r/n培训系统/r/n远程监/r/n查系统/r/n人力成本核算、/r/n绩效系统/r/n院协作平台/r/n数据管理与分析/r/n系统/r/n脉网，蛋壳研究院制/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n脉网，蛋壳研究院制/r/n/r/n/r/n/r/n/r/n/r/n /r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n试验供应管理/r/n/r/n/r/n试验/r/n的科学性。/r/n患者随机性、药品分配/r/n、药品/r/n/r/n。/r/nE/r/n/r/nSAE/r/nE/r/n/r/nSAE/r/n。/r/n/r/n/r/n文件追踪、/r/n稽查留痕等。/r/n脉网，蛋壳研究院制/r/n/r/n/r/n/r/n脉网，蛋壳研究院制/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n工作/r/n工作/r/n流程/r/n①登录医护人员相/r/n关账号/r/n/r/n(独自或与其一同)/r/n②/r/n数据拍照或数据拷贝/r/n待/r/n提升点/r/n工作/r/n内容/r/n获取数/r/n据/r/n①时/r/n间/r/n成本高：/r/n/r/n院内外数据存储逻辑不同需人工查找识别/r/n/r/n信/r/n息识别有误差/r/n核对数/r/n据/r/n①获得可/r/n浏览院内系统相关数据的账号/r/n②查找原/r/n始数据并与/r/nEDC/r/n相应模块数据对比/r/n①/r/n合规隐患：/r/n/r/n患者隐私保护/r/n②时间成/r/n本/r/n高：/r/n/r/n需逐一搜索相关数据并核对/r/n脉网，蛋壳研究院制/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n数据抓/r/n取/r/n数据处/r/n理/r/n数据应/r/n用/r/n数据抓/r/n取/r/n数据处/r/n理/r/n数据应/r/n用/r/n/r/n/r/n/r/n数据留/r/n数据留/r/n痕/r/n技/r/n术难度/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n是/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n产/r/n品/r/n临床/r/n研究管理系统/r/n/r/n介/r/n/r/n/r/n见模块/r/n中心管理、进度管理、风险管/r/n理/r/n、/r/n财务/r/n管理、人员管理等。/r/n受/r/n试者招募系统/r/n/r/n/r/n间/r/n潜在受试者快速触达。/r/n关键词/r/n搜索、复杂条件搜索、/r/n二次/r/n筛选等。/r/n研究者及/r/n中心选择系统/r/n从多数据维度/r/n/r/n(如项目数量、研究方向及潜在受试者数量)/r/n/r/n对研究者及中/r/n/r/n/r/n复杂条件搜索、风险把控、/r/n/r/n在线合/r/n同/r/n生成及签署等。/r/n远/r/n程监查系统/r/n/r/n数据进行监查、发现问题、汇报及提/r/n出解决方案等。/r/n/r/n报告/r/n形成、问题汇总等。/r/n影像阅片系统/r/n/r/nAI/r/n质控、随机盲法、/r/n/r/n精准评估/r/n、实时报表等。/r/n者/CRC/r/n/r/n沟通/r/n类系统/r/n/r/n电子/r/n问/r/n卷、用药提醒、/r/n/r/n科普知识、/r/n咨询功能等。/r/n工作人员绩/r/n效/r/n核算系统/r/n/r/n效。/r/n脉网，蛋壳研究院制/r/n/r/n/r/n/r/n脉网，蛋壳研究院制/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n根据亿欧智库数据估算，蛋壳研究院制/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n/r/n群/r/n/r/n/r/n/r/n传统受试者触达/r/n/r/n/r/n数字化受试者触达/r/n受/r/n试者来源/r/n受/r/n试者范围/r/n受/r/n试者筛选/r/n达效率/r/n触达/r/n精准度/r/n环节/r/n把控度/r/n研究者/r/n研究者/r/n们的患者群体/r/n 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