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全面的QT/QTC研究

在监管力度加强和研发环境改善的今天,与能提供优质稳定的ECG数据服务,并且在成功地设计、收集和提交TQT及密集QT数据方面拥有实力和经验的核心实验室合作是至关重要的。

BioClinica提供完整的TQT研究支持,包括分析概念方案设计、管理分析ECG数据以及撰写要提交给监管部门的报告。我们的心脏病学科副总Boaz Mendzelevski博士在传统或创新的TQT试验设计方面都具有丰富的经验。他设计的创新的TQT研究设计(阳性对照嵌入式交叉的平行组TQT研究设计),相对TQT研究中大型平行组设计方案,帮助申报者极大地缩减规模和成本。

我们的雄厚实力和丰富经验获得了全球范围的认可,已为日本的一项新药申请(NDA)成功地完成了首次受监管部门指定的TQT研究,也已完成了中国的首例监管部门指定的TQT研究。

BioClinica的TQT服务包括:

  • 包含完整的试验方案和统计分析计划(SAP)的研究设计
  • 先进的ECG数据获取、分析方法和设备
  • 执业心脏病专家的权威分析
  • 对向监管部门提交的材料(涉及FDA、EMA、PMDA和CFDA)给予专业指导
  • 可靠的质量保证,包括针对不同需求定制报告
  • 撰写中期批次报告
  • 为数据安全监测委员会提供各项支持
  • 专业的报告撰写
  • 创新的WebHeart为心脏安全数据管理提供`平台
  • 临床基地培训和持续的项目支持
  • 临床药理研究基地的识别

BioClinica认为,从治疗和监管的角度而言,并不是所有的药物都能够完成正式的TQT。我们的医学和科研团队拥有丰富的经验,并且熟知监管部门的要求,能为无法实施传统TQT研究的药物(如肿瘤治疗药物)提供有关QT心脏安全研究的解决方案。

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