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服务质量

BioClinica 心脏安全研究领域的首选

BioClinica是一家在全球范围内提供医学影像分析以及全方位的心电安全服务,拥有行业领先的学术水准的服务机构。在注重数据的准确性以及符合注册要求的同时,我们各医学领域及学科上的专家组更能根据不同的需求提供个性化的服务。凭借30多年来的行业经验以及数以千计成功的临床试验,我们的服务能有效缩短您在药品或器械的研发过程所投入的时间。我们遍布美国、欧洲乃至亚洲的医学影像及心血管核心实验室拥有最前沿的科技,完全符合注册要求,能够为各领域的临床研究提供广泛的支持。

BioClinica的与众不同之处:

  • 30多年为数千例临床试验提供支持的丰富经验
  • 各临床学科的医学和科学研究领域的专家
  • 与关键意见领袖(KOL)的广泛合作
  • 遍布全球的办公分支及客户群体
  • 符合FDA规范的运作流程
  • 从方案撰写到注册申报,全面支持整个临床试验周期的任一环节。

我们的业务和技术可为您提供高质量、无偏差的医学影像诊断

  • 制订试验方案及影像诊断章程(IRCs)以确保符合当地法规要求
  • 与申办方及药理基地的高效沟通确保方案的正确执行及项目的准时完成
  • 健全的质量控制和数据核实流程,确保能获得高质量的影像数据
  • 定制技术平台以兼容特定试验的复杂成像终端
  • 由全职的医师和关键意见领袖(KOLs)做出独立的专业影像诊断
  • 依照《美国联邦法规》(CFR)21章第11条规定整核和归档所有的数据

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Leader in Clinical Trial
Management Solutions

Successful clinical trials require the ability to see key details and uncover hidden insights. Bioclinica utilizes science and technology to bring clarity to clinical trials, helping companies to develop new life-improving therapies more efficiently and safely.

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