iDrugSafety™ - MedSci Healthcare

满足最新法规要求
  • SAE报告导出
  • 国家市场监督管理局报告导入
  • 支持标准数据直报
  • 符合NMPA/FDA/EMA法规要求
 
符合国内国际标准
  • ICH E2B数据交互标准
  • 21 CFR 系统基础标准
  • 支持MedDRA, WHOArt, WHODRUG等国际标准医学/药物编码
  • 获得GAMP5,CMM3系统验证
  • 标准报告导出
 
人工智能赋能
  • PSUR报告自动生成
  • 整合商业智能系统支持自定义表单,辅助决策
  • SAE报告自动生成
  • 个例报告中英智能翻译
  • CFDA反馈报告自动生成
 
系统和服务灵活配置
  • 功能模块模块灵活配置
  • 工作流可根据企业SOP灵活配置
  • 支持云服务和本地部署
  • 多种药物紧急服务配合主系统提高药物警戒效率
 

 

Intelligent Pharmacovigilance System iDrugSafety™

Comprehensively integrates drug safety data, utilizing artificial intelligence to improve the efficiency and quality of pharmacovigilance.

 
  • Multi-channel Information Collection

  • Fully utilizes the latest technologies to integrate PC, WeChat, mini-programs, and mobile applications, creating multi-channel data collection pathways, including spontaneous reports, literature reports, feedback information, follow-up information, call centers, clinical trials, etc.
  • 360-degree Pharmacovigilance Service

  • Core to iDrugSafety®, a professional pharmacovigilance function, providing comprehensive pharmacovigilance services from information collection, case handling, report writing and submission, compliance review, and more.
  • Compliant with International and Domestic Regulations

  • Based on ICH pharmacovigilance guidelines, covering the entire lifecycle of drugs and devices from clinical trials to post-market, fully compliant with pharmacovigilance regulations in China, the USA, the EU, and ASEAN.
 

iDrugSafety™ 申请试用

 

梅斯医学iDrugSafety™是基于华为云的药物警戒信息系统,可以快速部署,符合规范,提高效率,为您的药物警戒工作助力

 

请填写您的真实信息,我们的专属私人客服将在1-2天内与您联系

您也可以邮件至:pv@medsci.cn 

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