Pharmacovigilance Automation
虽然使用药物理解自动化技术实现转型的概念适用于所有业务的各个方面,但我们处于创新技术是必需品的阶段,并实现令人信服的业务主张。
鉴于药物警戒(PV)的战略作用systems and the growing numbers of safety data sources and AE reports, technology solutions are already a vital cog in safety operations. Companies that recognize the importance of integrating newer, disruptive technologies and use them to fundamentally alter the drug safety continuum will see greater success in managing the safety of their products and maintaining cost-effectiveness.
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锻造自动化前进的道路
PV automation tools range from basic to robotic process automation, to cognitive and artificial intelligence (Figure 1), offering a wide variety of technology solutions that can be utilized to drive operational efficiencies across the PV continuum. At Covance, we understand the benefits that these automation tools offer and how our clients can take advantage of them.
Figure 1 – Covance PV Automation Tools and Roadmap
Basic Automationof a process workflow involves automatic tracking and monitoring of tasks and enables continuous metrics collection (e.g. literature tracking tool, workflow management).
文献跟踪工具摇来摇去m Covance is a comprehensive repository for literature abstracts and tracks the entire literature monitoring workflow. It provides real time dashboards and enables online review of the abstracts with links to the original full page article.
The Case Processing Assist tool (C-PAT) tool is a highly customizableRobotic Process Automation (RPA)用于辅助案例数据流入Argus,Arisg或任何自定义数据库的工具。它自动为结构化源文档自动化数据输入,并确保提高质量和效率。它还用作达到一个触摸箱处理的平台,涉及通过案例提交的案例摄入的单轮手动交互。
我们的进气处理辅助工具(I-PAT)工具完成所有携带的活动,以便进行案例处理。这需要在两个系统上进行三级重复搜索,从源文档的结构化字段解析信息和自动数据输入到数据库。这些信息由消费者呼叫中心,社交媒体和其他消费者面对平台收集,并由我们的全球案例管理团队使用。
The Medical Review Assist tool takes the automation process one level up to认知自动化。它支持医疗审阅者或安全医生,审查安全源文件和其他安全数据。该工具应用自然语言处理,以帮助识别药物事件对,同时利用现有的医学术语分类,例如医学术语(Meddra)和世界卫生组织的医学词典(WHODD)。
人工智能包括利用人工智能技术,如机器学习和深度学习的工具和系统组成,以自学和自动列车,因为它们处理了不断增长的安全数据量。这种AI工具与RPA和认知计算相结合,使端终的承诺具有最小或没有人为干预的最终自动化。
Operational Benefits
- 通过增强的生产力,预期效率升高的高达50%
- 高度可定制和数据库不可知论
- Improved quality through standardized inputs
- 100% regulatory compliance and faster turnaround time (TAT)
- Automated case intake and case processing
战略福利
- Standardization and automation of PV processesand safety data management through integration of safety data by application of appropriate data and system interoperability standards, implementation of best practices and technological concepts including work flow management technology to ensure appropriate transparency and accessibility of safety information and targeted automation for enhanced PV.
- 主动PV和风险最小化通过实施数据挖掘技术来识别和预测新出现的安全信号,以加强安全分析,报告和调查。更快的信号裁决和报告和管理提供了实时安全摘要,促进了对投资组合的及时对安全风险的认识,并及时执行安全风险最小化活动。
- Open and transparent data sharing with regulators, prescribers andpatients will build public trust and confidence, encourage greater openness across the industry, and promote impartial comparisons of alternative products. This will drive more trust, collaboration and ultimately fewer ADRs