一些问题要思考……如果您每6周削减100％的SDV或CRAS访问网站，您是否觉得您的审判会更有危险？如果我们没有遇到错过的不良事件或更重要的事情怎么办？SAE，质量问题？基于风险的方法是否会有更高的风险？好吧……如果您正在使用自动化的可追溯性数据以使这些潜在问题得到缓解，该怎么办？

Gone are the days of subjects having to come into the office to complete all assessments – manually, more often than not.. Thank goodness as this eases subject and site burden and allows for increased enrollment opportunities in a trial. The ability to adapt as a result of a pandemic has accelerated clinical trials into a new paradigm. The MHRA has even come onboard stating, "The ICH GCP statement that, 'in general there is a need for on-site monitoring before, during and after the trial' is not recommended to be interpreted that on-site visits for assessment, initiation and on-going monitoring and closeout must always be performed."¹Wow, does this open the door for a risk-based approach and for all of us to feel more comfortable?!

通过基于风险的接近，现场监视日的数量减少了放松站点，试用成本和赞助商负担。疑问的日子已经过去几个月了。网站涉及数据责任的合同协议 - 或至少与非基于非风险的方法试验相比，他们更迅速地通知了违规行为，从而导致了一个更快乐的项目团队。至少要解决的一个不太沮丧的问题！

Did you catch that key word earlier? Automation! The SaaS-based cloud system starts with Quality by Design at the Protocol Design step, however, can be implemented even later for trials already being conducted. Starting with libraries of therapeutically aligned configurable risks leveraged by IQVIA's over-12-years-of-risk-based experience, the system enables Integrated Monitoring across all of the roles that need to monitor data within the trial with insight as to what other roles are monitoring. Oversight is at the forefront of every trial.

审查试验中的数据，站点和主题级别提供了确定触发站点联系的趋势和问题所需的整体数据（查询，远程访问等），远程和/或现场监视访问（以及MHRA的限制！）。问题识别可以使动态，质量监控。这并不意味着未经监视站点，而是对其进行监视all of the data on the trial risk planthrough the integrated monitoring strategies and based on the risks identified both predictive and actual. Issue prevention is paramount! Can you imagine being able to identify the majority of protocol deviations at the beginning of the trial and how prompt remediation can reduce ongoing deviations? The overall numbers of protocol deviations in a risk-based approach are significantly less- 50% less- as documented through IQVIA's proof points.

数据智能的数据素养是系统的指导，并由项目咨询（如果需要）支持。它简化了对自学成才的依赖，并可能不准确评估。用户友好和可配置的分析支持趋势和各个级别的发行识别，无论是通过医疗团队与数据管理与CRA的审查。

使用与您的员工配置的基于SaaS的产品。这是与客户系统集成，适合任何试用规模的端到最终解决方案，并且是您进行试用的机会！

¹MHRA's指导监督和监视活动