随着任何药物开发商知道，临床试验从多种来源产生了许多原始和电子数据。然而，在传统环境中跟踪来自每个单独数据库的结果，可以在传统环境中繁琐。这种“后视网膜”镜像监测方法不支持预防性计划，以减轻未来的风险，并可占试验成本的20-30％。
Recognizing the opportunity increase efficiency and deliver information faster,景created Xcellerate®Monitoring, a platform that integrates clinical trial data to help sponsors proactively decrease the inherent risks associated with clinical trials.
At a recent clinical seminar in China, Dimitris Agrafiotis, PhD, Vice President, Chief Data Officer discussed how Xcellerate Monitoring tracks quality, patient safety and protocol compliance in clinical trials.
Visualizing Risk
“Many sponsors, both in and outside of China, don’t have access to near real-time data,” said Agrafiotis. “They rely on a lot of reports and jump from tool to tool to get the job done. With Xcellerate Monitoring, we offer a very inviting user experience that supports embedded workflows so users can gain insights from analytic visualizations and take action.”
By looking at data both individually and collectively, Agrafiotis showed the audience in China how sponsors could better monitor risk areas by looking at both individual and collective data from operational, medical and statistical contexts.
“预先编程错误检查允许数据管理器辨别丢失，错误或不一致的数据，”Agrafiotis说，虽然风险监测允许临床试验管理员评估和减轻运营风险，例如患者筛查，入学或辍学的问题。以及协议偏差或审计结果。“
从医学角度来看，医生可以看到最新的结果，以更好地评估患者安全和其他可能损害审判完整性的临床问题。统计学人员也通过检查数据中的非随机异常来介绍，可以突出设备，流程或质量的问题。
从设计开始质量
使用Xcellerate监控不仅仅是运行平台。它涉及将质量建立到过程本身。“我们首先通过设计以质量为工程师，在研究中设计出风险，”Agrafiotis解释说。
这一过程涉及考虑到研究的复杂性并审查以前的网站质量和先前表现，计算研究，现场和业务水平的风险水平。通过评估本阶段的风险，更好地通知赞助商的策略来确定研究期间所需的源数据验证（SDV）和源数据审查（SDR）的数量和频率。
Intelligent, Targeted Intervention
Through a combination of remote and on-site monitoring, issues are identified and critical data processes are highlighted based on the levels of observed risk. “This allows central monitoring staff to efficiently direct site monitors to the right locations with the most optimal frequency to assure patient safety and data quality with greater speed and efficiency,” said Agrafiotis. Along with alerts and embedded notifications, sponsors are empowered to recognize issues and take action, faster.
较快的干预措施和更智能的监测，赞助商可以预期质量和节省成本的几个收益。在最近的一项研究中，观察到的景点：
- 20% less Critical/Major findings per clinical quality control (CQC) visit
- Higher levels of monitoring oversight per dollar spent on clinical monitoring activities
- 36％的场地管理支出和18％降低旅行支出
- 66% fewer missing eCRF Pages and 50% less SDV backlog at sites
这些有希望的度量标准显示Xcellerate Monitoring的质量和价值通过利用临床试验数据来带来任何研究。由于该技术继续在审判中产生差异，因此在监测和管理风险时，中国和全球市场的其余市场都可以预期更加数据驱动的决策。
Whether running a trial with Covance or another provider, Xcellerate Monitoring萨斯(software as a service) is available to sponsors in and outside of China or can be run or as part of larger set of solutions with the Xcellerate Clinical Trial Optimization®套房。Learn more.
