外部供应商数据交换
Get cleaner non-EDC vendor data, faster
Ditch the spreadsheets and automate spec validations!
Since non-CRF data now accounts for over 70% of trial data, you likely work with lots of different vendors. So you create lots of data transfer specs. Get them agreed. But you still end up with dirty data! With with only email chains and spreadsheets to rely on there’s no audit trail. Just a lot of back and forth and manual work to get issues resolved. And a real risk of end-of-study delays. Sound familiar?
The Pinnacle 21 Enterprise (P21E) Data Exchange platform has everything you need to ease and accelerate vendor data reconciliation! Work together with vendors in one collaborative platform – which validates deliverables against specs for you. Hold vendors to a higher standard with collaborative tools for issue resolution, and a transparent audit trail. Now it’s possible to get cleaner data from vendors, in a much shorter timescale…
Why do external data reconciliation in Pinnacle 21 Enterprise?
轻松创建数据传输 SPECs
The P21E platform lets you collaboratively create, manage and validate specifications in real-time. 相关团队可在一个中心位置轻松审查和编辑 SPECs,而无需再浏览多个电子表格和电子邮件链!
标准化和重复使用 SPECs
Establish a central library of reusable standards for non-CRF data collection. 这项艰巨的工作只需完成一次,然后就可以将规格标准化,并在后续研究中重复使用。因此,在供应商规格制定过程中可以节省大量时间。
确保质量和合规性
在通过安全文件传输发送供应商数据的过程中,将根据您的规范对交付成果进行验证,包括对结构、代码表和值进行检查。这种流内验证可提供可操作的问题清单,供供应商实时审查。因此,从一开始就能确保交付高质量、整洁、合规的产品。
快速解决问题
拥有一个供内部和外部团队协同管理数据的中央平台,可以大大缩短时间。Vendors can easily see and address non-EDC data issues, and all teams can collaborate transparently to resolve issues much faster.
一站式协作
只需在一个中心位置,即可审查、编辑和重复使用 SPECs,管理问题以及接收和验证供应商数据。可以提供多种类型的文件,包括 CSV、SAS 数据集和 Excel 文件,还可以集中管理相关人员的访问权限。
内置仪表盘
P21E provides a valuable source of metrics and analytics to aid decision making. 仪表盘提供了跨治疗领域、项目、研究和供应商的详细指标。跟踪规格制定、数据交付和问题解决的周转时间。甚至还能监控传输文件质量并自动执行工作流程。
How to get cleaner, more compliant data from external labs and vendors
How you’re better off with P21E
缩短时间,提高供应商的质量
避免数周甚至数月等待供应商数据。流程内验证从一开始就能确保交付更高质量的产品。And external data reconciliation tools massively reduce issue resolution timelines. 据一家排名前十的制药公司报告,使用我们的平台后,平均每项研究每年可节省 400 个操作小时!
简化流程,提高效率
有了一个用于协作和沟通的中央平台,需要使用和支持的系统就会减少。数据传输和通信不再需要众多门户网站,而是将一切简化为 "单一真相源"。最终,所需的努力和资源都会减少,特别是在重复使用标准的情况下。
提前决策,加速药品上市
有了可重复使用的供应商数据收集标准,并能更快地审查干净的数据,就能提前进行分析并做出明智的决策。因此,申办方可以比以往任何时候都更快地推出改变生活的新药,并开始获得收益。
One top pharma client averaged 50-75% time savings on data transfer spec review!
Get higher quality non-CRF vendor data with
Pinnacle 21 Enterprise
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资源
External data reconciliation FAQs
Non-CRF data refers to the collection of electronic data from external sources in clinical trials. This is data collected outside the EDC system (electronic data capture system) and it’s often referred to as Non-CRF data, third-party vendor data, Non-EDC data, and external data reconciliation.
Examples of Non-CRF data in clinical trials includes lab data, wearables data, medical images, and ePRO’s (electronic patient-reported outcomes). Non-CRF data is crucial in determining the safety and efficacy of new drugs being trialed.
External data reconciliation or lab data reconciliation refers to the process of comparing Non-EDC data against data held in the clinical database, and against the agreed data transfer specifications. For example, 3rd party vendor data must be verified against the agreed structure, codelists, and values.
Non-CRF data can be reconciled manually, although it does pose certain challenges and risks related to human error. For example, there’s a greater chance of inaccuracies, inconsistencies, duplications and gaps being missed in manual checks. However, standardization of Non-EDC data and robust data management using an electronic vendor data reconciliation tool can resolve these challenges. You can read how one sponsor is handling external data reconciliation here >>