Pinnacle 21 – Clinical Metadata Repository
利用我们的临床元数据存储库，以更快的速度和更高的质量开展研究
在我们的临床 MDR 中定义、重复使用和管理标准
一切从标准化开始。制定好标准，就能为更快获得高质量的临床试验数据铺平道路。学习构建和复习周期只需几天，而不是几周。因此，病人登记注册的时间可以大大提前。
The Pinnacle 21 Enterprise (P21E) clinical metadata repository (CMDR) provides a central cloud platform to author, share, reuse and govern standards. And with our clinical MDR as your foundation, you can drive EDC and SDTM automation downstream, to optimize trials even further.
我们见证了各组织将研究设置时间从 15 天缩短至 2 天！
为什么要实施临床 MDR？
更快地构建学习环境
CMDR 中可重复使用的验证标准可节省研究设置时间。现在，在 6 周内完成研究项目是可能的！
改善管理
通过在 CMDR 中定义治理工作流程，获得学习内容开发的可见性和控制权。
更高的质量
拥有一个经过批准和验证的标准库，可确保在今后的研究和标准中使用内容时的质量和一致性。
轻松实现 CDISC
合规性
A CMDR provides the assurance of CDISC standards compliance, with built-in compliant templates for designing new content, and error prompts along the way.
通过影响可见性做出明智决策
了解潜在的更改将如何影响您的 MDR 中的相关标准和研究，以便您做出更明智的决策。
通过完全可追溯性确保数据完整性
在试验的整个生命周期内，对标准和研究的访问和更新情况实现完全可视化，并提供完整的审计跟踪，实现完全透明。
Build studies up to 85% faster with the Pinnacle 21 Enterprise
Clinical MDR
How you’re better off with P21E’s Clinical Metadata Repository
提前开始试验，加快药物上市
通过临床 MDR 触发更快的研究设置和 EDC 自动化，可以更早地开始患者注册。一些组织已将学习构建时间从 15 天减少到仅 2 天！我们看到审查周期缩短了一半，从 8 天缩短到 4 天。因此，试验可以更快地进行，救命药物也可以更快地投放市场。
降低成本，提高生产力
由于您主要是重复使用经过验证的标准来建立研究，因此需要的人工工作和资源都更少。技术资源可以调配到其他地方，这意味着研究设置更具成本效益。
最大限度地增加申请获得批准的机会
With validated, high quality standards in your clinical metadata repository, you know that the content you’ll reuse already complies with CDISC and other regulatory regulations. 这样，您就可以顺利通过审核了！
轻松构建临床研究
With the clinical MDR underpinning our platform, you can automatically build your EDC from standards in P21E.
1.
利用预定义或定制的工作流程，在 CMDR 中制定组织标准并获得批准。
2.
Select relevant content from standards in your clinical metadata repository to build a study (e.g. forms, datasets, SDTM mappings).
3.
添加任何所需的访问时间表、自定义编辑检查、自定义映射等。在临床 MDR 中对您的 EDC 进行可视化研究。
4.
根据内部和监管标准验证您的研究，确保合规。
5.
Build a study for your chosen EDC from the Pinnacle 21 Enterprise platform. 生成提交材料和所需数据集。
客户对我们的评价
What are the benefits of standardization, and is it worth it?
Watch this webinar to learn the efficiencies gained by implementing standards, and the before/after results you could achieve.
资源
Clinical Metadata Repository FAQs
Clinical metadata refers to the metadata used in clinical trials. Study data is the raw patient data collected during a trial. Metadata describes or provides information about the study data. It gives context to the data and provides a deeper understanding of the data. For example, dataset metadata provides context about the properties of a dataset, such as dataset name, label, and class. Variable metadata provides information about variable properties, such as format, type and controlled terminology.
Metadata is information that describes or explains the data collected during a clinical study. Metadata is often referred to as ‘data about data’. Clinical metadata management refers to the process of collecting, seeing, updating, cleaning, and managing clinical trial metadata.
A clinical metadata repository (also known as a clinical MDR) is a cloud based software tool to help data management professionals locate documents and data related to a clinical study. It’s a library for storing, sharing, managing and reusing standardized metadata assets, such as forms, datasets, terminologies and mappings. A clinical metadata repository is often referred to as a ‘single source of truth’ since it provides a centralized location for all relevant clinical trial metadata. Find out more about what a clinical metadata repository should do here >>
A clinical metadata repository is designed to provide a central location for stakeholders to find documents and data related to clinical studies. A clinical metadata repository – also known as a clinical MDR – is intended to improve the management of clinical metadata. Expected outcomes include increased data quality, greater consistency, faster data analysis, and earlier launch of new medicines to market.
