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Get compliant datasets faster with our SDTM mapping specifications software

Leverage our SDTM mapping tool to create specs with greater speed & compliance

Pinnacle 21’s SDTM mapping tool helps you quickly and easily map source variables to target SDTM formats – avoiding complex, time consuming and error prone manual processes.

Reuse existing mapping specs from a previous study or established standard to reduce manual rework. Then perform any required re-mappings as identified in the platform. Our mapping algorithm helps with any complex mappings. And errors are identified in-stream, enabling upfront issue resolution.

Now you can produce human-readable or machine-readable SDTM mappings with increased efficiency and compliance!

预约演示

Why use an SDTM mapping tool?

The Pinnacle 21 SDTM mapping tool empowers you to ditch the spreadsheets and leave time consuming manual processes behind! Now you can create CDISC compliant SDTM mapping specifications quickly and accurately – accelerating SDTM dataset creation, and speeding time to submission!

Faster submissions

When you create SDTM aligned mapping specifications at the start of your study, alongside CRF design, quality and compliance is built in from the outset. As a result, your data is already in the required regulatory format, and has been validated throughout. Now you can save time and avoid costly delays at the end – maximizing submission readiness from the very start!

Improve quality & compliance

Reusing standardized SDTM mapping specifications from your library of approved studies and standards reduces the amount of error prone manual work needed. In-stream validation and compliance checks ensure any errors or inconsistencies are instantly flagged. And having a built-in chat feature allows teams to discuss and resolve issues in real-time, maintaining compliance throughout.

优化资源配置

You don’t need your finest expert programming resources to create high quality specs with our SDTM specification management tool. Automation replaces time consuming, repetitive manual work. As a result, valuable programming resources can be be dedicated to more complex processes, and efficiencies made as costly resources are maximized where they’re needed most.

Best practice guide for mapping to SDTM

How you’re better off with Pinnacle 21 Enterprise SDTM specification management tool

Faster study specifications

With a library of standardized SDTM mapping specifications at your disposal, simply reuse an existing validated standard or study spec. Rather than starting from new for every study, all that’s needed is to identify any remapping needs – resulting in much quicker and easier mapping specifications, and in turn, much faster study design.

Full traceability & governance

Automatically track changes and maintain complete version visibility and control across the entire study lifecycle. Even define your own approvals workflow in the platform, ensuring a controlled and consistent approach to change management.

Quicker issue resolution

With chat functionality in our SDTM mapping tool, teams can easily collaborate in one central platform. There’s no more managing issues in lengthy email chains and spreadsheets, which are hard to keep track of. Now issues can be resolved much more efficiently, in real-time.

为什么选择 Certara？

Built on a legacy of excellence in CDISC standards and clinical data compliance, Certara is the perfect partner for both innovative technology and industry-leading technical support.

Pinnacle 21 Enterprise empowers you with the same platform trusted by the FDA and PMDA to assess submission quality – ensuring a seamless, compliant clinical trial submission process. With Certara as your partner, you gain not just innovative technology but also unparalleled support to transform how you navigate regulatory pathways.

了解更多关于 Certara 软件和服务介绍

Learn everything you need to know in our best practice guide to SDTM mapping

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SDTM mapping resources

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博客

关于 SDTM 您需要了解的一切

从 SDTM 实施指南到 SDTM 数据集创建的分步流程，了解有关 CDISC SDTM 的所有信息。

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指南

CDISC SDTM 映射最佳实践指南

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博客

The SDTM Mapping Process Simplified

SDTM mapping can be one of the most challenging programming problems in a clinical trial build. It involves mapping datasets from a non-CDISC structure, for example the structure used in...

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指南

A Quick Guide to SDTM Dataset Creation

Our free quick guide can help you better understand SDTM datasets and get started quick with SDTM dataset creation.

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案例研究

一所大学是如何克服实际操作和文化挑战来实施 CDISC 合规性的

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您的数据是安全的

Your data is safe with Pinnacle 21 Clinical Metadata Repository. Certara is ISO-certified, ensuring the highest level of data security and compliance for your clinical study submissions.

Accelerate SDTM specifications with Pinnacle 21

Schedule a consultation to see how Pinnacle 21’s SDTM specification management tool helps you get from source data to SDTM target much quicker, and with less manual effort!

掌握数据标准化与验证

体验提交效率的新维度

协调多源数据

常见问题解答

什么是临床试验中的 SDTM？

SDTM 指研究数据制表模型（Study Data Tabulation Model）。它是制药和临床研究行业所需的标准化格式，用于组织人体临床试验中的患者数据并将其提交给监管机构，如美国食品药品管理局（FDA）。2004 年，SDTM 被宣布为临床研究数据提交的必备标准格式。根据 SDTM 结构证明数据可确保一致性，并使临床研究中的分析更高效、更透明。

什么是 SDTM 数据集？

SDTM 数据集，即研究数据制表模型数据集，是按照 SDTM 标准制作的数据表。SDTM is the required format for tabulation data submission to the FDA and PMDA. SDTM 数据集包含与临床试验患者有关的信息，包括人口统计学、治疗、不良反应等。Find out all you need to know about SDTM in our helpful blog >>

How do you create SDTM mapping specifications?

SDTM specifications describe how raw data is to be converted. 生物统计程序员使用它们将数据转换为 SDTM 格式。开发 SDTM 数据集的过程首先要从 CRFs 和原始数据中确定所需的 SDTM 域开始。然后，将原始数据集变量（Non-CDISC 结构）映射到相关的 CDISC SDTM 域变量。这样，您就能知道哪个原始数据集能为 SDTM 域提供数据。最后，列出每个 SDTM 领域的所有变量，并说明应如何对其进行编程。Want to know more? Read our helpful best practice guide to CDISC SDTM Mapping >>

Pinnacle 21^®

Get compliant datasets faster with our SDTM mapping specifications software

Leverage our SDTM mapping tool to create specs with greater speed & compliance