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Pinnacle 21 Enterprise: 通过确保临床数据的合规性，降低风险并加快递交速度

Ensure your clinical data is ‘fit to submit'

Certara’s Pinnacle 21 Enterprise (P21E) software revolutionizes clinical data validation by ensuring compliance with SDTM, ADaM, and SEND datasets.

Designed to align with regulatory standards, P21E empowers sponsors, CROs, and academia to deliver accurate, compliant clinical trial data. By identifying errors and inconsistencies early, P21E mitigates risks, accelerates submissions, and ensures data integrity throughout the study lifecycle.

Use the same platform as the FDA and PMDA to review your submission quality.

预约演示

为什么要在 Pinnacle 21 Enterprise 中进行临床数据验证？

Pinnacle 21 Enterprise provides a robust solution for clinical data validation, offering unmatched oversight and control. With its advanced dashboards, data fitness scoring, and in-stream validation, P21E ensures that your clinical trial data meets regulatory requirements. This platform simplifies collaboration, enhances data quality, and accelerates submission readiness.

预先解决问题

P21E’s clinical data validation software identifies errors and non-compliance issues before submission. Easily review datasets against rejection criteria, so you can fix issues in advance.

Monitor submission readiness

Easily monitor submission readiness with our data fitness scores. See which issues to fix as a priority, knowing the impact on your score. Now you can focus time and effort on fixing the right issues. Even use projected scoring to anticipate future results, allowing you to intervene early in at-risk projects.

Gain oversight and control

Monitor submission progress and have visibility of all team activity. No more siloed working! Track before and after changes between validation runs. And with 20+ pre-built reports, you’ll have KPIs and metrics to deep dive into data analytics, identifying trends or inconsistencies across trials.

与监管机构保持一致

The platform checks for compliance against CDISC standards, controlled terminology, and even dictionaries such as MedDRA and WHODrug. It also verifies conformance against the specific rules of each regulatory agency, with insights and tips to stay compliant.

Validate in-stream

Continuous validation in clinical data management means in-study data validation checks – rather than waiting for submission, which can cause delays. Our tool supports SDTM validation rules, ADaM validation rules, Define-XML validation rules, and SEND validation rules.

以您的方式验证

You can upload any organizational standards, terminology, and business rules into our clinical trial validator software, to verify CDISC compliance and check for any issues. That way, data can be validated according to your internal setup.

Compare P21 Community to P21 Enterprise

如何更好地使用 Pinnacle 21 Enterprise

降低失败风险

Without accurate, compliant trial data, a lot of costly rework is needed. And this delays drugs getting to market. It could even risk submission failure! With P21E, validation and conformance checks keep you compliant throughout. Being able to preview data readiness before submission – in the same tool used by regulators – also provides reassurance that you’re not risking non-compliance.

在指导下获得批准

利用我们有用的仪表板和数据健康指标评分工具，轻松监控数据完整性并跟踪提交准备进度。查看哪些是需要优先解决的问题，以及这些问题对您的评分有何影响。您还将获得我们提交专家在页面上显示的指导和技巧提示。

这是 FDA 和 PMDA 用于审核您临床试验提交资料质量的唯一平台。

Accelerate the review process

With in-stream validation and detailed submission guidance, the review process becomes far more efficient. Now you’ll have all the tools you need to accelerate the review process, and expedite submissions.

为什么选择 Certara

Certara is your trusted provider for advancing drug development, with innovative solutions that ensure compliance, accelerate timelines, and improve outcomes.

The Pinnacle 21 Enterprise platform assures that your clinical data is ‘fit to submit’. It’s the same platform used by the FDA and PMDA to review submission quality – which is testament to our track record as a trusted partner in the world of clinical data.

Our technical expertise is backed back years of CDISC knowledge and data standards experience. This makes us well placed to deliver industry-leading professional services and support to our customers.

了解更多关于 Certara 软件和服务介绍

Technical support with validation

Need some support with clinical data validation? With decades of experience helping thousands of clients meet clinical data compliance requirements, our technical experts can ensure the quality of your regulatory submission.

了解更多信息

Pinnacle 21 Enterprise 验证检查

审查数据的一致性、完整性及科学完整性

符合提交要求的数据，包括 SDTM、ADaM、Define.XML 及研究数据 Reviewers’ Guides

TLF 编程

您的数据是安全的

Your data is safe with Pinnacle 21 Enterprise. Our platform is ISO-certified, ensuring the highest standards of data security and compliance.

Book a free no-obligation demo

Discover how Pinnacle 21 Enterprise can transform your clinical data validation process. Schedule a demo today to see the platform in action and learn how it can help you achieve submission success.

确保符合监管标准

Identify and resolve issues early in the process.

Accelerate submission timelines and reduce risks.

Book a free demo

常见问题解答

什么是临床数据管理中的数据验证？

临床数据验证是对临床试验数据进行核实的过程，以确保提交高质量、准确的临床试验数据。从本质上讲，数据验证包括确保数据的完整性、一致性和准确性。

如何对临床数据进行验证？

临床数据验证因不同因素而异，如收集的数据类型和所需遵守的监管要求。典型的数据验证流程包括根据一开始定义的规则和标准检查数据。作为验证过程的一部分，将找出错误、不一致或差距，并确定相应的解决方案。

什么是临床数据验证规则？

Clinical data validation rules are a set of criteria that the data is required to meet in order to be correct, complete and consistent. Validation rules specify the acceptable values, formats, relationships, and conditions that data must correspond with.

Pinnacle 21

Pinnacle 21 Enterprise: 通过确保临床数据的合规性，降低风险并加快递交速度

Ensure your clinical data is ‘fit to submit'