Define.xml is a critical component of regulatory submissions for SDTM, SEND, and ADaM datasets. However, creating these files manually is time-consuming and prone to errors. Pinnacle 21 Enterprise simplifies this process by automating the creation of define.xml files, dataset metadata, annotated CRFs, and Reviewer’s Guides. With built-in validation and intuitive tools, you can ensure your submissions are accurate, compliant, and ready for approval.
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Define-XML: Automate Your Define.xml Files with Pinnacle 21
Learn more about automating Define-XML
Effortlessly create define.xml files for SDTM, SEND, and ADaM datasets
Pinnacle 21 Enterprise’s define-xml tool is designed to streamline your submission process, ensuring compliance and efficiency. By embedding the Define-XML standard into dataset design, the platform reduces manual effort and eliminates costly errors.
Automate define.xml
Automatically create define.xml files for SDTM, SEND, and ADaM. Simply edit and manage files like a spreadsheet! You can also import spreadsheets to instantly convert to XML format.
Accurately predict define.xml
When you design forms for an EDC in P21E, the platform accurately predicts the define.xml for the datasets that would be created – based on your form design. That way you’ll have submission deliverables from study startup.
Define.xml 可视化
Preview your define.xml metadata in PDF, or using the published CDISC stylesheet. This includes full definition of the define, page links to annotated CRFs, and hyperlinks to submission datasets.
Ensure compliance with real-time validation
任何错误或无效条目都会立即实时高亮显示。 So validation is baked in from the start, and you can be confident your define.xml is flawless! Even import existing spreadsheets, SDTM or ADaM datasets into the platform and validate in real-time. All that’s left is to extract your final define.xml file at the click of a button!
Manage version control
You can update and version your Define.xml files in P21E, allowing complete visibility and change control. Assess changes over time by comparing studies, study versions, or comparing content with standards.
Generate Reviewer’s Guides
Submit clear, complete data and easily share context and pre-empt questions in P21E. Our tool automates content aggregation and formatting, allowing further time savings. Then it’s just one click to generate your submission ready Reviewer’s Guide!
如何更好地使用 Pinnacle 21 Enterprise
Avoid costly study delays
Now you can avoid costly end-of-study delays, and put your new drug in the best position for approval. Our automation tools and in-stream validation help you produce accurate define files from the start, ensuring compliant submission deliverables!
优化资源配置
使用我们的无代码 Define 工具，无需成为编程专家，也能轻松创建高质量的提交成果。Automation replaces manual work, meaning costly programming resources can be diverted to higher value projects.
加快药品上市速度
相较于传统的手工方法，通过更快速、准确的 Define 文件创建，以及避免研究结束时的延误，临床试验的提交时间可大幅提前。因此，申办方能更早地将新获批药物推向市场，并提前开始获得利润。
相关产品
8 best practice steps and 10 mistakes to avoid when creating a compliant define-xml submission
Technical support with define.xml
Got an urgent deadline or need a hand producing your define.xml submission package? Our experienced technical experts are here to help prepare your submission ready data, ensuring quality and compliance.
Submission-ready data including define.xml, SDTM, ADaM, and Study Data Reviewers’ Guides
Pinnacle 21 Enterprise 验证检查
审查数据的一致性、完整性及科学完整性
TLF 编程
为什么选择 Certara
Certara empowers drug development companies and professionals with innovative solutions that help ensure compliance, accelerate timelines, and enhance outcomes.
Trusted by the FDA and PMDA, Pinnacle 21 Enterprise instills confidence that your clinical data is submission-ready. With unmatched CDISC expertise and years of experience in clinical data standards, we deliver industry-leading professional services and support to customers across the globe.
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您的数据是安全的
Your data is safe with Define-XML. Pinnacle 21 Enterprise adheres to the highest security standards, ensuring your clinical trial data is protected.
Book a free no-obligation demo
Discover how Pinnacle 21 Enterprise can transform your clinical trial submission process. Book a no-obligation demo today to explore the benefits of automated define.xml creation.
Automate define.xml creation for SDTM, SEND, and ADaM datasets.
Ensure compliance with built-in validation tools.
Save time and resources with intuitive, code-free solutions.
常见问题解答
什么是 Define.XML?
Define.xml is the metadata file that describes the content and formatting of clinical trial submission datasets. It is a required component for regulatory submissions.
什么是 Define-XML 标准？
Define-XML 标准基于 CDISC 运行数据模型 (Operational Data Model, ODM) XML 模式。It ensures vendor-neutral and platform-independent data exchange.
Why is define.xml important?
Define.xml ensures that regulatory agencies can understand and review your clinical trial data accurately and efficiently.
