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
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Have your define.xml files ready to submit faster
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Faster define-xml submission deliverables
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.
Visualize define.xml
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
Any errors or invalid entries are instantly highlighted in real-time. 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!
Pinnacle 21 Enterprise Software Suite
With Pinnacle 21 Enterprise as your foundation, add additional functionality according to your requirements. Get in touch to find out more about adding additional modules to your Enterprise platform.
How you’re better off with 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!
Maximize resources
With our code-free define tool, you don’t need to be an expert programmer to create high quality submission deliverables. Automation replaces manual work, meaning costly programming resources can be diverted to higher value projects.
Speed drugs to market
With faster, accurate define creation and no end-of-study delays, clinical trials can be submitted earlier compared with traditional, manual methods. As a result, sponsors can bring new approved drugs to market sooner, and start realizing profits far earlier.
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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 validation checks
Review of data for consistency, completeness and scientific integrity
TLF programming
Why 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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With Pinnacle 21, your data is secure
Certara holds ISO 27001 certification for Certara’s Information Security Management System (ISMS). We have implemented robust security controls, undergone rigorous risk assessments, and continuously strive for improvement. Pinnacle 21 ensures full compliance with global data protection standards, offering peace of mind for sensitive analysis.
Learn more in our Trust Center
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.
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FAQs
What is 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.
What is the Define-XML standard?
The Define-XML standard is based on the CDISC Operational Data Model (ODM) XML schema. 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.