That's where Pinnacle 21 comes in. Pinnacle 21 is a software platform that helps you streamline and automate the process of clinical data standardization. It enables you to validate, review, and transform your data according to the latest industry standards and best practices.
In this article, we will explain what Pinnacle 21 is, how it works, and why you should use it for your clinical data standardization needs.
What is Pinnacle 21 and How Does It Work?
Pinnacle 21 is a software platform that helps you standardize your clinical data for submission to regulatory agencies such as the FDA and the PMDA. It supports various data formats such as CDISC SDTM, ADaM, Define-XML, and SEND.
Pinnacle 21 works by performing a comprehensive validation of your data against the industry standards and guidelines. It identifies any errors, warnings, or issues that may affect the quality or compliance of your data. It also provides you with detailed reports and dashboards that help you review and resolve any problems.
Pinnacle 21 also helps you transform your data into the required format and structure for submission. It allows you to map your source data to the target standards using a graphical user interface or a scripting language. It also generates the necessary metadata and documentation for your submission package.
Why Should You Use Pinnacle 21 for Your Clinical Data Standardization Needs?
Pinnacle 21 offers many benefits for your clinical data standardization needs. Here are some of them:
It saves you time and resources by automating and simplifying the process of data validation and transformation.
It improves the quality and compliance of your data by ensuring that it meets the latest industry standards and best practices.
It reduces the risk of rejection or delay by regulatory agencies by helping you avoid any potential issues or discrepancies in your data.
It enhances the collaboration and communication among your team members and stakeholders by providing a common platform and language for data standardization.
It supports the continuous improvement and innovation of your data standardization process by providing you with updates, feedback, and guidance from the industry experts and community.
Conclusion
Pinnacle 21 is a software platform that helps you standardize your clinical data for submission to regulatory agencies. It validates, reviews, and transforms your data according to the industry standards and best practices. It also provides you with reports, dashboards, metadata, and documentation for your submission package.
Pinnacle 21 is the ultimate solution for your clinical data standardization needs. It saves you time and resources, improves the quality and compliance of your data, reduces the risk of rejection or delay by regulatory agencies, enhances the collaboration and communication among your team members and stakeholders, and supports the continuous improvement and innovation of your data standardization process.
If you want to learn more about Pinnacle 21 or request a demo, visit their website at https://www.pinnacle21.com/.
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