Download Pinnacle 21: The Ultimate Guide for Clinical Data Compliance
If you are involved in clinical data management, analysis, or submission, you know how important it is to ensure that your data is compliant with the standards and requirements of regulatory agencies such as FDA and PMDA. You also know how challenging and time-consuming it can be to validate, transform, and document your data according to the CDISC standards. That's why you need Pinnacle 21, the gold standard for clinical data compliance.
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What is Pinnacle 21 and why do you need it?
Pinnacle 21 is a suite of software solutions that help you prepare your clinical data for submission to regulatory agencies. It automates the process of validating, converting, and generating your data files, metadata, and documentation according to the CDISC standards. It also provides you with feedback and guidance on how to resolve any issues or errors that may arise during the validation process.
Pinnacle 21 offers two main products: Pinnacle 21 Community and Pinnacle 21 Enterprise. Depending on your needs and budget, you can choose the one that suits you best.
Pinnacle 21 Community: A free and open source tool for data validation
Pinnacle 21 Community is a free and open source software that you can download from the official website of Pinnacle 21. It includes four modules: Validator, Define.xml Generator, Data Converter, and ClinicalTrials.gov Miner. You can use these modules to validate your data against the latest set of standard validation configurations, generate Define.xml files, convert your data formats, and mine data from ClinicalTrials.gov.
Pinnacle 21 Community is compatible with Windows and Mac OS X operating systems. It also supports all CDISC terminologies starting from version 3.0. You can use it to validate your data for FDA and PMDA submissions.
Pinnacle 21 Enterprise: A premium and secure solution for data submission
Pinnacle 21 Enterprise is a premium and secure software that you can purchase from Pinnacle 21. It includes all the features of Pinnacle 21 Community, plus some additional benefits such as:
Access to a web-based interface that allows you to manage your projects, users, roles, permissions, and workflows
Integration with your existing data standards, systems, and processes
Customization of your validation configurations, rules, reports, and outputs
Enhanced performance, scalability, security, and reliability
Dedicated support and training from Pinnacle 21 experts
Pinnacle 21 Enterprise is compatible with Windows, Linux, and Solaris operating systems. It also supports all CDISC terminologies starting from version 2.1.3. You can use it to validate your data for FDA, PMDA, EMA, Health Canada, Swissmedic, ANVISA, NMPA submissions.
How to download and install Pinnacle 21 Community
If you want to try out Pinnacle 21 Community for free, here are the steps you need to follow:
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Step 1: Go to the official website and choose your operating system
Visit the and scroll down to the section where you can choose your operating system. You will see three options: Windows, Mac OS X, and Linux. Click on the one that matches your computer.
Step 2: Download the latest release of Pinnacle 21 Community
After clicking on your operating system, you will be redirected to a page where you can download the latest release of Pinnacle 21 Community. You will see a link that says "Download Pinnacle 21 Community". Click on it and save the file to your preferred location.
Step 3: Install the software and follow the instructions
Once the download is complete, locate the file and double-click on it to start the installation process. You will see a window that asks you to agree to the terms and conditions of Pinnacle 21. Read them carefully and click on "I Agree" if you accept them. Then, follow the instructions on the screen to complete the installation. You may need to restart your computer after the installation is done.
How to use Pinnacle 21 Community for data validation
Now that you have installed Pinnacle 21 Community, you can start using it for data validation. Here are the steps you need to follow:
Step 1: Select your validation configuration and input files
Launch Pinnacle 21 Community and click on the "Validator" module. You will see a window that allows you to select your validation configuration and input files. A validation configuration is a set of rules and checks that Pinnacle 21 uses to validate your data. You can choose from the predefined configurations that are available for different regulatory agencies and CDISC standards, or you can create your own custom configuration.
To select your validation configuration, click on the drop-down menu next to "Validation Configuration" and choose the one that matches your submission requirements. For example, if you are submitting data to FDA using SDTM version 1.7, you can choose "FDA (SDTMIG v1.7)" as your validation configuration.
To select your input files, click on the "Browse" button next to "Input Files" and navigate to the folder where you have stored your data files. You can select multiple files at once by holding down the Ctrl key while clicking on them. Your input files should be in SAS XPORT format (.xpt) or SAS dataset format (.sas7bdat). You can also select a folder that contains all your input files by clicking on the "Select Folder" button.
Step 2: Run the validation and review the results
After selecting your validation configuration and input files, click on the "Run Validation" button at the bottom of the window. Pinnacle 21 will start validating your data and display the progress and status of the validation in a new window. You will see a green check mark next to each file that passes the validation, a yellow warning sign next to each file that has warnings, and a red error sign next to each file that has errors.
To review the results of the validation, click on any file name in the window. You will see a detailed report that shows all the issues and messages that Pinnacle 21 found in your data. You can filter, sort, search, export, and print the report as needed. You can also click on any issue or message to see more information about it, such as its description, severity, location, source, rule ID, and suggested resolution.
Step 3: Generate Define.xml and other output files
After reviewing the results of the validation, you can generate Define.xml and other output files that are required for your submission. Define.xml is an XML file that describes the structure, content, and metadata of your data files. It is an essential part of any CDISC submission.
To generate Define.xml and other output files, click on the "Generate Outputs" button at the bottom of the window. You will see a new window that allows you to select the output files that you want to generate. You can choose from the following options:
Define.xml: This is the main output file that describes your data files and metadata. You can choose the version, style, and encoding of your Define.xml file. You can also add comments, annotations, and references to your Define.xml file.
Reviewers Guide: This is an optional output file that provides additional information and guidance for the reviewers of your submission. You can choose the template, format, and content of your Reviewers Guide file.
Data Definition Table: This is an optional output file that provides a summary of your data files and variables. You can choose the format and content of your Data Definition Table file.
Data Issues Report: This is an optional output file that provides a summary of the issues and messages that Pinnacle 21 found in your data. You can choose the format and content of your Data Issues Report file.
After selecting the output files that you want to generate, click on the "Generate" button at the bottom of the window. Pinnacle 21 will start generating your output files and display the progress and status of the generation in a new window. You will see a green check mark next to each output file that is successfully generated, and a red error sign next to each output file that fails to generate.
To view or save your output files, click on any output file name in the window. You will see a preview of the output file in a new window. You can also right-click on any output file name and choose "Save As" to save the output file to your preferred location.
How to upgrade to Pinnacle 21 Enterprise for data submission
If you want to upgrade to Pinnacle 21 Enterprise for data submission, here are the steps you need to follow:
Benefits of Pinnacle 21 Enterprise over Pinnacle 21 Community
Pinnacle 21 Enterprise offers several benefits over Pinnacle 21 Community, such as:
Access to a web-based interface that allows you to manage your projects, users, roles, permissions, and workflows
Integration with your existing data standards, systems, and processes
Customization of your validation configurations, rules, reports, and outputs
Enhanced performance, scalability, security, and reliability
Dedicated support and training from Pinnacle 21 experts
With Pinnacle 21 Enterprise, you can streamline your data compliance process and ensure that your data meets the highest quality standards for submission.
How to request a demo and a quote from Pinnacle 21
If you are interested in Pinnacle 21 Enterprise, you can request a demo and a quote from Pinnacle 21 by filling out a simple form on their website. Here are the steps you need to follow:
Visit the and scroll down to the section where you can request a demo and a quote.
Fill out the form with your name, email address, phone number, company name, job title, country, industry, and message.
Click on the "Submit" button at the bottom of the form.
Wait for a response from Pinnacle 21 within one business day.
Pinnacle 21 will contact you via email or phone to schedule a demo and provide you with a quote for Pinnacle 21 Enterprise. You can ask any questions or clarifications that you may have during the demo or after receiving the quote.
How to install and use Pinnacle 21 Enterprise with your data standards
If you decide to purchase Pinnacle 21 Enterprise, you will receive an email from Pinnacle 21 with instructions on how to install and use it with your data standards. Here are the steps you need to follow:
Download the installation package from the link provided in the email.
Extract the installation package to a folder on your computer.
Run the installer and follow the instructions on the screen.
Login to Pinnacle 21 Enterprise using your username and password provided in the email.
Create or import your data standards using the "Data Standards Manager" module.
Create or import your validation configurations using the "Validation Configuration Manager" module.
Create or import your projects using the "Project Manager" module.
Select your project and run the validation using the "Validator" module.
Review the results and generate the outputs using the "Output Generator" module.
Submit your data and outputs to the regulatory agency using the "Submission Manager" module.
Pinnacle 21 Enterprise will guide you through the entire data compliance process and help you submit your data with confidence and ease.
Conclusion and FAQs
Pinnacle 21 is a suite of software solutions that help you prepare your clinical data for submission to regulatory agencies. It automates the process of validating, converting, and generating your data files, metadata, and documentation according to the CDISC standards. It also provides you with feedback and guidance on how to resolve any issues or errors that may arise during the validation process.
Pinnacle 21 offers two main products: Pinnacle 21 Community and Pinnacle 21 Enterprise. Pinnacle 21 Community is a free and open source software that you can download from the official website of Pinnacle 21. Pinnacle 21 Enterprise is a premium and secure software that you can purchase from Pinnacle 21. Depending on your needs and budget, you can choose the one that suits you best.
In this article, we have explained how to download and install Pinnacle 21 Community, how to use it for data validation, and how to upgrade to Pinnacle 21 Enterprise for data submission. We hope that this article has helped you understand how to use Pinnacle 21 for your data compliance needs.
If you have any questions or comments, please feel free to contact us or leave a comment below. We would love to hear from you!
Here are some FAQs that you may find useful:
Q: What are the system requirements for Pinnacle 21 Community?
A: Pinnacle 21 Community requires a computer with Windows or Mac OS X operating system, Java Runtime Environment (JRE) version 8 or higher, at least 4 GB of RAM, and at least 500 MB of free disk space.
Q: How can I update Pinnacle 21 Community to the latest version?
A: You can update Pinnacle 21 Community by downloading the latest release from the official website of Pinnacle 21 and installing it over your existing installation. You do not need to uninstall the previous version before installing the new one.
Q: How can I get support for Pinnacle 21 Community?
A: You can get support for Pinnacle 21 Community by visiting the , where you can find user guides, tutorials, videos, and FAQs on how to use Pinnacle 21 Community.
Q: What are the differences between Pinnacle 21 Community and Pinnacle 21 Enterprise?
A: The main differences between Pinnacle 21 Community and Pinnacle 21 Enterprise are:
Pinnacle 21 Community is a free and open source software that you can download from the official website of Pinnacle 21. Pinnacle 21 Enterprise is a premium and secure software that you can purchase from Pinnacle 21.
Pinnacle 21 Community has a desktop-based interface that allows you to validate your data locally on your computer. Pinnacle 21 Enterprise has a web-based interface that allows you to manage your projects, users, roles, permissions, and workflows online on a server.
Pinnacle 21 Community uses predefined validation configurations that are available for different regulatory agencies and CDISC standards. Pinnacle 21 Enterprise allows you to customize your validation configurations, rules, reports, and outputs according to your specific needs.
Pinnacle 21 Community supports all CDISC terminologies starting from version 3.0. Pinnacle 21 Enterprise supports all CDISC terminologies starting from version 2.1.3.
Pinnacle 21 Community supports data validation for FDA and PMDA submissions. Pinnacle 21 Enterprise supports data validation for FDA, PMDA, EMA, Health Canada, Swissmedic, ANVISA, NMPA submissions.
Pinnacle 21 Community does not provide any support or training from Pinnacle 21 experts. Pinnacle 21 Enterprise provides dedicated support and training from Pinnacle 21 experts.
Q: How much does Pinnacle 21 Enterprise cost?
A: The cost of Pinnacle 21 Enterprise depends on various factors such as the number of users, the number of projects, the duration of the license, and the level of support and training required. To get an accurate quote for Pinnacle 21 Enterprise, you need to request a demo and a quote from Pinnacle 21 by filling out a form on their website.
Q: How can I get support for Pinnacle 21 Enterprise?
A: You can get support for Pinnacle 21 Enterprise by contacting the Pinnacle 21 support team via email, phone, or chat. You can also access the , where you can find user guides, tutorials, videos, and FAQs on how to use Pinnacle 21 Enterprise.
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