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Pinnacle 21®

Pinnacle 21 Enterprise: De-risk and expedite submissions by ensuring clinical data compliance

Pinnacle 21 by Certara
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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.

P21 Clinical Data Validation

Why do clinical data validation in Pinnacle 21 Enterprise?

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.

Fix issues upfront

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.

Align with regulators

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.

Validate your way

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.

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. ​

Pinnacle 21 Enterprise Software Suite - solutions table

Using Community? See what you're missing in Pinnacle 21 Enterprise

Why 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. 

Clinical Data Validation - CDISC

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.

Pinnacle 21 Enterprise validation checks
Review of data for consistency, completeness and scientific integrity
Submission-ready data including SDTM, ADaM, Define.XML and Study Data Reviewers’ Guides
TLF programming

Related resources

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Fact Sheet

Pinnacle 21 Enterprise: Dataset Validation & Submission Readiness

Explore how Pinnacle 21 Enterprise simplifies dataset validation, enhances compliance, and prepares you for regulatory submissions.
Read more
2 / 3
Case Study

How Chinese CRO, Zhejiang Longcharm Biomedical Technology Uses Pinnacle 21 Enterprise to Optimize Sponsors’ Non-clinical and Clinical Regulatory Affairs

Learn how one CRO uses Pinnacle 21 to optimize sponsors’ clinical regulatory affairs, saving time and improving stakeholder communication.
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Guide

Define.xml Submission Checklist

Learn how to create a compliant Define.xml submission package with our Define.xml submission checklist, and best practice do’s and don’ts.
Read more

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 data validation process. Schedule a demo today to see the platform in action and learn how it can help you achieve submission success.

Ensure compliance with regulatory standards.
Identify and resolve issues early in the process.
Accelerate submission timelines and reduce risks.

Book a free demo

Make an inquiry about Pinnacle products

Not ready for a demo?

Fill out this form to make an inquiry about the Pinnacle 21 product portfolio, or to discuss your requirements with our team, and we’ll get back to you right away.

FAQs

What is data validation in clinical data management?

Clinical data validation is the process of verifying clinical trial data, in order to ensure submission of high quality, accurate clinical trial data. Essentially, data validation includes making sure that data is complete, consistent, and accurate.

How do you validate clinical data?

Clinical data validation varies according to different factors, such as the type of data collected, and the regulatory requirements it is subject to. A typical data validation process includes checking data against the rules and criteria defined at the outset. Errors, inconsistencies, or gaps would be identified as part of the validation process, and solutions determined accordingly.

What are clinical data validation rules?

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.