Home / Pinnacle 21 Clinical Data Management & Automation Suite / Validation

Pinnacle 21

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

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.

デモの相談

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.

Compare P21 Community to P21 Enterprise

Pinnacle 21 Enterpriseを導入するメリット

Mitigate the risk of failure

Without accurate, compliant trial data, a lot of costly rework is needed. And this delays drugs getting to market. It could even risk submission failure! With P21E, validation and conformance checks keep you compliant throughout. Being able to preview data readiness before submission – in the same tool used by regulators – also provides reassurance that you’re not risking non-compliance.

Be guided towards approval

Easily monitor data integrity and track progress towards submission readiness with our helpful dashboards and data fitness scoring tool. See which are the priority issues to fix, and how it impacts your score. You’ll even have on-screen guidance and tips from our submission experts.

It’s the only platform used by the FDA and PMDA to review the quality of your clinical trial submissions.

Accelerate the review process

With in-stream validation and detailed submission guidance, the review process becomes far more efficient. Now you’ll have all the tools you need to accelerate the review process, and expedite submissions.

なぜサターラが選ばれるのか

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.

サターラのソフトウェアとサービス紹介：

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.

詳細を表示

Pinnacle 21 Enterprise バリデーションチェック

データの整合性、完全性、科学的完全性の確認

SDTM、ADaM、Define.XML、Study Data Reviewers’ Guidesを含む、申請用データ

TLF プログラミング

データは安全に保護されます

Your data is safe with Pinnacle 21 Enterprise. Our platform is ISO-certified, ensuring the highest standards of data security and compliance.

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

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.

Pinnacle 21

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

Ensure your clinical data is ‘fit to submit'