With Pinnacle 21 Enterprise clinical data validation software

Provision of accurate, compliant clinical trial data is essential for submission to regulatory agencies like the FDA and PMDA. Without high quality data, you risk costly delays – and worst case scenario, a failed submission.   

But with Pinnacle 21 Enterprise (P21E), you can be confident your study data is in the best possible shape – before submission. In-stream clinical data validation and conformance checks highlight issues, so they can be fixed accordingly in real-time. And our dashboards show ‘data fitness’ results pre-submission. So you’ll know when your data is good enough. It’s the same platform used by the FDA and PMDA to review submission quality. So if you’re using P21E, you’re literally viewing through the eyes of the regulators!

Use the same platform as the FDA & PMDA to check your submission quality!

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. That way, you’ll mitigate the risk of non-conformance, and accelerate the review process for your trial.

Prioritize fixes

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! You can even use projected scoring to anticipate future results, allowing you to intervene early in at-risk projects.

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 in and 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.

Continuous compliance

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.

Mitigate the risk of failure

Without accurate, compliant trial data, a lot of costly rework is needed – which delays drugs getting to market. It could even risk submission failure. With P21E, you can have confidence in your data integrity! Validation and conformance checks keep you compliant throughout. And being able to preview data readiness before submission – in the same tool used by regulators – gives 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.

Speed drugs to market

Being able to identify and fix issues before submission really shortens the review process. In-stream validation and issue resolution provide all the tools to speed submission readiness. So with our clinical data validation software, you’ll have the opportunity to get new drugs approved and launched earlier. Now you can beat the competition and maximize profits by launching earlier!

Ease regulatory submission prep

Validation in clinical data management ensures that your data is robust – from the first data cut. Our validator software helps sponsors, CROs, and academia gain the best possible chance of FDA approval.

The P21E platform enables validation of clinical datasets, such as SDTM, ADaM, and SEND, as well as Define.xml files. Easily analyze data and understand errors or inconsistencies, trends, or reasons for faulty data. Plus, collaboration with stakeholders and external partners, such as CROs, is simplified in one central cloud platform.