Managing clinical data issues across decentralized teams can be a daunting and time-consuming task. Pinnacle 21 Enterprise (P21E) revolutionizes this process by providing a single, collaborative platform for issue resolution.
With P21E, you can assess, triage, and resolve clinical data issues efficiently, while maintaining a clear audit trail for compliance. The platform ensures you always work with the most up-to-date information, helping you track submission readiness in real-time.
Pinnacle 21 Enterprise simplifies issue management by providing detailed explanations, actionable insights, and expert guidance. The platform’s innovative features, such as the data fitness score and customizable specifications, empower teams to improve data quality and regulatory compliance.
The frustration of spending hours searching for answers in long email chains or local spreadsheets is finally over! With P21E, you can identify, communicate, and resolve clinical data issues together in one central, collaborative platform. Now you’ll have a ‘single source of truth’ that’s always up to date.
Get detailed, actionable information about every issue, including specific rule violations and their impact on regulatory compliance. Supplement these details with your own custom details, such as fix tips, company-specific tags, and issue explanations.
Each data package is assigned a ‘fitness score’ between 0-100. This provides a clear predicted measure of how close you are to submission readiness, based on the number and severity of reject issues. P21E 会根据对数据健康指标评分的影响，告诉你哪些问题需要优先解决。 You can also track key trends and KPIs across your portfolio.
Streamline communication and issue resolution with all stakeholders working off the latest information in one central platform.
With our expert guidance you can leverage proven ‘Fix Tips’ and company-specific advice to resolve issues more quickly and confidently..Knowing which issues to fix as a priority and how that impacts your ‘data fitness score’ means you can focus on what counts and accelerate submission readiness.
P21E dashboards provide enterprise-wise oversight, allowing you to track team activity and understand key performance metrics across projects. With the relevant information at your fingertips, you’ll be able to make informed decisions to optimize resources and streamline processes.
The Pinnacle 21 Enterprise platform ensures that your clinical trial data meets the required regulatory standards for successful submission. Trusted for clinical data validation by both the FDA and PMDA, our platform demonstrates a unique level of reliability when it comes to clinical data review.
With decades of experience in clinical data standards, including CDISC, our team is well placed to provide industry-leading professional services and hands-on support to your organization.
Your data is safe with Pinnacle 21 Enterprise. Our platform complies with the highest industry standards to ensure your data’s security and integrity.
Discover how Pinnacle 21 Enterprise can transform your clinical data management process. Book a no-obligation demo to see the platform in action.
Pinnacle 21 Enterprise is a centralized platform for managing clinical data issues, improving compliance, and tracking submission readiness.
The data fitness score provides a measure of submission readiness, helping you prioritize issues based on their impact.
Yes, Pinnacle 21 Enterprise allows for customizable specifications, rules, and issue details to align with your organization’s requirements.
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