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Pinnacle 21®

Resolve issues more efficiently with our clinical data issue management software

Pinnacle 21 by Certara
デモの相談

Manage clinical data issues in a centralized platform

Managing clinical data issues across decentralized teams can be a daunting and time-consuming task. Pinnacle 21 Enterprise (P21E) clinical data issue management software 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 Issue Management screenshot

2,000

Organizations, including the FDA and PMDA, rely on Pinnacle 21 Enterprise

24/25

Out of 25 top pharmaceutical companies use the platform

Why choose Pinnacle 21 Enterprise clinical data issue management software?

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.

Quickly find what you need

The frustration of spending hours searching for answers in long email chains or local spreadsheets is finally over! With P21E clinical data issue management software, 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 issue explanations

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.

Know your submission readiness score

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は、データ適合度スコアに与える影響に基づいて、優先的に修正すべき問題を教えてくれます。 You can also track key trends and KPIs across your portfolio.

Pinnacle 21 Enterprise 統合ソフトウェア

Pinnacle21Enterpriseをベースに、必要な機能を自在に拡張できます。詳細や追加モジュールの導入については、お気軽にお問い合わせください。

Pinnacle 21 Enterprise Software Suite - solutions table

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

How CROs can achieve centralized, scalable issue management

Delivering measurable submission readiness and regulator-aligned validation at scale requires more than basic validation: it demands early issue detection, lifecycle tracking, and continuous conformance checks to minimize rework, prevent delays, and protect sponsor timelines.

Pinnacle 21 Enterprise provides the scale, governance, and multi-study oversight CROs require to deliver timely, compliant deliverables – while improving efficiency and strengthening market position.

サターラが選ばれる理由

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.

関連情報

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製品紹介資料

How to Improve CRO Data Management

Read this fact sheet to learn how Pinnacle 21 Enterprise improves CRO data management and sponsor across the study lifecycle.
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製品紹介資料

Go beyond basic validation: Achieve submission-ready datasets with Pinnacle 21 Enterprise

Pinnacle 21 Enterpriseがどのようにデータセットのバリデーション簡素化、コンプライアンス強化し、規制当局への提出書類準備をサポートするのか説明しています。
詳細を見る
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事例紹介

Validation in clinical data management: MacroGenics® Optimizes Validation and Issue Management with Pinnacle 21® Enterprise

Discover how MacroGenics optimized validation in their clinical data management with our centralized, collaborative Pinnacle 21 platform.
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ブログ

How to Use Fix Tips for Better Clinical Data Issue Management

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ブログ

Platforms for collaboration between sponsors and CROs: 5 ways CROs can scale efficiently while maximizing validation assurance

Platforms for collaboration between sponsors and CROs provide validation assurance & improve sponsor outcomes with guided submission readiness
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ガイド

Define.xml 提出チェックリスト

当社のDefine.xml提出チェックリストとベストプラクティスによる「すべきこと」と「すべきでないこと」を参考に、コンプライアンスに準拠したDefine.xml提出パッケージの作成方法を学んでください。
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データを保護するPinnacle 21

サターラは、情報セキュリティマネジメントシステム（ISMS）について、ISO 27001認証を取得しています。当社は、強固なセキュリティ対策を実施し、厳格なリスク評価を行い、継続的に改善に努めています。Pinnacle21は、世界的なデータ保護基準への完全準拠を保証し、機密性の高い解析を安心して行える環境を提供します。

Trust Centerの詳細はこちら

無料のデモを予約する

Discover how Pinnacle 21 Enterprise clinical data issue management software can transform your clinical data management process. Book a no-obligation demo to see the platform in action.

Centralized issue management for improved efficiency.
Real-time submission readiness tracking with data fitness scores.
Expert guidance and actionable insights for compliance.

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

Pinnacle 21 Enterpriseとは何ですか？

Pinnacle 21 Enterprise is a centralized platform for managing clinical data issues, improving compliance, and tracking submission readiness.

How does the data fitness score work?

The data fitness score provides a measure of submission readiness, helping you prioritize issues based on their impact.

Can I customize the platform for my organization’s needs?

Yes, Pinnacle 21 Enterprise allows for customizable specifications, rules, and issue details to align with your organization’s requirements.

Where can I download Pinnacle 21 community?

If you’re new to Pinnacle 21 and want to get a feel for its basic validation capabilities, you can access Community here: https://help.pinnacle21.certara.net/en/articles/9736610-download-pinnacle-21-community

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