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Pinnacle 21®

How CROs can deliver faster, submission-ready outcomes for every sponsor

Pinnacle 21 by Certara
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Helping CROs manage submission complexity at scale

As a CRO, your reputation depends on delivering compliant, submission-ready data, on time, every time. Sponsors demand quality, transparency, and regulatory confidence – and effective CRO clinical data management is essential in meeting these expectations.

While Pinnacle 21 Community supports basic validation, it isn’t built for the scale, governance, and multi-study oversight CROs require. Managing multiple sponsors and global submissions goes beyond desktop tools and manual workflows.

Pinnacle 21 Enterprise transforms validation into a centralized, enterprise-grade compliance framework. With Enterprise, CROs can confidently deliver regulatory compliant data faster – while increasing operational efficiency and strengthening competitive advantage.

fix tips in Pinnacle 21 Enterprise

How Enterprise advances CRO clinical data management

Enterprise enables CROs to deliver faster, higher-quality sponsor submissions with measurable confidence. By centralizing validation and governance, CROs reduce risk, improve efficiency, and are empowered to deliver scalable growth across client studies.

Faster sponsor deliverables

Automated validation, centralized issue management, and Define.xml and SDRG generation reduce manual effort and accelerate compliant sponsor submissions.

Submission readiness visibility

Data Fitness Scores provide measurable compliance insight, giving CROs confidence in their clients’ submission readiness, and enabling proactive risk management across portfolios.

Stronger compliance confidence

Validation aligned with the same engine trusted by global regulators ensures sponsor deliverables meet the latest FDA, PMDA, and global agency requirements.

Lower regulatory risk

Continuous in-stream validation identifies conformance issues early – minimizing rework, preventing submission delays, and protecting sponsor timelines.

Greater transparency and auditability

Full validation history, issue lifecycle tracking, and change reports allow CROs to demonstrate complete traceability with documented compliance throughout the study lifecycle.

Scalable multi-study oversight

Portfolio-level dashboards and centralized governance allow CROs to manage validation at scale, and with consistency across studies and sponsors.

Hear how CROs are benefiting from Pinnacle 21 Enterprise

Watch the short video to hear how Summit Analytical are gaining compliance assurance and time savings with Pinnacle 21 Enterprise.

See How Pinnacle 21 Enterprise goes beyond Community for CRO clinical data management

Why Certara

Pinnacle 21 Enterprise facilitates clinical data management for CROs, with scalable validation frameworks that support the delivery of compliant, submission-ready data.

More than technology, our team provides decades of regulatory experience, with deep rooted knowledge of global regulatory and CDISC standards – the same standards regulators use to assess submission quality. This powerful combination strengthens operational performance and reinforces your position as a trusted sponsor partner.

Clinical Data Validation - CDISC

Related resources

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1 / 5
Case Study

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.
Read more
2 / 5
Blog

How does Pinnacle 21 Enterprise differ from the Community version?

This blog gives a detailed step-by-step comparison of the key differences between Pinnacle 21 Enterprise and the standard version, known as Community.
Read more
3 / 5
Fact Sheet

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

Explore how Pinnacle 21 Enterprise simplifies dataset validation, enhances compliance, and prepares you for regulatory submissions.
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4 / 5
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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5 / 5
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 Enterprise, 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

Book a demo of Pinnacle 21 Enterprise to learn how your organization can benefit from reduced risk, increased quality, and guided submission readiness.

Pinnacle 21 Enterprise builds on Community’s core validation capabilities enabling CRO clinical data management at scale:

Advanced validation functionality & alignment with latest validation engines
Enterprise-level governance
Issue tracking, prioritization, and submission readiness guidance
Centralized collaboration and oversight

FAQs

What is the difference between Pinnacle 21 Community and Pinnacle 21 Enterprise for CROs?

Pinnacle 21 Community is a free, desktop-based validation tool (local desktop installation and validation) for basic CDISC conformance checks. Pinnacle 21 Enterprise is a secure,  cloud-based, centrally managed environment. Enterprise provides advanced clinical data  management for CROs – it’s built for managing multiple studies, enabling scalable, centralized validation workflows and submission-ready sponsor deliverables.

How does Pinnacle 21 Enterprise help CROs manage multiple clinical trials?

Pinnacle 21 Enterprise helps CROs manage multiple clinical trials by centralizing validation, facilitating standards governance, and providing issue tracking and documentation workflows in a centralized, secure cloud environment. Portfolio dashboards provide cross-study visibility, enabling consistent validation practices and scalable oversight across sponsor studies.

How does Pinnacle 21 Enterprise reduce regulatory risk for CROs?

Enterprise provides many CRO regulatory compliance tools. In particular, Enterprise reduces regulatory risk by aligning validation with the latest regulatory engines used by agencies such as the FDA and PMDA. Continuous validation, impact prioritization, and Data Fitness Scores also help CROs identify high-risk issues early and prevent costly submission delays.

Does Pinnacle 21 Enterprise automate Define.xml and Reviewer’s Guide creation?

Yes. Pinnacle 21 Enterprise automates around 80% of the Define.xml 2.0 and 2.1 creation process and generates the Study Data Reviewer’s Guide (SDRG). This reduces manual effort, improves consistency, and accelerates submission package preparation.

Why should CROs upgrade from Pinnacle 21 Community to Enterprise?

Pinnacle 21 Enterprise provides CDISC validation software for CROs. CROs should upgrade to Enterprise to gain centralized control, measurable submission readiness indicators, portfolio analytics, automated documentation, and enterprise-grade compliance governance. Unlike Community, Enterprise is built to support multi-study operations and strengthen clinical data management for CROs. Read this blog to learn more about transitioning to Enterprise: https://www.certara.com/blog/clinical-data-validation-when-to-transition-from-p21-community-to-enterprise/