Pinnacle 21 Enterprise clinical data management software streamlines study setup, EDC build, SDTM mapping and validation in a centralized platform. This enables higher-quality deliverables and supports reduced risk, fewer delays, and faster time to submission.
Pinnacle 21®
Personalized demo of Pinnacle 21 Enterprise clinical data management software
Streamline your path to submission with faster, higher-quality data
Enterprise mitigates the compliance risk and delays of manual, fragmented workflows:
Accelerate study setup
Streamline study design and automate EDC build to achieve faster study go-live.
Improve quality & align with global standards
Align with the latest validation engines and ensure continuous data validation
Save time & increase consistency
Standardize and govern content in a Clinical MDR for up to 70% reuse, with full traceability across studies and standards.
Streamline SDTM mapping specs
Standardize and manage SDTM mappings centrally to improve quality and reduce rework.
Collaborate efficiently across stakeholders
Track, manage, and resolve issues efficiently with real-time collaboration across teams and vendors in a central platform.
What you’ll see in this demo of Pinnacle 21 Enterprise clinical data management software:
Select the specific areas you’d like to focus on, such as:
- How to create reusable standardized content and study metadata, including:
- CRFs (including visits, visit schedules, edit checks, annotations)
- SDTM mapping specs
- Define.xml metadata
- Controlled Terminology
- EDC specific form visualization – for in-stream review, edit & approval
- A fully functional EDC build (with edit checks & visit schedules)
- How Controlled Terminology is managed across EDCs, SDTM & ADaM – and maintained in line with CDISC updates
- Advanced validation features: alignment with latest validation engines, validation logs, report comparisons and ‘data fitness’ scores (part of the Pinnacle 21 upgrade to Enterprise)
- Issue management, including in-stream issue tracking, resolution, and analytics dashboards
- Automation of submission deliverables, including Define.xml and Study Data Reviewer’s Guides
Book a demo today
Schedule a demo or consultation to see how Pinnacle 21 can accelerate your path from study design to submission.
"Pinnacle 21’s MDR is very intuitive and user-friendly, so there is no steep learning curve like you might get with other systems. The integrated validation mechanism means we can do real-time validation, right from the start.”
Radhika Kale
Associate Director of Statistical Programming Standards, Alnylam Pharmaceuticals
Driving results for leading pharma organizations
About Certara
Certara is dedicated to transforming drug discovery and development for good. We harness the power of biosimulation, advanced analytics, and regulatory expertise to create a future where treatments reach patients faster and more efficiently.
From discovery to market access and commercial, we tailor solutions to meet our clients’ most pressing challenges. Through strategic leadership and advanced predictive technologies, Certara provides comprehensive solutions to optimize drug development processes, reduce risks, and improve outcomes. Our clients include more than 2,400 biopharmaceutical companies, academic institutions, and regulatory agencies across 70 countries.
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