View transcript
Rising data volumes and compliance demands, especially in later phase studies, are increasing complexities in clinical trial data validation.
Relying on basic validation tools can introduce risk, delays, and missed insights. Pinnacle 21 Community is a good starting point for basic validation, but enterprise scale submissions and later phase studies require a submission ready approach.
With Community, teams manage issues offline, track versions manually, and lack visibility across studies. There’s no audit trail, no built in collaboration, and no measure of submission readiness.
Pinnacle 21 Enterprise overcomes these issues, bringing validation, issue management, and submission readiness together in one collaborative platform. Continuously aligned with the latest global regulatory requirements, Pinnacle 21 Enterprise validates data using the most up to date validation engine and provides a data fitness score guiding you towards submission readiness.
Automate up to 80% of define.xml creation and generate reviewers guides instantly with Enterprise, reducing manual effort and accelerating submission timelines. Track, assign, and resolve issues in one place with full audit trails, impact prioritization, and real time collaboration. No more spreadsheets and no more guesswork.
The result? Higher quality data, fewer delays, and greater compliance assurance at submission.
Ready to gain compliance assurance and time savings with Pinnacle 21 Enterprise?
Learn more here: certara.com/p21-validation
Make an inquiry about Pinnacle 21 Enterprise
Pinnacle 21 Enterprise builds on Community’s core validation capabilities with:
Make an inquiry to learn how your organization can benefit from reduced risk, increased quality, and guided submission readiness with Pinnacle 21 Enterprise.
