At the recent CDISC EU Interchange in Berlin, Angelo Tinazzi, Director of Clinical Data Standards and Submissions at Cytel, showcased a popular poster presentation analyzing the differences between the Pinnacle 21 enterprise (P21e) and community versions. Those working in the field of data standards, will know that Pinnacle 21 is led by the team that created OpenCDISC, and is now the leader in software and services for managing CDISC compliance and clinical data quality. The organization continues to offer a community based software tool, in line with the OpenCDISC model, but now offers an enterprise version to sponsors and CROs, that is also used by the FDA itself.
Angelo's poster provides a critical review of the added value of the Enterprise commercial version, based on his experience of introducing and using the software within Cytel. He concludes that overall the Enterprise version of Pinnacle 21 is more effective at helping users to manage compliance issues, by providing additional compliance reports. The enterprise version also helps users to better anticipate the issues that might be flagged by the FDA, and saves time in generating submission documentation, such as define.xml and the reviewer guide for SEND, SDTM and ADaM packages.
To learn more, and download a .pdf copy of the poster, click the button below.