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ACDM 2025

ACDM 2025

Visit Pinnacle 21 and see how to accelerate study setup

The Pinnacle 21 Enterprise platform streamlines and expedites your end-to-end clinical data flow. Powered by our Clinical Metadata Repository, clients achieve faster cycle times, from study setup to database lock – resulting in faster therapy development. Our cloud platform is adopted by the FDA and PMDA, aswell as 24/25 leading biopharmas, and 12/15 top 15 CROs. Come and see how you can leverage our platform to build studies with greater speed and accuracy!

Poster Presentation: Elevate Your Game: Leveling Up SDTM Validation With the Magic of Data Managers

Selecting players armed with unique abilities to collaborate is key to crafting an unbeatable strategy, whether on the field, navigating a quest, or in the office. In standardized clinical trial data, this can break down departmental silos and enhance study data quality, leading to more effective treatments sooner. Historically, SDTM programmers handled validation report issues, but some rules require tracing SDTM data back to raw data or data collection to optimize decision-making.

Integrating data managers can slash resolution time and boost data quality. This poster will provide guidance on weaving data managers into the SDTM validation process and unveil different workflows to level up your approach to resolving validation issues.

Curating appropriate FDA validation rules will showcase how these are best served by the unique positioning of data managers. Lastly, suggested training and ideas to power-up your data managers will equip you to battle issues and conquer those data demons.

Julie Ann Hood, Principal CDISC Consultant

Jen Manzi, Senior CDISC Consultant

Stop by Booth 5 to see how much quicker you could go from protocol to submission with Pinnacle 21 Enterprise. Alternatively, you can always pre-book a free, no- obligation software demonstration. Simply complete the form below advising your preferred date/time, and tell us a little bit about what you’re looking to achieve or the challenge(s) you’re looking to address.