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Mapping clinical data to CDISC SDTM is mandatory for clinical trial submissions. But accurately mapping to SDTM is increasingly complex and time consuming, especially when it’s done the traditional way with spreadsheets.
You’re repeatedly creating specs from scratch, which is inefficient and leads to inconsistencies and manual errors. Plus, it’s hard to keep track of all the different versions and changes. Managing compliance with evolving regulatory standards is So emission.
Overall, it’s not a great outcome. There’s a smarter way with Pinnacle twenty one Enterprise Plus, the collaborative workspace that transforms SDTM mapping. With Pinnacle twenty one Enterprise Plus, you get faster study setups. You can efficiently manage study metadata in a centralized platform. You have complete traceability and in stream validation allows you to resolve compliance issues upfront. As a result, you’re looking at faster, higher quality, more consistent submissions together with greater team productivity.
Streamline your SDTM mapping today.
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Learn how the Pinnacle 21 Enterprise Plus SDTM specification management tool helps you map source data to target SDTM with greater speed, quality and consistency.
– Faster study specifications
– Full traceability and governance
– Streamlined workflows and issue resolution
