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PharmaSUG SDE – 2024

PharmaSUG SDE – 2024

Although the industry is familiar with preparing SDTM data, there are still many do’s and dont’s to be aware of that are crucial to getting your submission right first time.

Learn from our SDTM experts and raise your game to de-risk submissions, and avoid costly delays.

Certara’s Data Sciences platform combines the capabilities of Pinnacle 21 and Formedix ryze, to streamline clinical data flow from design and collection to conversion and submission.

Powered by our clinical metadata repository, Certara clients achieve faster cycle times from study setup to database lock, resulting in faster therapy development.

– Reuse of approved content for faster study setup
– Quicker eCRF design and approvals
– Automated EDC build
– On-demand SDTM dataset generation
– In stream data validation and issue management
– Define.xml and Reviewer’s Guiode generation

With metadata-driven technology, we reduce data silos across data standards, data management, and statistical programming teams.

Our fully managed cloud platform is adopted by the FDA, PMDA, 24 of the top 25 biopharmaceutical companies, 12 of the top 15 CROs, and hundreds of sponsors and CROs worldwide.

Can’t attend the conference? Get up to speed on best practices for mapping your clinical trial data to CDISC SDTM with our free guide.

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