2024 CDISC Korea Interchange
Optimizing Efficiency and Improving Data Quality through Meaningful Custom Fix Tips and Explanations
Julie Ann Hood, Principal CDISC Consultant, Certara
Jennifer Manzi, Senior CDISC Consultant, Certara
Certara’s Data Sciences platform combines the capabilities of Pinnacle 21 and Formedix ryze – with in-stream CDISC compliance across the clinical data lifecycle.
Powered by our clinical metadata repository, Certara clients achieve increased quality and compliance across studies and standards, faster study setup, and earlier, more informed decision making.
Now you can ensure regulatory compliance and accelerate submission readiness with quality control, CDISC conformance, and fitness-for-use reports at your fingertips.
– Reuse of approved content for faster study setup
– Quicker eCRF design and approvals
– Automated EDC build
– On-demand SDTM dataset generation
– In stream clinical data validation and issue management
– Define.xml and Reviewer’s Guiode generation
We’re active members of the CDISC Data Exchange Standards team, and were involved in developing the CDISC ODM and Define models. For the past four years, CDISC have been using our platform to design and approve CDASH compliant CRFs, for use in the CDISC library.
Our 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.