Case Study: CDISC enables a university to achieve faster, compliant study builds with Certara Pinnacle 21

How one university overcame practical and cultural challenges to implement CDISC compliance

The Clinical Data Interchange Standards Consortium (CDISC) faced significant challenges when a US-based university needed to implement CDISC compliance. The university lacked internal CDISC knowledge and struggled with retrospectively mapping a study to CDISC's SDTM after an FDA submission was noted as non-compliant. They sought expertise from Certara, utilizing their Pinnacle 21 product and services to overcome these practical and cultural hurdles.

Certara implemented a multi-stage solution, performing a gap analysis, aligning case report forms with CDASH standards, reviewing existing data, and providing comprehensive training. This enabled the university to achieve faster and easier study builds, better data reuse, and full confidence in their CDISC compliance. The vendor's work ensured the university could successfully navigate data collection, SDTM mapping, and future regulatory submissions.

Clinical Data Interchange Standards Consortium (CDISC)

Ryan Miller

Business Development Manager