2025 CDISC + TMF Europe Interchange

Presenter: Gilbert Hunter, Senior Customer Success Manager, Certara Pinnacle 21

Abstract: Compliance with CDISC data standards is mandatory for clinical trial submissions to the FDA, PMDA and MHRA. However, adopting CDISC standards isn’t just a necessity. It’s an important investment that enables more meaningful research, and deeper data insights. Complying with CDISC data standards is an ongoing challenge for many organizations.

This presentation explores best practice processes to support and achieve successful implementation and compliance with regulatory requirements. We examine the concept of ‘designing studies with the end in mind,’ through early standards adoption. Essentially, how implementing industry standards from the start of a study, and designing a compliant trial upfront, rather than leaving compliance to the end, is the ultimate blueprint for best practice.  We also examine the essential role of software in creating and maintaining clinical metadata standards.

In conclusion, we demonstrate through a case study how end-to-end standards implementation can be leveraged to not only achieve compliance, but also facilitate greater quality and consistency, as well as faster delivery of submission deliverables.

Authors: Julie Ann Hood/Seiko Yamazaki ​

Preparing SDTM and ADaM data packages for submissions can be a daunting task. With all the guidance documentation and checks for files and data needed for submission, it’s easy to get overwhelmed. This presentation will highlight essential documents to reference for submissions to both FDA and PMDA. A focus will be placed on key review items for non-automated checks, as well as critical cross-checks spanning both study data and submission documents to serve as a foundational resource. Attendees will be able to leverage this framework to create a more comprehensive checklist that will enhance their organization’s own submission process.