SCDM EMEA

Presenter: Gilbert Hunter, Senior Customer Success Manager

Abstract: Adopting CDISC standards isn’t just a regulatory necessity. It’s an important investment that enables more meaningful research and data insights. While complying with CDISC data standards is an ongoing challenge for many sponsor organizations, the many benefits outweigh the challenges. Our presentation will demonstrate best practice processes to achieve successful implementation of CDISC standards and compliance with regulatory requirements. We’ll examine the concept of ‘designing studies with the end in mind,’ through early standards adoption. We’ll look at how implementing industry standards from the start of a study is the ultimate blueprint for best practice. We’ll cover how to establish organizational standards, create an approved metadata content library, and associated governance and approvals processes.

Presenter: Ben Mant, Senior Standards Consultant

Abstract: Join us for an interactive session demonstrating how integrating metadata management with the core features of Pinnacle 21 Enterprise can significantly enhance the design and execution of your clinical studies. This session will demonstrate how P21 streamlines data harmonization, issue management, and submission readiness while ensuring compliance with global regulatory standards. We’ll also explore how modern metadata repositories enable collaboration, enhance standards reuse, and drive study automation for greater efficiency and consistency.