DIA Japan 2025

The Pinnacle 21 Enterprise (P21E) platform is designed to transform and accelerate the clinical data lifecycle with precision and efficiency.  Define.xml is a critical component of regulatory submissions for SDTM, SEND, and ADaM datasets. P21E simplifies this process by automating the creation of define.xml files, dataset metadata, annotated CRFs, and Reviewer’s Guides. With built-in validation and intuitive tools, you can ensure your submissions are accurate, compliant, and ready for approval.

Our cloud-based solution is recognized for its reliability and innovation – proudly adopted by the FDA, the PMDA, 24 out of the top 25 biopharmaceutical companies, and 12 of the top 15 leading global CROs.