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 文件是 SDTM、SEND 及 ADaM 数据集监管提交的关键组成部分。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.