Case Study: ATHN achieves FDA-ready real-world data standardization with Certara

Standardizing Real World Data in Rare Disease ATHN’s Journey

The American Thrombosis and Hemostasis Network (ATHN) faced the challenge of standardizing its Real World Data into CDISC SDTM format for two FDA submissions within a demanding four-month timeline. With limited in-house regulatory compliance experience, ATHN partnered with vendor Certara and used its Pinnacle 21 clinical data management and automation suite to address this need.

Certara implemented a managed service that included training ATHN’s team, performing the SDTM mapping and conversions, and creating all necessary tables and figures. This solution successfully delivered both FDA-compliant datasets on time, enabling the sponsor to use the data for analysis and regulatory submission. The partnership also enhanced ATHN’s future capability for independent data submissions, unlocking the potential of its valuable dataset to advance research and improve care for patients with rare blood disorders.

American Thrombosis and Hemostasis Network (ATHN)

Christine Gerber

Senior Project Manager