Case Study: UltraGenyx Achieves Reliable Rare Disease Data Anonymization with Real Life Sciences

UltraGenyx streamlines rare disease anonymization with Real Life Sciences ahead of EU Regulation 536/2014

The biopharmaceutical company UltraGenyx faced the challenge of anonymizing clinical trial data for its rare and ultra-rare disease populations. Their objective was to protect participant privacy while adhering to strict internal and regulatory standards, which is particularly difficult with small patient groups. To address this, UltraGenyx partnered with vendor Real Life Sciences to perform robust anonymization and quantifiable risk assessments.

Real Life Sciences implemented a solution involving comprehensive, technology-driven anonymization and risk modeling. This proactive approach, supported by a white paper defining best practices, enabled UltraGenyx to align cross-functional teams and secure early alignment with regulators. The collaboration with Real Life Sciences helped UltraGenyx avoid delays and time-consuming rework, leading to a more efficient disclosure approval cycle for their clinical trial results.

UltraGenyx