Resource Library

EMA (EU) 536 - Clinical Document Redaction in the Spotlight

The Clinical Trial Disclosure and Transparency regulatory landscape has undergone a substantial transition in recent years. Regulatory bodies around the...

Data Anonymization with Short Timelines & Missing Datasets

Performing Quantitative Risk Assessments Without Access To Trial Datasets The sponsor organization started the PRCI process with an initial Process...

Anonymizing Rare Disease Data

Avoiding Delays when seeking compliance for Rare Disease Populations The challenges facing the Sponsor required the  Real Life Sciences and...

Proactively Preparing For Risk Based Disclosure Submissions Across Therapeutic Areas

Operationalizing a scalable process to manage growing demands for anonymization Most sponsors are experiencing pressure to achieve deadlines from Regulators...

Rare Disease Data & Document Anonymization

"ULTRAGENYX is committed to sharing information about our research to help advance future development in rare diseases. Performing robust, accurate...
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