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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...

EMA Regulation (EU) 536/2014 Resource List

Description Source Link Helpful For… Sponsor Handbook EMA Link Getting started and familiarizing with CTIS requirements CTIS Training Dates, Registration...

January 2022 Webinar: Manage "Practical Strategies for Successfully Navigating Your Health Canada PRCI Regulatory Disclosure Projects"

Get your organization ready for disclosure projects in 2022 as Health Canada expects quantitative methodologies in support of Clinical Trial...

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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