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Clinical Data Disclosure, Transparency and Plain Language Summaries
February 25-26, 2025
The Bellevue Hotel, Philadelphia, PAHybrid Event I Attend Live In-Person or Online

Lee Berry
Senior Manager, Clinical Trial Disclosure & Transparency at CSL Behring
Speaker

Profile

Lee Berry is the Associate Director Data Transparency Lead of Clinical Trial Disclosure and Transparency for CSL Behring. She started her journey in the Pharmaceutical Industry in 1999, and has held several positions within the Clinical Operations and Clinical Development functional areas. Her experience in Clinical Trial Disclosure and Transparency started eight years ago. Her scope of work at CSL has included Clinical Trial Registrations and Results postings, Plain Language Summaries, and Submission Strategies for EU CTIS, EU Policy 70, and Health Canada. She currently leads her team and collaborates with multiple functional areas with the redaction and anonymization of clinical documents as required by various Health Authorities. Lee has worked on the development of SOPs and process improvements, and continues to endeavor towards process efficiencies, ensuring the public dissemination of study information is meaningful and transparent for healthcare providers, study participants, patients, and the general public.


Agenda Sessions

  • Examination of risk-based clinical document anonymization techniques and related processes to support PRCI and Policy 0070 submissions across a subsection of commercial sponsors and practical use cases.

    1:30pm