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Meet the Author

Angelo Tinazzi

Senior Director, Statistical Programming

Angelo Tinazzi is Senior Director, Statistical Programming, Clinical Data Standards and Clinical Data Submission at Cytel. He is a well-published and recognized expert in statistical programming with over 20 years' experience in clinical research. The application of CDISC standards in different therapeutic areas is part of his core expertise since 2003, in particular in the context of data submission to health authorities such as the FDA and PMDA. Angelo is an authorized CDISC instructor and member of the CDISC ADaM Team as well as the CDISC European Committee, where he also manages the Italian-speaking CDISC User Network.

 

Featured Posts

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(Re)Integration Dilemma: Integrated Summaries of Safety and Effectiveness

As promised in my last post prior to PHUSE-EU Connect, I’d like to now share some reflections on my “Integration..
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Raising the Awareness for Additional FDA Data Submission Recommendations (Part I)

For years CDISC data standards implementers have struggled to find good implementation examples and use cases beside..
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Raising Awareness for Additional FDA Data Standards Submission Recommendations (Part II)

In the first part of this article, I raised awareness of the availability of additional FDA guidances containing CDISC..
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