Simone Ariane Ahrens-Mende

Ensuring Compliance and Data Integrity in eClinical Systems for Biometrics Services

A Talk by Simone Ariane Ahrens-Mende (Director DM and Biostatistics, KLIFO)

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About this Talk

This presentation addresses compliance and data integrity in eClinical systems within clinical research. We’ll review key EU regulations that set standards for data security and accuracy and discuss practical strategies for aligning eClinical technologies with these requirements, including change control, validation, and risk management. Drawing on over 20 years of experience, I’ll share insights from implementing eCRF systems, equipping participants to effectively manage eClinical systems in a regulated environment.

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07 November 2024, 03:50 PM

03:50 PM - 04:10 PM

About The Speaker

Simone Ariane Ahrens-Mende

Simone Ariane Ahrens-Mende

Director DM and Biostatistics, KLIFO

She has over 23 years of experience in clinical research, with a strong focus on maintaining data integrity and compliance within eClinical systems. Her expertise includes navigating EU regulatory frameworks and implementing best practices for data management and risk control within clinical trials​

Simone Ariane Ahrens-Mende

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