wThomasKoch
GCP Consultant
Do you understand your data integrity and inspection risks?
May 6, 2026
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GDPR, Data integrity, Clinical Research and YOU:
Inspection Readiness – A Marathon, Not A Sprint
Root Cause Investigation – Foundation of CAPA
ICH E6(R2) – Addendum Highlights/CSV & Data Integrity
ICH E6(R2) – Addendum Highlights – Risk
Greatest Risk to Data Integrity – People
eSource – Meeting Regulatory Expectations
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Ensuring Compliance—Enabling Trust
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