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wThomasKoch
GCP Consultant
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Audits / Vendor Assessment
Inspection Readiness and Training
Data Privacy / Data Integrity
Computerized System Validation
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How is your provider helping you maintain the integrity of your clinical data?
April 28, 2017
How is your provider helping you maintain the integrity of your ePRO data?
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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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I live in Fabulous New York
but my clients are global in scope.
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