wThomasKoch

GCP Consultant

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  • Services
    • Services
    • Audits / Vendor Assessment
    • Inspection Readiness and Training
    • Data Privacy / Data Integrity
    • Computerized System Validation
  • Blog
  • Contact
 

Data Privacy / Data Integrity

  • AIPP CIPP-US Certification
  • Privacy audits & assessments
  • GDPR Assessment and Readiness

Privacy / Data Protection authorities and regulations, including the impending GDPR, can be complex to apply in a clinical trial context. In addition, in the US many investigators work in institutions that by policy apply the U.S. HHS HIPAA regulation to clinical trial data collection systems. Addressing these complexities and resolving potential conflicts effectively is vital to a successful compliance strategy.

Pages

  • About
  • Services
    • Audits / Vendor Assessment
    • Inspection Readiness and Training
    • Data Privacy / Data Integrity
    • Computerized System Validation
  • Blog
  • Contact

I live in Fabulous New York

but my clients are global in scope.

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