wThomasKoch

GCP Consultant

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

Audits / Vendor Assessment

  • GCP-ICH Compliance
  • Electronic Records; Electronic Signatures (21CFR Part 11) Compliance
  • Data Integrity
  • Mock Inspections
  • Vendor Assessment

A unique cross-domain perspective on system validation, data integrity, and clinical trial conduct enables Tom to conduct comprehensive and thorough audits, risk analyses, and training as well as provide effective consultation to help you meet a broad range of the regulatory challenges facing sponsors, CROs, and investigators across the contemporary clinical trial landscape.

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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