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.