• Audit of data management, biostatistics, and information technology systems for the entry, management, and reporting of clinical investigation data
• Audit of Computer System Validation (CSV). Assessment of validation packages for Clinical Data Management and Reporting, Laboratory Information Management Systems (LIMS), or other data collection systems
• Audit of Clinical Operations, Project Management, and Monitoring Systems; Medical Writing; Regulatory Affairs; Safety Systems; and Medical Monitoring
• Audit of Contract Research Organization (CRO) operations and systems to assess client satisfaction, conformance with SOPs, and regulatory compliance
• Audit of Remote and Web-based Data Entry Systems
• Audit of Interactive Voice Response Systems (IVRS)
• Audit of 21 CFR Part 11, Electronic Records; Electronic Signatures Compliance
• Audit of Central Reading Facilities (ECG, radiology, etc.)
• Audit of Clinical Pathology Laboratories and Esoteric Testing
• Review and/or assistance in the preparation of validation protocols
• Assessment of documentation and audit of data to support the validation effort, system security issues, and archival/backup requirements
• Reconciliation of Serious Adverse Events (SAEs)
• Audit of investigational product packaging, labeling and distribution
• Due diligence audits
Sponsor, CRO, and Vendor Audits (Qualification or In-Study)
