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)
