• Audit of investigative site operations to determine adequacy of documentation and procedures, and to ensure your trial will be carried out in a controlled manner, per protocol, and in compliance with regulations
• Audit of ongoing and completed studies (Phases I-IV) at investigative sites to determine site and monitor compliance with applicable regulations (21 CFR Parts 50, 54, 56, and 312/812), FDA Compliance Programs, the study protocol, and Standard Operating Procedures and guidelines, as well as to ensure documentation is appropriate for a regulatory inspection.
• Audit of Phase I units and PK/PD studies
• Audit of Institutional Review Board operations and documentation for compliance with Protection of Human Subjects and Institutional Review Board regulations (21 CFR 50 and 56) and for responsiveness to the sponsor's needs
• Audit of sponsor central file record archives
• Audit of clinical study data listings
• Audit of clinical and non-clinical study reports
• Audit of sponsor or contract bioanalytical laboratory systems to assess sample assay performance and adherence to established procedures, industry standards, and FDA guidance for method validations, sample assays, and data reporting
• Audit of toxicology laboratories and studies to assess GLP compliance and accuracy of reports
• Audit of bioanalytical method validations, data and final reports
GCP, GLP, and BioAnalytical Audits
