KPE Research offers a staff of highly experienced clinical auditors that are well versed in the FDA regulations and ICH guidelines that govern clinical research. We understand the importance of quality assurance at each step in the process to ensure clinical data integrity as well as regulatory compliance. Our auditing services include:

• Conducting GCP audits at client offices and at investigational sites.
• Developing and implementing audit plans in collaboration with the Sponsor’s quality assurance policies and personnel.
• Providing timely, comprehensive audit reports.
• Mediating corrective actions as appropriate.