Every clinical trial's credibility rests on the quality of its sites. Protocol deviations, consent issues, source data discrepancies, or inadequate oversight can invalidate critical endpoints and jeopardize entire development programs. With sites spanning continents, cultures, and healthcare systems, maintaining consistent quality standards requires systematic evaluation and improvement.
Clinical site audits must balance thoroughness with efficiency. Over-auditing wastes resources and damages relationships. Under-auditing misses critical issues until a regulatory inspection. The key is risk-based approaches that focus on what matters most—subject safety, data integrity, and protocol compliance.
Our clinical auditors bring decades of experience across therapeutic areas, trial phases, and global regions. We understand both regulatory requirements and operational realities at the site level.
Is your team using Veeva as your eQMS? In addition to conducting audits, we can complete your data entry directly within your Veeva system, saving you significant time and attention.
Our dedicated project support team works directly with our auditors to streamline the process of inputting audit reports into the Veeva platform. We’ll guide your Veeva Administrator through the steps to confer the necessary user permissions in the platform and take care of the audit input on your behalf.
Contact us to learn more about integrating Veeva management into your auditing service so you can focus on your core operations.