Case Study: Leading Clinical Research Organization achieves intensified compliance by automating audit and CAPA with MetricStream

Leading Clinical Research Organization Intensifies Compliance By Automating Audit And Corrective Action

An international, U.S.-headquartered clinical research organization with thousands of associates and global operations needed to tighten quality and regulatory compliance while speeding decision-making. Its audit and CAPA activities were managed manually (spreadsheets, calls, emails) and a legacy point solution lacked scalability and flexible reporting, resulting in poor visibility, slow report generation, duplicated work, longer cycle times and elevated regulatory and operational risk.

The company deployed MetricStream’s GRC platform and out‑of‑the‑box audit and CAPA modules (role‑based access, automated workflows, 8D CAPA methodology, dashboards, alerts) for ~3,600 users to automate scheduling, checklists, investigations, escalations and reporting. The solution enabled closed‑loop audits and real‑time dashboards, accelerated report generation and clinical trial cycles, improved compliance and cross‑organizational visibility, boosted quality‑team productivity, and reduced audit costs and regulatory risk.