Case Study: Clinical Trial Management System achieves strengthened GCP compliance and streamlined corrective actions with Advarra

Clinical Trial Management System - Customer Case Study

Customer: Clinical Trial Management System faced rapid clinical program growth and serious gaps in GCP compliance—deficient written procedures, weak global trial management, and inadequate SAE tracking and follow‑up. They engaged Advarra (Advarra Consulting) for clinical quality consulting services, including Computer System Validation, to assess and prioritize corrective actions.

Advarra implemented prioritized corrective action plans over a nine‑month program, mapping 14 key Clinical Operations and CTMS process areas, performing an SOP gap analysis, developing or enhancing 30 standards, and training relevant staff. As a result, Advarra helped remediate the identified deficiencies, strengthen GCP standards and SAE processes, and improve overall regulatory compliance.