Case Study: Top 10 Global Pharmaceutical Company subsidiary achieves GCP compliance and enhanced global clinical trial oversight with Advarra

Advarra Consulting Delivers Clinical Trial Management Oversight

The Top 10 Global Pharmaceutical Company faced rapidly expanding clinical programs running complex therapeutic studies without a GCP‑compliant clinical trial infrastructure. Written procedures were deficient, SAE tracking and investigator site oversight were inadequate, and study startup risks threatened regulatory compliance. Advarra Consulting, through its Clinical Center of Excellence, was engaged to provide comprehensive clinical quality and GCP compliance services.

Advarra deployed a team of clinical quality practitioners, GCP experts, and regulatory specialists to perform audits and gap analyses (Phase I) and then implement technology oversight and a corrective action plan (Phase II). The work included computer system validation, CTMS user requirements, mapping corrective actions across 14 key process areas, developing or enhancing 30 standards with training, and nine months of targeted GCP improvement activities. As a result, Advarra mitigated critical regulatory risks, enabled compliant study startup activities, and established strengthened global clinical trial management oversight.