Case Study: Mid-Size Device Company achieves global GCP compliance and strengthened clinical quality with Advarra

Mid-Size Device company - Customer Case Study

Mid-Size Device Company, a subsidiary of a top-20 global pharmaceutical firm, was running global IND-governed trials using an approved device with an FDA-approved drug but lacked a clinical trial infrastructure and written procedures to sustain GCP quality standards. Advarra identified significant deficiencies in global trial management and SAE tracking and follow-up that created ongoing compliance risk and required prioritized corrective action.

Advarra implemented a nine-month clinical quality program that mapped 14 key clinical operations/process areas, developed new standards, evolved CAPAs, and trained relevant personnel. Using CSV, internal, investigator-site and SAE audits plus CTMS requirements development and a detailed CAPA roadmap, Advarra strengthened SAE tracking and global trial controls and established a sustainable framework to support ongoing GCP and regulatory compliance.