Case Study: Small Specialty Biopharmaceutical Company achieves comprehensive TMF consolidation, quality control, and electronic archiving with Advarra

Small Specialty Biopharmaceutical Company - Customer Case Study

Small Specialty Biopharmaceutical Company engaged Advarra to address significant TMF issues after purchasing a compound while multiple US and EU studies were ongoing. The Sponsor lacked internal ex‑US regulatory knowledge, physical space and resources to reconcile legacy Trial Master Files, and had concerns about CRO oversight and the integrity and completeness of the prior TMFs. Advarra was contracted to inventory, quality control, scan and electronically file the TMFs and support CSR appendix compilation and project management.

Advarra assigned dedicated inventory, scanning/electronic filing and Quality Control teams, developed a standardized TMF index and naming conventions, reviewed and re‑filed sections, scanned documents to PDF, and built a hyperlinked Master Tracker as the TMF table of contents. Missing or deficient documents were flagged for CRO follow‑up, QA sampling verified process adherence, boxes were archived off‑site, and electronic files (including the Master Tracker) were delivered on DVD and uploaded to the Client’s server. The solution improved TMF completeness, accessibility and regulatory readiness and was delivered on‑time and under budget.