Top 10 Biopharma Achieves Significant Regulatory Efficiency

The Challenge

Electronic trial master file (eTMF) systems are an important tool for research organizations to maintain compliance with regulatory agencies and present a historical look at the actions that have been taken over the course of a clinical trial. Study documentation in an eTMF typically come from multiple sources. Direct integrations of other systems with an eTMF result in less manual data entry, providing significant time savings, improved quality, and increased operational efficiency.

The Ask

A top 10 biopharma company approached Advarra to pilot an integration between their eTMF system and Advarra’s IRB platform. Advarra and the biopharma company assembled project teams focused on the implementation of real-time document transfer for central IRB documentation and communications, the reduction of the number of eTMF errors from manual input, and an increase in inspection readiness.