Top Biopharma Enhances Regulatory Efficiency

A leading biopharmaceutical company managing a significant volume of regulatory documents annually aimed to improve regulatory efficiency and automate essential workflows between its IRB Platform and electronic master file (eTMF). A crucial part of clinical trials, the eTMF typically comes from multiple sources and is used by research organizations to maintain compliance with regulatory agencies and present a historical look at the actions taken throughout a study.

By integrating the eTMF with an IRB, teams can reduce manual data entry, providing significant time savings, improved quality, and increased operational efficiency. To make the transition, the biopharma company approached Advarra to pilot an integration between their eTMF system and Advarra’s IRB platform.

Access the case study to learn how Advarra and the biopharma company were able to assemble project teams focused on implementing real-time document transfer for central IRB documentation and communications, reducing the number of eTMF errors from manual input, and increasing inspection readiness.