Case Study: University of Nebraska Medical Center achieves streamlined regulatory management and faster study startup with Advarra eReg

University of Nebraska Medical Center Streamlines Regulatory Management and Accelerates Study Startup with Advarra eReg

The University of Nebraska Medical Center sought to move away from paper regulatory binders and adopt a 21 CFR Part 11–compliant eRegulatory platform to support a large, diverse research portfolio and enable remote workflows during the pandemic. To meet this challenge, UNMC rapidly implemented the Advarra eRegulatory Management System (eReg) across the institution to centralize and standardize regulatory management.

Advarra’s eReg solution, integrated with Advarra IRB/CIRBI and email systems, automated document exchange, enabled protocol-specific inboxes, and provided controlled remote monitoring and e-signature capabilities. Within eight months UNMC had 349 users, 116 protocols and ~13,800 documents; by March 2023 those figures grew to 666 users, 242 protocols, 41,131 documents, 365 monitor review sessions (an >800% increase) and more than 21,000 signatures—demonstrating measurable acceleration of study startup and remote oversight enabled by Advarra.

University of Nebraska Medical Center

Courtney Kennedy

Manager of Clinical Trials Applications