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Fueled by automation to remove one of the biggest barriers to adoption
Increasingly, research sites are not just asking how to digitize document management, but how to connect their document management system to the rest of their clinical operations without adding operational burden. The growing adoption of Advarra’s eReg—a secure, paperless electronic Investigator Site File (eISF) system integrated with OnCore and Clinical Conductor, the most widely used clinical trial management systems (CTMSs) among research sites—reflects the shift toward integrated technology that enhances operational visibility and supports long-term scalability.
Advarra’s eReg system has experienced steady adoption among research sites and institutions over its more than six years in the market, with particularly strong growth in the past 12 months. During this recent period, the system has seen a 60% rise in documents managed and signatures processed, underscoring its significant role within Advarra’s site solutions portfolio.
Standalone document management systems can’t keep up
For many sites, electronic document management systems solved an immediate problem: replacing paper binders with digital storage to modernize operations. That shift brought meaningful gains, including staff time savings, secure remote access, stronger version control, and improved inspection and monitoring readiness.
But as study portfolios continue to grow, so does complexity. Regulatory documents sit at the center of study startup, compliance, operational performance, and ongoing study management. When those documents live in a standalone system, teams often rely on manual workflows, duplicate data entry, and disconnected processes to bridge operational gaps, which can create friction over time.
“After selecting OnCore CTMS, we made a strategic decision to eliminate disparate systems and duplicate data entry by transitioning to a fully integrated technology stack,” said Chris Moore, senior director of clinical research at the University of Mississippi Medical Center. “Our goal was to avoid the inefficiencies of disconnected systems, such as resource strain, compliance risks, data silos, and workflow disruptions.”
Advarra’s eReg integrations set the standard for a connected ecosystem
Sites need connected infrastructure that streamlines workflows, unifies data visibility, and reduces redundancy. Advarra’s eReg solution connects with systems sites rely on every day including:
- Advarra’s eIRB platform, called CIRBI
- OnCore CTMS
- Clinical Conductor CTMS
- Site email systems
- Local eIRB systems
These integrations enable regulatory documents to move in concert with the rest of a site’s clinical operations. This connectivity helps reduce administrative burden, streamline study approvals, automate alerts, and enable delegation of authority logs. It also aligns regulatory processes within the broader study lifecycle, improving internal oversight and analytics.
“As our study volume increased, we realized our legacy regulatory system wasn’t keeping pace with our integration and scalability needs,” said Ashlee Lang, director of the Office of Clinical Research at the University of Rochester Medical Center. “We ultimately made the strategic decision to transition away from that system to Advarra eReg, which allowed us to consolidate platforms and align regulatory workflows directly with OnCore CTMS as the single source of truth. It’s been a gamechanger.”
Removal of migration barriers to connected eReg and CTMS
Even when the benefits of integration are clear, the decision to move away from a standalone document management system has historically been limited by one concern: migration.
Transitioning from one document management system to another often requires moving documents one at a time, which is a highly manual, time-intensive, and costly process for site teams, typically spanning six to 18 months.
To reduce this friction, Advarra developed an automated tool to cut down the migration time by up to 90%. It enables expedited, seamless bulk document transfers that digitize and simplify the transition process. Rather than facing the heavy administrative burden of traditional document migration, sites can now use an out-of-the-box automation tool to move from standalone eISF systems to a fully connected environment where documents flow automatically between Advarra’s eReg and CTMSs.
A connected foundation built to support scalability
Technology decisions today are about more than replacing paper. They’re about building connected infrastructure for future study growth that:
- Streamlines workflows across regulatory and operational systems.
- Improves collaboration between site staff.
- Reduces administrative burden and increases efficiency.
- Provides greater visibility into document status and inspection readiness.
For sites evaluating whether to maintain a standalone system or move toward a connected ecosystem, the question is shifting from “Can we digitize?” to “How do we integrate?”
Learn more about Advarra eReg and request a demo at www.advarra.com/ereg.
