A note from Lauri Carlile, Chief Research Services Officer:

For more than 40 years, Advarra’s institutional review board (IRB) has been built on a simple commitment: quality, clarity, and care in every review. That commitment hasn’t changed, and it never will. What does change—what has to change—is how we deliver on it. The research community moves faster every year, and the sponsors, sites, and CROs we serve deserve oversight that is as thoughtful and rigorous as it has always been, paired with the speed, expertise, and transparency that modern research demands.

That’s why I’m so proud of the work our team has done on the next generation of CIRBI, Advarra’s eIRB system. Every decision behind this system started with the researchers who use it and the volunteer participants who depend on the integrity and oversight of their studies. It reflects who we are at our core: intentional in how we innovate, deeply expert in the work we do, and unwavering in our independence. The enhancements we’ve built lay the foundation to leverage AI-powered workflows that make the submission process faster and smarter—but as we embrace the technologies shaping the road ahead, we will never lose sight of what, and who, makes this work matter: Decisions about ethical review and participant protection are, and always will be, made by people, not AI. That’s what keeps us grounded, even as everything around us accelerates.

As proud as we are of what we’re launching this summer, I want to be clear that this is just the beginning. We’re opening the door to even more meaningful innovation in the months and years ahead. I’ll let Tamas Peterson, our head of product management, walk you through it.

Over the last two years, I’ve been lucky enough to immerse myself in the world of our IRB technology. Advarra’s IRB has been built brick by brick to deliver the most complete, consistent submission, review, and oversight process we can, and our Center for IRB Intelligence system, CIRBI, has been central to that growth. CIRBI has accelerated communication speed and submission accuracy while giving research teams a single point of interaction for both submitting to the IRB and retrieving artifacts for approved studies.

So, I’m genuinely excited to be launching the next generation of CIRBI this summer. When we set out to enhance our current system, we knew we had big shoes to fill—CIRBI has been the backbone of our IRB for decades. Revamping it meant staying true to what got us here in the first place: simplicity, efficiency, quality, and transparency at every step.

With Advarra’s IRB overseeing more than half of all industry trials, CIRBI was designed to manage research at scale. The system supports 72,000 active research sites—acting as a centralized management solution for multi-site studies with hundreds of sites, while also bringing that same level of care to smaller multi- and single-site studies. Submitting new studies, amendments, and clarifications, along with centralized documentation, all stay front and center, so the quality you rely on from Advarra never misses a beat.

But we couldn’t just meet the needs of today; we also had to think about the future. Over the last 40 years, CIRBI has become the gold standard for IRB workflows. This next generation modernizes that system rather than replacing it, preserving everything researchers trust while rebuilding it on technology infrastructure designed for what’s ahead. The result is software that’s modern but familiar: All the benefits of the latest technology, delivered in the experience you already know. That means we can now deliver new features, integrations, and AI-powered workflows faster than ever—scaling with the growing needs of the research community.

We hope that when you get into the system, you’re both surprised and right at home. The look and feel have changed, but the workflows you’re used to are still the same. The dashboards and submission pathways you’ve relied on for years have been recreated with care, with new visual elements and data added to make tracking your studies easier than ever. New color-coded status indicators let you understand where any submission stands at a glance—so you always know who’s responsible for the next action. And filtering has been a big focus: You can now apply multiple filters at once for fast, dynamic sorting across complex portfolios.

One of the best parts of working on this next iteration was setting ourselves up for the future. CIRBI development is conducted by an in-house team of software experts who’ll keep optimizing it for years to come. Some improvements include a cleaner interface, much faster load times, and a more responsive platform across the board. It’s already opening new avenues for collaboration, enabling more real-time document delivery through our Advarra eReg and sponsor eTMF integrations, and, through Advarra SSO, setting the stage for more seamless communication between Advarra applications down the road.

The time saving features that CIRBI pioneered have been refined. For site teams, details about your principal investigator and research location help populate the submission form, so you spend as little time as possible building your submission. As we gather more submission details, we’ll keep refining this process to drive that time down even further. The same applies to the clarification process, which remains an integrated part of your submission—easily tracking communication between you and the IRB, fully audited, with notifications delivered both in-app and over email. And when you do have a question, CIRBI connects you directly with knowledgeable Advarra IRB experts inside the workflow for faster answers and fewer back-and-forth cycles.

Ultimately, your time as researchers is one of the most precious commodities you have. Reducing the burden of entering data and submitting to the IRB—and getting you back to the important work you do—is central to how we think about every new feature. Most of our customers have migrated into the new system, and once that stage is complete for everyone, we’ll share a roadmap of what to expect in the coming months. Be on the lookout for enhancements to how you interact with documents, submit across studies, and manage multi-site trials as we shift our focus from recreating the experience you know to enhancing it to its fullest potential.

There’s constant change in the research community. New regulations and technologies are always challenging how we’ve done things in the past, and how we can do them better. With the newest generation of CIRBI, we have a platform that lets us take advantage of the latest and greatest tools, leveraging machine learning to enhance consistency without impacting accuracy, and building dynamic solutions that draw on what we already know about your study to ask only for the key details we need to support your submission. Our goal with this system is simple: Make your experience better, faster, and smarter, while preserving the integrity and rigor of the IRB review process itself.

This isn’t a one-time chance to do better—it’s the start of an iterative cycle of design and improvement that we’ll keep building on for years. We’ve already been through that cycle with a number of users who were generous enough to be early adopters and share feedback. Workflows like our user registration, navigation, and meeting auditing have already been enhanced, thanks to your peers.

We’ll be scheduling demos of the application, and I encourage you to join for an early look. You’ll hear more from Advarra as your migration date gets closer, but if you have any questions in the meantime, don’t hesitate to reach out to your representative. I look forward to hearing what you think of the new system.

CIRBI: What’s New

  • Better visibility into status and next steps: Enhanced dashboards, consistent status color coding, and in-platform notifications help users quickly understand what requires attention, who owns the next step, and where work stands across studies and submissions.
  • Faster, more intuitive workflows: Guided submission creation, smarter forms, and visible progress indicators reduce friction for both new and experienced users, helping teams move through complex workflows with greater confidence and fewer delays.
  • Stronger support for adoption: Centralized submission workspaces, easier access to IRB-issued documents, and embedded support and training resources make the platform easier to use, easier to adopt, and better suited to organizations managing high volumes of studies and sites.
  • Connectivity for scale: Connected to Advarra’s eReg and sponsor’s eTMF, and better enabled for AI workflows.

Questions about the transition to CIRBI next-generation? Please reach out to your client success representative or contact us at support-CIRBI@advarra.com.

Kyle Naylor didn’t set out to work in the IRB world—but once he found it, he never looked back.  

Now a team lead supporting one of Advarra’s largest clients, Kyle brings together hands-on research experience, a deep appreciation for ethics and regulation, and a genuine passion for helping studies run smoothly. From his early days in biology and research at Walter Reed to his current role at Advarra, Kyle has seen firsthand how thoughtful processes, strong relationships, and the right technology can directly impact patients.  

In this Q&A, he shares what drew him to research, why Advarra’s mission resonated with him, and what excites him most about new improvements to Advarra’s eIRB platform, CIRBI. 

What first connected you personally to clinical research and the work you do today? 

My entry into research really started during my senior year at Stevenson University. I was a biology major and took an internship at Walter Reed, working directly with a research group. Being involved on the research side—and having that human interaction—made everything feel real. You’re not just working with data—you’re seeing how research connects to people. From there, I became more interested in the ethics and regulatory side of research, which naturally led me to the IRB space. Even now, hearing patient testimonials during Advarra meetings is a reminder of why we do this. We may work with documents every day, but on the other side, those approvals mean real treatments reaching real people. 

What made you want to bring that passion for research to Advarra specifically? 

Advarra felt like a place where the regulatory side of research truly connects back to the patient. Early on, I could see that Advarra wasn’t just focused on checking boxes. It was about making the process efficient, ethical, and meaningful. I imagined our products and services helping studies move forward without unnecessary friction, which ultimately helps participants get access to treatments faster. That alignment really mattered to me. Over time, seeing how much Advarra invests in training, collaboration, and customer relationships confirmed that this was the right place to build a career. 

How do you and your team go above and beyond for clients? 

A big part of it is being proactive instead of reactive. Recently, I visited a large client in person with my manager and other client engagement partners—not because anything was wrong, but to talk about efficiency and how we could make things even better. Putting a face to a name made a huge difference. Now, people know exactly who to reach out to, which cuts down on delays and confusion. On the backend, I coordinate closely with my team to distribute work evenly and step in when large, multi-site submissions come through. It’s about making sure clients feel supported while keeping everything moving smoothly. 

What excites you most about using CIRBI? 

CIRBI is really the backbone of how we support clients at scale. It keeps everything documented and accessible, so anyone can step in and keep a submission moving. What excites me about the latest and greatest version of the tool is the flexibility it’ll create, whether that’s simplifying submission forms or reducing common errors. Even small changes can add up to faster approvals and fewer back-and-forth questions. Ultimately, that efficiency means updated consent forms and critical information get to patients sooner, which is what this work is all about. 

Want to learn more? Check out this overview of Advarra’s review services or contact us to ask an expert a specific question. 

Estimated reading time: 4 minutes

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.

One user, a senior director of clinical research from the University of Mississippi Medical Center, said, “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. 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:

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.

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