The ROI of eRegulatory and eIRB Integration

Compliant, efficient document management during the various phases of a clinical trial is essential. Yet, throughout a trial, as documents are added to different systems for the investigator/institution and the sponsor, a great deal of time is spent managing those documents; and, of course, as with any manual process, there’s risk of error.

That’s why direct communication and integration between key technology systems like email, electronic institutional review board (eIRB) systems, clinical trial management systems (CTMS), and other eRegulatory (eReg) platforms all contribute to a more efficient and compliant trial. With hundreds or even thousands of files part of a trial’s documentation, an integrated eReg solution can facilitate vital time savings per document and ensure improved data quality – yielding a valuable return on the investment in the integration.

This article outlines common eReg management system integrations, and highlights a new integration already allowing sites to save hundreds or thousands of dollars per protocol.

Current eReg Integrations

As clinical research continues to move towards a remote environment, centralizing and integrating your regulatory management process and technology is vital to your institution’s success. There are common eReg integrations clinical trial sites are currently implementing.

CTMS Integration

An organization’s CTMS is commonly the source of truth for all protocol and participant information. CTMS data includes information related to protocols, staff, and your organization as a whole. This integration allows for organizations to level up their technological workflows, such as streamlining protocol creation within the system, associating staff with those protocols, and facilitating delegation of authority.

Email Integration

Correspondence and supporting documents between sites, sponsors, IRBs, and other stakeholders are essential to house in a protocol binder. However, manual workflows associated with downloading and uploading email messages and attached documents hinders efficiency, especially during study startup. By leveraging an email integration within eReg, you can easily send emails, as well as any attached documents to quickly review, and associate them with the appropriate protocols in the system.

eReg-to-eReg Integration

If you are the coordinating center for a multi-site trial, you can ease regulatory burden not only across your organization, but across participating sites through the Advarra eReg-to-eReg integration. When coordinating multi-site trials using Advarra eReg, the sponsor or coordinating center can house their own documents related to studies and the files of all participating sites, organizing everything in a site-specific folder structure. Facilitated by a multi-site protocol connection, the coordinating site can request documents from the participating site, and the participating site can easily send the appropriate documents as requested.

Sponsor/ Contract Research Organization (CRO) Systems Integration

These integrations ensure sites to compliantly and confidently execute the protocol, empower and inform study participants, and efficiently manage and monitor studies within one intuitive platform.

The challenge for sites and sponsors is ensuring these interfaces connect with one another and with technology across the enterprise. If they do not, they may encounter duplicate or disconnected data, affecting outcomes and efficiency.

Advarra eReg-eIRB Integrations

To achieve connectivity and support clean data, optimized workflows, and compliance, a unified eReg integration is essential. Advarra eReg provides integrated protocol, staff, and institution documentation to streamline regulatory process and enhance compliance. Advarra offers two system options:

• eIRB integration: Documents shared between your IRB and organization are an essential component of your long-term binder storage and are often updated and routed throughout the study’s life cycle. By utilizing integrations from both central and local eIRB systems to your eReg system, you can reduce manual effort and increase compliance by syncing important documents via central intake processes.
• CIRBI integration: In addition, Advarra eReg supports integration with Advarra’s Center for IRB Intelligence (CIRBI) Platform and connections with your local eIRB system. With this IRB integration, all approved documents are immediately accessible for your regulatory and clinical staff in eReg to take the necessary action. This also allows you to decrease time and effort needed to manually download documents from an external system and upload them into your regulatory binder across your institution’s research portfolio.

ROI Benefits of CIRBI Integration

By eliminating manual document management, trial teams can save upwards of five minutes per document.^[1] With an average of 200 documents per protocol that would leverage this type of integration, that amounts to 16 hours saved per protocol. For sites with a significant research volume, this can amount to tens or hundreds of thousands of dollars in full time exempt (FTE) savings over time.

The time savings are generated by the automation behind Advarra’s CIRBI Platform, which enables real-time communication among sponsors/CROs, research sites, study staff, and IRB members. For example, following the initial submission, all IRB-required documentation and submissions are readily available in the CIRBI Platform, and you’ll receive instant notification of and access to IRB correspondence and the ability to view the original regulatory documents 24/7.

With the CIRBI integration, you can accelerate your clinical trial’s startup phase and be confident in the quality of your document data throughout the course of the trial as you save valuable staff time.

^[1] According to Advarra data based on a top 10 biopharmaceutical company

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