The processes necessary to support regulatory compliance require valuable time and resources within a clinical research institution. Regulatory tasks in particular require frequent coordination between multiple roles and stakeholders to be efficient and successful. Those same workflows can be applied when referring to eRegulatory systems. Direct communication and integration between key operating systems like email, local and central IRBs, Clinical Trial Management Systems, and other eRegulatory instances all contribute to a more efficient and compliant trial.
Email Integration – Accelerate Study Start Up
Correspondence and supporting documents between 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 start up. By leveraging an email integration with your eRegulatory system, you can easily save correspondence (the emails themselves) as well as any attached documents to quickly review and associate them with the appropriate protocols in the system.
The industry’s most integrated eRegulatory system, Advarra eReg, allows you to seamlessly upload documents by utilizing unique email addresses for each protocol binder. For example, imagine a regulatory manager or coordinator receives a protocol update or important correspondence from the IRB or sponsor via email that was necessary to house in the protocol binder. Rather than having to download and then manually upload the information into the system, they’re now able to simply forward that email along or better yet, cc or bcc the eReg system to capture correspondence and attachments as you are working in your email. Once complete, your correspondence and attachments are stored in the protocol specific to your communication for easy long-term filing or additional routing. This not only eases the day-to-day file management burden for your staff but is especially impactful when applied to all studies across the organization.
IRB Integration – Increase Compliance while Reducing Effort
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 lifecycle of a study. By utilizing integrations from both central and local eIRB systems to your eRegulatory system, you can reduce manual effort and increase compliance by syncing important documents via central intake processes.
Advarra eReg supports integration with Advarra’s Center for IRB Intelligence (CIRBI) Platform. In addition, Advarra eReg supports connections with your local eIRB system. With this IRB integration, all approved documents can be 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 download documents from an external system and upload them into your regulatory binder across your institution’s research portfolio, maximizing time and effort saved.
Register for our upcoming webinar, Creating an Integrated Approach to Regulatory Management at Your Institution to learn more about how integrated systems and centralized processes expedite regulatory workflows.
Clinical Trial Management Systems Integration – Accelerate Study Start Up
An organization’s clinical trial management system (CTMS) is often the source of truth for all protocol and participant information. Minimize duplicate effort within regulatory workflows through integration with Advarra’s OnCore Research Enterprise System by pulling CTMS data related to protocols, contacts, and organizations, into a new protocol in eReg to support accurate and efficient binder building during study start up. This integration allows for organizations to level-up their technological workflows including streamlining the administration of staff training and delegation of authority. Connecting your CTMS and eReg systems through intentional, purpose-built workflows ensures your processes remain in sync across systems and match real-life workflows without the parameters of the applications.
eReg to eReg Integration – Efficiently Coordinate Multi-Site Trials
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 by leveraging the Advarra eReg-to-eReg integration. When coordinating multi-site trials using Advarra eReg, the sponsor or coordinating center can house not only their own documents related to studies, but also the site files of all participating sites, structured 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.
While significant efficiencies occur through the eReg-to-eReg integration, for those participating sites operating on paper or not using an electronic system, the participating site can log into the coordinating site’s instance of eReg to upload their documents into the regulatory binder. With a simple review and routing workflow, the coordinating site can efficiently manage protocol documents across multiple sites to ensure study compliance, and effectively manage essential correspondence, amendments, and more.
Just as communication and coordination amongst regulatory staff, principal investigators, sponsors, and other stakeholders improves the efficiency of a trial, so does communication amongst your technology systems. 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. Join us on Thursday, January 21 at 1 pm ET to explore how integrations play a key role in navigating our new research landscape in our upcoming webinar, ‘Creating an Integrated Approach to Regulatory Management at Your Institution.’