Exploring New Technology Integrations to Make Research Compliance Altogether Better

Ryan Monte
Senior Product Marketing Manager, Forte
August 11th, 2020

When Advarra and Forte joined forces less than one year ago, we wasted no time in embracing the “altogether better” approach. While Advarra IRB, IBC, and regulatory compliance consulting and Forte technology and services are widely used throughout the clinical research industry, our goal from the start was to leverage our expertise to do even more to move research forward. This meant establishing Advarra not just as a provider of services, consulting, and technology, but as a true partner to stakeholders across the industry: sites, sponsors, CROs, and, most importantly, patients.

Inefficiency within the study activation process is a common frustration throughout the industry. Extended startup timelines negatively affect all stakeholders mentioned above, resulting in significant revenue loss for sites and sponsors, and the delay of meaningful treatments from reaching those who need them most. As protocols become more complex and recruitment more targeted, streamlining the activation process is key to a successful clinical trial.

Two essential, closely related pieces of the activation process are the maintenance of regulatory binders and the management of IRB documentation. As the research community’s preferred independent IRB, Advarra works with more than 3,200 institutions to protect research participants and reinforce high-integrity study conduct and regulatory compliance. Advarra’s Center for IRB Intelligence (CIRBI) Platform provides a 21 CFR Part 11 compliant, electronic IRB management platform to enable real-time communication among sponsors/CROs, research sites, study staff, and IRB members. The end result is greater transparency, accessibility, and quality oversight for clinical research programs.

Likewise, Forte eReg streamlines institutional regulatory management, providing enterprise-level workflows to save staff time and improve compliance at academic institutions managing a large volume of research. The system was built in collaboration with some of the most prestigious institutions in the US, ensuring a “site-first” mentality that addresses major challenges in institutional regulatory workflows. Some key features influenced by our collaborators include enterprise-level functionality like master delegation of authority and templated protocol creation, as well as remote monitoring and electronic signatures that have helped eReg customers throughout the COVID-19 pandemic.

See eReg in action: Schedule a demo for your site

Both Forte eReg and CIRBI are already trusted by academic medical centers, cancer centers, and health systems throughout the industry to improve compliance and study activation timelines. As part of our “altogether better” approach, our goal was to streamline this process even further.

Our most recent eReg update provides unprecedented integration between the two systems, automatically uploading documents and syncing data from Advarra’s CIRBI platform to Forte

eReg. This eliminates the need for regulatory staff to download documents from the CIRBI platform and upload to eReg. Instead, the documents are delivered directly to the corresponding protocol inbox within the eReg system, allowing staff to quickly review and file. The resulting workflow provides significant time savings for regulatory teams, and improves compliance by eliminating the opportunity for errors during the download/upload process.

Looking Ahead

Moving forward, we will continue to work with our collaborators to improve the study activation and trial management process. As sites continue to depend on remote regulatory workflows to navigate the pandemic, and as those workflows become part of the “new normal” within research, we’re looking forward to building new efficiencies within the system. Creating seamless integrations between eReg and other enterprise systems will be vital for institutions to save staff time and keep their research moving forward. And as the research ecosystem becomes more connected between sites, sponsors, and CROs, we’re committed to fostering those connections while ensuring our customers have the ability to successfully manage their own investigator-initiated trials as well. Through our collaborative approach, we will continue to take a site- and patient-focused approach to make research altogether better.

Learn more today about Advarra IRB services and the CIRBI platform. You can also request a personalized Forte eReg demo for your site, focused on your institutional goals.