As the clinical research community works to navigate the challenges of COVID-19, it’s clear that the post-pandemic landscape will differ from the one familiar to us today. Sites and sponsors are quickly adopting remote workflows and other clinical and operational transformations to keep trials moving, and these changes are sure to inform our “new normal” when we emerge from the pandemic.
Speaking with our Onsemble Community members working in the regulatory space, a common change we have heard is an increased reliance on technology. “The eReg system has helped to keep us functioning during our shelter-in-place order,” said Kasha Donahue, Regulatory Manager at the Karmanos Cancer Institute. “[Forte eReg] has ensured that we avoid disruption to our regulatory processes, keeping our research on track.” While many sites were already moving toward these systems, the rapid shift to remote work has highlighted the inefficiency of antiquated methods such as paper binders and on-site monitoring. In the current clinical research environment, reliance on manual processes can bring regulatory management to a halt, while an electronic system can positively affect study activation timelines, resource planning, leadership visibility and even regulatory compliance itself.
As we move forward, it’s crucial to continue our push toward creating new efficiencies and fostering a more streamlined, connected clinical research environment. Adopting new technology to replace manual processes will be key, but as a research community, we can do more. While we hope to avoid hurdles as immense as the COVID-19 pandemic, we should proactively prepare for new challenges. For sites and sponsors, especially those managing a large volume of clinical research, working toward a shared vision for managing data such as trial master files (TMFs) and investigator site files (ISFs) is vital. When we launched our Trial Data Exchange (TDX) initiative in 2018, we understood the need for the industry to come together to embrace unified standards for sharing regulatory, operational and clinical data. But we had no idea that COVID-19 would highlight the need for these standards so soon.
A key component of TDX, and one that has become especially relevant in the current research landscape, is multi-site regulatory management. Our Forte eRegulatory Management System collaborators identified this as a priority early in our development process, and this year we released new functionality to allow a sponsor/coordinating center to seamlessly exchange documents with participating sites. The workflow accommodates all sites, whether or not both use the Forte eReg system. However, with eReg systems connecting at the site and sponsor level, they unlock unprecedented efficiencies, allowing them to coordinate or participate in a trial without leaving their systems.
We expect these new workflows to soon be commonplace among eReg customer institutions, with several multi-site studies already in their early stages. And while eReg-to-eReg system integration is a significant step toward the connected clinical research ecosystem we see as vital in the post-COVID-19 landscape, there’s still more work to be done. As mentioned above, research sites and industry sponsors/CROs must still work to bridge the gap and standardize data related to trial master files and investigator site files. In the future, we hope to continue our work with all stakeholders to make this goal a reality.
If your site conducts or participates in multi-site trials, Forte eReg can help create more efficient, compliant workflows for your regulatory team. Reach out to request a demo tailored to your specific institutional needs. If your organization needs to quickly adopt remote workflows during the COVID-19 crisis, get our free eReg Lite solution to ensure regulatory compliance and safety of your staff and participants.