As we begin to emerge from the challenges of the COVID-19 pandemic, it’s clear that the post-pandemic landscape differs from the one to which we have been accustomed. Sites and life sciences companies have quickly adopted remote workflows and other clinical and operational transformations to keep trials moving, and these changes are sure to inform our “new normal” as we look forward.
Speaking with our Onsemble Community members working in the regulatory space, a common change we have heard over the past year is an increased reliance on technology. “The Advarra eReg system has helped to keep us functioning during our shelter-in-place order,” said Kasha Donahue, Regulatory Manager at the Karmanos Cancer Institute. “It 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 over the past year 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 life sciences companies, 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. Another key component that has become especially relevant in the current research landscape, is multi-site regulatory management. Our Advarra eRegulatory Management System collaborators identified this as a priority early in our development process, and in 2020 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 Advarra 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, Advarra eReg can help create more efficient, compliant workflows for your regulatory team. Reach out to request a demo tailored to your specific institutional needs.