The company reports a number of institutions are harnessing its technologies to advance research related to the virus behind the global pandemic. These teams are leveraging Advarra products and services to manage research operations, and to manage new trials focused on preventing and treating the disease caused by the virus.
Fast-tracking trials
Among those, Henry Ford Health System (HFHS) is using the Forte EDC (electronic data capture) system to fast track activation of a large-scale COVID-19 trial. Advarra and HFHS are partnering to implement and validate the EDC on a two-week timeline.
Additionally, HFHS is using the EDC Study Design Service to build the necessary study components within the Forte EDC. The organization hopes use of the technology will alleviate the administrative burden, enabling them to open the trial sooner.
Dan McLaren, manager of Clinical Research Informatics Services at HFHS, said efforts to accelerate research on COVID-19 can help protect public health.
“In this unprecedented time, research is crucial to better understanding this virus,” he said. “By expediting our technology implementation and offering strategic services, Advarra has enabled us to meet our study activation timelines and begin this critical research as soon as possible.”
Regulatory management
Advarra’s Forte eReg eRegulatory management system is being used by several academic institutions. It enables organizations to implement remote monitoring, electronic signatures, and document management. It also lets users handle new workflows, including telework collaboration, during the COVID-19 crisis.
According to Kasha Donahue, regulatory manager at the Karmanos Cancer Institute, such remote technology is highly useful with the virus necessitating work away from central offices.
“The eReg system has helped to keep us functioning during our shelter-in-place order. Our regulatory staff has remote access to binders and our leadership team has visibility into our studies,” she said. “Also, the ability to electronically sign documents within the system has ensured that we avoid disruption to our regulatory processes, keeping our research on track.”
Additional resources
Advarra also is offering eReg Lite, a 21 CFR Part 11-compliant solution featuring remote monitoring capabilities, electronic signatures, delegation of authority, and other features. The product, offered at no charge, is designed to ensure regulatory compliance and efficiency in increasingly remote environments.
Also, organizations using Forte technology can use the services of the Business Operations Services team. It is offering free study calendar builds with a one-day turnaround time for all COVID-19-related studies.
Advarra has partnered with Yale University to identify a streamlined approach to study activation, monitoring, and reporting for COVID-19 studies. The partnership used the company’s OnCore Enterprise Research System and the Forte Insights analytics platform; stakeholders then shared their work within the Onsemble customer community to help promote efficiency in COVID-19 trials across the industry.
James Wurdeman, Advarra’s chief product officer, said the pandemic has created unprecedented challenges, but it has also brought the industry together.
“We are doing everything we can to support research institutions that are on the front lines of working toward COVID-19 treatments and preventions. We’re proud to help them navigate these difficult times and we will continue to search for new ways to support them moving forward,” he said.
