Applied Clinical Trials
Advarra, the provider of institutional review board (IRB), institutional biosafety committee (IBC), research quality and compliance consulting services, and technology, shared progress made by customers utilizing the company’s products and services to keep research moving forward during the COVID-19 pandemic. Institutions from across the clinical research industry leverage Advarra technology both for day-to-day management of research operations and to manage the influx of new COVID-19 trials aimed at prevention and treatment of the disease.
To fast track the activation of a large-scale COVID-19 trial, Henry Ford Health System (HFHS) chose Advarra’s electronic data capture system, Forte EDC. Advarra is working closely with HFHS to implement and validate Forte EDC on an accelerated two-week timeline. Additionally, HFHS will leverage Advarra’s EDC Study Design Service to build the necessary components within Forte EDC. The service will allow HFHS to reduce their administrative burden and open the trial sooner.
“In this unprecedented time, research is crucial to better understanding this virus,” said Dan McLaren, Manager, Clinical Research Informatics Services at Henry Ford Health System. “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.”
In addition, Advarra’s eRegulatory management system, Forte eReg, is used by leading academic institutions across the industry to ensure regulatory compliance and efficiency. With remote monitoring, electronic signatures, and document management, the system is ideal for organizations looking to manage new workflows from telework environments during the COVID-19 crisis. The ability to maintain progress on both COVID-19 and day-to-day studies is crucial during the pandemic, and technology plays an important role.
“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,” said Kasha Donahue, Regulatory Manager at the Karmanos Cancer Institute. “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.”
For academic institutions, cancer centers, health systems, and community-based sites in need of an eRegulatory management system, Advarra is also offering eReg Lite, a 21 CFR Part 11-compliant solution featuring remote monitoring capabilities, electronic signatures, delegation of authority, and more. The system is free to use, and is designed specifically to ensure regulatory compliance and efficiency in an increasingly remote environment. And for institutions using Forte technology, Advarra’s Business Operations Services (BOS) team is offering free study calendar builds with a one-day turnaround time for all COVID-19-related studies.
In addition, Advarra worked with Yale University to identify a approach to study activation, monitoring, and reporting for COVID-19 studies. The process leveraged Advarra’s OnCore Enterprise Research System and the Forte Insights analytics platform to open trials and accrue patients quickly. The stakeholders then shared their work within the Onsemble customer community to help ensure efficient COVID-19 trials not just at Yale, but across the industry.
“While the pandemic has brought unprecedented challenges for the research community, it has also brought us together,” said James Wurdeman, Chief Product Officer at Advarra. “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.”