Free Research Compliance Resources During COVID-19 Crisis

March 26, 2020

Applied Clinical Trials

Advarra has announced the availability of free resources to support and enable the clinical research community and ongoing research during the coronavirus disease (COVID-19) crisis. This includes complimentary transfer of IRB oversight, access to a new version of Forte eRegulatory management software, eReg Lite, and a dedicated "Ask Advarra" resource for rapid guidance on emerging issues impacted by COVID-19.

"Advarra has been reviewing more COVID-19 research since the beginning with priority reviews and reduced fees, but we wanted to do more," said Robann Cunningham, Chief Commercial Officer at Advarra. "COVID-19 has not adversely impacted Advarra's business thanks to our virtual capabilities, and we feel it is our responsibility to give back since we have the expertise, depth of resources, and technology to keep research moving forward during these challenging times."

Transfer of IRB oversight

Currently imposed restrictions may limit the ability of local IRBs to appropriately oversee ongoing research. To prevent these local IRB challenges from leading to unnecessary study closures, Advarra is offering free transfer of IRB oversight through the end of 2020. The Advarra IRB will review the transferred studies and sites and continue as the IRB of record until the local IRB is prepared to re-take the studies.

eReg lite 

To help streamline remote workflows for researchers and enable remote access to sponsors and CROs, Advarra is offering its research technology customers a free version of Forte eReg software-eReg Lite-for the remainder of 2020. eReg Lite provides many features that enable virtual telework and collaboration such as remote monitoring capabilities, electronic signatures, and delegation of authority. The software can be implemented quickly and also integrates with the OnCore Enterprise Research System.

Customized support and online resources 

At the onset of the crisis Advarra launched a free online forum, Ask Advarra, to provide direct and customized responses to COVID-19 inquiries within one business day. After receiving hundreds of questions, Advarra began to publicly post the most frequently asked responses to the Coronavirus Guidance webpage of FAQs, and research professionals can register to receive email alerts whenever new information is published.

Other virtual support and consulting 

The rapidly changing clinical trial landscape has resulted in a dynamic environment for sponsors, CROs, and sites. Advarra experts are ready to assist research colleagues with a variety of capabilities, many of which can be offered remotely, including audits of vendors and eTMF platforms, virtual document support in the form of QC/QA of study reports and regulatory filing documents, as well as interim staffing for local IRBs and clinical trial offices.

Advarra is proud to partner with the research community to fight COVID-19. The organization remains vigilant in its mission to provide thought leadership and keep researchers informed as the community navigates the clinical trial landscape together during this crisis.