For many, May is about celebrating mothers, finally putting away the winter wardrobe, and the gateway to summer vacation. However, to those in the clinical research industry, May brings an important, and personal, day each year: Clinical Trials Day, a holiday to recognize all that has been done and all that is to come in the clinical research world.
Celebrated each year on May 20, this year marks the 16th annual Clinical Trials Day. The day was founded to remember James Lind’s findings in 1747 in what was considered the first randomized clinical trial – confirming the suspicion that scurvy could be prevented by consuming citrus fruits. Unknown at the time, this trial provided a basis for future clinical research, and the clinical trial industry wouldn’t be what it is today without Lind’s initial discovery.
Day in and day out, the research community works to inform individual and human health as well as public policy, and this is especially significant now in the midst of COVID-19. During this unparalleled global pandemic, clinical research professionals have been on the front lines providing care to those who need it most, conducting research to find ways to combat COVID-19, and providing support so that critical research can continue. Clinical research continues to drive important insights that relate to COVID-19, including potential treatments, vaccine answers, and social distancing measures to reduce exposure and infection.
Now more than ever, it’s important to recognize and thank those unsung heroes at the focal point of research: research sites and institutions. Sites face new obstacles every day during the pandemic and yet continue to care for patients and participants. Throughout this unprecedented time, Advarra has and will continue to support investigators and research site staff to keep research moving forward.
Below are free offerings available to Advarra’s customer community in support of research recovery efforts. These resources aim to cover a variety of research aspects, ensuring research professionals at sites and elsewhere receive the guidance they need to continue the critical work of improving human health everywhere.
eLearning Module: Restart Your Research
Designed to help study coordinators, research administrators, and other site staff, Advarra’s free eLearning module Restart Your Research: Things to Consider outlines organizational, protocol, and regulatory requirements to keep in mind when developing an action plan for restarting research studies.
eRegulatory System to Support Remote Workflows
With the shift in remote monitoring, many sites are learning how to manage increased focus on remote work and limitations for onsite monitoring. To help, Advarra is offering a free version of Forte eReg, eReg Lite, until the end of 2020. Designed to ensure regulatory compliance and set teams up for success in an increasingly remote environment, eReg Lite is a 21 CFR Part 11 compliant eRegulatory management system featuring remote monitoring capabilities, electronic signatures, delegation of authority, and more. Through remote implementation, validation, and training, site teams have the ability to adopt the system quickly while maintaining regulatory compliance.
Transfer of IRB Oversight to Keep Research Moving Forward
In research, timing is everything. If current human health restrictions limit your IRB’s ability to appropriately oversee ongoing research, consider free transfer of IRB oversight. When restrictions ease, the original IRB of record has the ability to reclaim oversight. Advarra’s transfer of oversight will help sites keep their studies on track for free until the end of 2020.
“Ask Advarra” Forum for Customized Support
There are still many questions regarding COVID-19 and its impact on human subject protections, biosafety, and other research compliance issues. Advarra’s experts are here to help, answering the community’s most pressing research compliance questions and offering advice on addressing the impact of COVID-19 in research. Submit any question – big or small – and receive a response within one business day.
Advarra stands with the research community during COVID-19 and is here to help however we can to support the research recovery. For more information on our free support capabilities, click any of the above links or contact us directly.