Non-Traditional Clinical Trial Sites Powered by the Curebase System Support Emergency Use Authorization of New Rapid COVID-19 Test
December 15, 2020
SAN FRANCISCO--(BUSINESS WIRE)--Curebase, a company committed to democratizing access to clinical studies, today announced that Luminostics utilized the company’s virtual site solution to power clinical studies for its Clip COVID Rapid Antigen Test, which was granted Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) on December 7, 2020. For this study, Curebase was able to convert drive-through COVID-19 testing centers into clinical research sites with its unique decentralized clinical trial software platform and virtual site support model, that provided participant screening and consent in real-time while in the safety of their vehicle.
“Running a prospective clinical study in the midst of a pandemic has proven difficult and, for some studies, impossible. Curebase’s product and services allowed us to safely and quickly enroll study participants.”
“Curebase shares in our mission to increase healthcare accessibility and efficiency and by utilizing their platform we were able to rapidly operationalize existing drive-up testing centers as clinical study sites in about two weeks,” said Bala Raja, CEO of Luminostics. “Running a prospective clinical study in the midst of a pandemic has proven difficult and, for some studies, impossible. Curebase’s product and services allowed us to safely and quickly enroll study participants.”
Curebase’s unique web-based system allowed for potential participants to assess their eligibility for the validation study while in their cars waiting for a COVID-19 test. By accessing a specific study website on their own phones, candidates could answer screening questions and consent to participate in the Luminostics study. This high-throughput process was able to be completed without any physical interaction with patients and enabled hundreds of people to be screened in a few weeks.
“Conducting a study like this within a traditional research center would typically require many physical interactions with individuals infected with COVID-19. The Luminostics study demonstrated that the Curebase system can successfully be utilized to activate testing sites essential to generating data in support of FDA submissions and, ultimately, product use authorizations,” said Tom Lemberg, CEO and Founder of Curebase. “The Curebase system allows any healthcare provider to contribute to clinical research. We believe the successful initiative demonstrates how we can turn virtually any non-traditional location, such as a COVID drive-through testing center, into a research site.”
The Curebase system is being used by physicians from practices of all sizes to conduct clinical research, including private practices, independent clinics, and large academic research sites. Access through an easy-to-use and secure web-based portal makes it possible for healthcare professionals to rapidly set-up and manage clinical research programs. The Curebase system is coupled with a virtual staff augmentation model that enables physicians to focus on treating patients while Curebase handles many of the time-consuming tasks traditionally involved in clinical research, including consenting patients, managing/scheduling and paperwork logistics.
With Luminostics successfully securing an EUA for their Clip COVID Rapid Antigen Test, Curebase hopes to expand the use of drive-through testing sites across the country in an effort to help researchers respond more quickly to the pandemic.
Lemberg added, “Our hope is that we can truly make clinical research accessible to anyone, and the recent EUA of the Luminostics test gives us confidence that regulators think so as well.”
At Curebase, our mission is to bring quality medical innovations to patients faster and improve human wellbeing through more efficient clinical studies. We are proving that clinical research can be radically accelerated if we empower physicians everywhere to enroll patients in the communities where they live. By applying cutting edge clinical software and remote study management techniques to the problem, we are reinventing clinical trials and research from the ground up.