Non-Traditional Clinical Trial Sites Powered by the Curebase System Support Emergency Use Authorization of New Rapid COVID-19 Test

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.”    Tweet this

“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.”

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About Curebase
Curebase is reinventing decentralized clinical trials to help the vast majority of potential patients that currently cannot access clinical research. Our vision is that any patient, no matter where they are located, should be able to participate in clinical trials at home and with their own doctors. This is made possible through a unique suite of tools Curebase’s has designed to engage patients in clinical trials across all settings, be it at home, at their local clinic, or other places in their community.  

This starts with Curebase’s leading decentralized clinical trial software platform that is an all-in-one, purpose built eClinical software system, with every tool needed to manage and collect data for decentralized clinical trials. This includes ePRO, eCOA, eConsent, Telemedicine, and much more. Curebase also offers a virtual research site, complete with virtual investigators, research coordinators, mobile nursing, and other healthcare staff that administer care to patients where convenient for them, just like any other research site, but with the ability to stand up anywhere and with greater patient convenience and reach. Notably, Curebase is the pioneer of the “BYOP” or Bring Your Own Physician model, allowing patients to use their own doctors to participate in clinical trials. 

We are reinventing a $45B market, enabling drug and device companies to increase the volume, quality, and speed of data collection regardless of patients’ physical location. COVID-19 tailwinds have created massive demand for telemedicine and home-based trials, with two new FDA guidance letters and industry-wide adoption of remote remote research that will only accelerate in the years to come. You can learn more about Curebase and our next stage of growth in Crunchbase, Fierce Biotech, and MedCity News!

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Media Contact:

Shawn Malloy

media@curebase.com

315-882-5310

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SOURCE Business Wire

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