eClinical Technology and Industy News

Emulate Signs Collaborative Agreement with the FDA to Apply Lung-Chip to Evaluate Safety of COVID-19 Vaccines and Protective Immunity Against SARS-CoV-2

Excerpt from the Press Release:

BOSTON–(BUSINESS WIRE)–Emulate, Inc. announced today that it has entered into a Cooperative Research and Development Agreement (CRADA) with the U.S. Food and Drug Administration (FDA) to enable multiple studies across FDA offices in priority research areas, including programs to evaluate COVID-19 vaccines and understand human immune response against SARS-CoV-2, the virus that causes COVID-19.

Under the CRADA, the FDA will use a range of Organ-Chips from Emulate to study the safety, efficacy, and mechanisms of drugs regulated by the FDA. The initial studies use Organ-Chips—which are able to recreate the natural physiology of specific human tissues and organs—in areas where conventional cell culture and animal-based testing methods have limitations in reflecting human biology and disease mechanisms that are not yet understood, such as Alzheimer’s disease and COVID-19. This new CRADA agreement follows the successful completion of the first Emulate CRADA with the FDA initiated in 2017 that focused on toxicity studies using the Liver-Chip.

Click the button below to continue reading the Press Release:

Continue Reading The Press Release

Discover What Sets TrialStat Apart From Ordinary EDC Platforms

Click the image or button below to explore our eClinical Suite Platform and discover what sets TrialStat apart from competing EDC platforms.

Request Your Demo Today!

From rapid database build through database lock, we deliver consistent quality on-time and on-budget. Ready to upgrade your eClinical toolkit?

Archives