WHEN SPEED REALLY, REALLY MATTERS
Their client began tracking the coronavirus outbreak at the end of 2019 and into early 2020. In February, they held an internal meeting to discuss its plan of action as the virus began spreading rapidly and was introduced to the U.S. On March 11, 2020, the World Health Organization declared the COVID-19 outbreak a pandemic. It became clear to them that they needed to launch several clinical studies designed to obtain Emergency Use Authorizations (EUAs) from the FDA to provide affordable, accessible, and efficient testing methods for public and private use.
TO ANSWER THE CALL IS TO PUT IT LIGHTLY
The client’s Clinical Data Management team was tasked with developing and deploying a series of studies in a matter of days/weeks — when they typically take months. Fortunately, this well-trained and experienced team leaned on its finely honed processes built around Simplified’s Clinical Discovery Platform (CDP).
They had relied on CDP for 10+ years having the platform customized to support their specific needs. Working shoulder to shoulder with the support team at Simplified, they made their around-the-clock work pay off.
Multiple new studies were quickly launched in the U.S. and E.U., and the critically important EUA data was collected, cleaned, and made available for meaningful statistical analysis — a feat which ultimately helped obtain the FDA approvals needed before their competitors.