Simplified Clinical Data Systems Accelerates
FDA Approvals for Covid-19 Testing

In the Face of a Pandemic: Leading U.S. Medical Device and Healthcare Company Uses Simplified Clinical Data Systems to Accelerate FDA Approvals for COVID-19 Testing.

The Challenge

Help one of the world’s top medical device and healthcare companies deliver rapid, cost-effective, and accessible testing to help mitigate the spread of the coronavirus (COVID-19).

The Outcome

Using Simplified’s Clinical Discovery Platform (CDP), their client was able to quickly develop and deploy several clinical studies leading to Food & Drug Administration (FDA) Emergency Use Authorization (EUA) in record time.

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 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.

Timeline to Success: Emergency Use Authorizations

In fewer than 3 weeks, their client received emergency use authorization (EUA) from the FDA for its first point of care test. This was a valuable development due to its size (comparable to a small toaster) and rapid results: 5-minute positive, 13-minute negative. They also received EUA for a molecular COVID-19 test in March.

The client was awarded EUA from the FDA for its third COVID-19 test, an antibody test that helps detect the IgG antibody to SARS-CoV-2.

The Client received two (2) additional EUAs running on two additional company-owned platforms.

After only five months, another EUA was granted from the FDA for their $5.00/15-minute, portable COVID-19 antigen test, compatible with their complementary mobile app. This test (just the size of a credit card) was heralded as a game-changer by news, media, and science outlets because of its speed, massive scale, low cost, and a compatible app, which gives tens of millions of people access to rapid testing.

After announcing this phenomenal accomplishment, their client’s company stock went up nearly +9% (~$18 Billion) in one day. Additionally, the stock prices of their major competitors in the COVID-19 testing space took a big hit. At least $22 billion in market value was lost across more than a dozen competitors.

The wins kept coming for their client — and more importantly, the world and its citizens — when in mid-fall, they received EUA from the FDA for a lab-based COVID-19 IgM antibody blood test.

Just 10 months after launching its first clinical trials, the client’s rapid antigen COVID-19 test received EUA from the FDA for use at home with a prescription through a virtually guided online service. The first of its kind, this at-home, virtually guided rapid test, provides results in just 20 minutes.

Client delivered more than 400 million COVID-19 tests since the pandemic began in early 2020 and 300 million in the fourth quarter of 2020 alone.

A Huge Win/Win. Their client fulfilled the federal government’s order of 150,000,000 COVID-19 Ag. These rapid tests were distributed through the Department of Health and Human Services (HHS) to states, territories and targeted entities, such as nursing homes, assisted living facilities, home health and hospice agencies, historically black colleges and universities (HBCUs), and the Indian Health Service.

At home and abroad, the client got CE mark approval to market the Panbio COVID-19 test for over-the-counter use. European approval covers the direct-to-consumer sale of the Panbio COVID-19 antigen self-test for detecting the SARS-CoV-2 virus in adults and children both with or without symptoms.

Feature-Rich, Compliant Software Makes a Difference

Many of the record-setting EUAs and other achievements of our client were built on the backbone of Simplified’s Clinical Discovery Platform. The client leveraged some of their most trusted tools like a library of reusable data collection forms and components created over the past 10 years, intuitive development and testing tool kit, as well as redundant testing, training, and production user environments.… along with several customized system enhancements to meet their exact needs.

Millions Reached in Record Time

What this client’s data management team pulled off is nothing short of a miracle that has helped tens of millions. Simplified Clinical could not be more proud of the role their SaaS and dedicated support team played in helping to bring these critical pandemic-fighting weapons to market around the world… in record time.

  • Hospitals
  • Primary care providers
  • Frontline health care workers
  • Educational institutions
  • Corporate organizations
  • Millions of individuals and families

A Job Well Done Doesn’t Stop Here

Testing will continue to be part of our local, national, and global short- and long-term COVID-19 recovery strategy — and Simplified Clinical will continue to be at the forefront of this innovation. Our job is never done.

Results, Simplified

Simplified Clinical provides world-class clinical trial software as a service (SaaS) to medical device companies, life sciences, and biopharmaceutical leaders, universities, and teaching hospitals. Working alongside sponsors, CROs, consortiums, and consultants, Simplified implements a standard platform to maximize trial results, and their CDP is customizable for maximum efficiency when collecting and reporting on integrated clinical trial data.

Contact us today to learn how we can help you help others.

Accelerate Your Discovery

Learn how we can move your approvals forward, faster.

@ 2021 Simplified Clinical Data Systems, LLC - ALL Rights Reserved.

Page Designed & Developed by DARCI Creative