Reusable study assets
Build on work already done.
The team drew on a library of data collection forms and components developed over more than a decade of using CDP.
An established starting point for new studies.
All case studiesWhen every day mattered,
Case study · COVID-19 testing
When every day mattered,
experience made the difference.
A leading diagnostics company built on a decade of experience with Clinical Discovery Platform to launch urgent studies and support emergency use authorizations for COVID-19 testing.
Explore the responseThe challenge
Clinical studies
could not wait.
As COVID-19 spread in early 2020, the client needed to move quickly to make rapid, affordable testing available. Its clinical data management team was tasked with developing and deploying several studies in days or weeks, when the work would ordinarily take months.
The studies would support Emergency Use Authorization (EUA) submissions to the U.S. Food and Drug Administration. Data had to be collected, cleaned and prepared for meaningful statistical analysis while the team worked around the clock.
The team’s advantage was a platform it knew, processes it trusted, and a partnership built over more than a decade.
The approach
The foundation
was already in place.
The client’s experienced team had refined its processes around CDP. When the pace of research changed, it could put that accumulated knowledge and investment to work.
Development and testing
Prepare each study for use.
CDP’s development and testing tools, with separate testing, training and production environments, supported the rapid rollout.
Familiar tools for an experienced team.
A platform shaped around the client
Support their way of working.
Client-specific enhancements aligned CDP with the team’s requirements and the processes it had refined over years of research.
Technology that supported established processes.
People who knew the work.
A team ready to help.
Simplified Clinical worked alongside the client as it launched multiple studies in the United States and Europe. The client’s expertise, established workflows and close collaboration with our support team helped turn an urgent plan into active research.
The outcome
Clinical data behind
an extraordinary response.
Multiple studies were launched, and the resulting data was collected, cleaned and made available for statistical analysis. That work helped the client obtain emergency use authorizations for COVID-19 testing on an accelerated timeline.
The value of CDP extended beyond the software: years of reusable study assets, tailored capabilities and shared experience helped the team respond when the need was greatest.
Follow the testing-program milestonesTimeline to success
From urgent need
to wider access.
Milestones from the client’s wider COVID-19 testing program, from the first emergency use authorizations in March 2020 to expanded access at home and abroad in June 2021.
Point-of-care and molecular testing
Our client received emergency use authorization (EUA) from the FDA for its first point-of-care test. The compact test delivered a positive result in five minutes and a negative result in 13 minutes. The client also received EUA for a molecular COVID-19 test that month.
A new antibody test
The client received FDA EUA for its third COVID-19 test, an antibody test that detects IgG antibodies to SARS-CoV-2.
Two more diagnostic platforms
Two additional EUAs expanded the client’s COVID-19 testing capabilities across two more of its diagnostic platforms.
Portable, accessible antigen testing
The FDA granted EUA for the client’s portable COVID-19 antigen test. About the size of a credit card, the $5 test delivered results in 15 minutes and worked with a complementary mobile app, expanding access to rapid testing.
Laboratory antibody testing
The client received FDA EUA for a laboratory-based COVID-19 IgM antibody blood test, adding another testing option to its diagnostics program.
Guided testing at home
The client’s rapid antigen COVID-19 test received FDA EUA for prescription use at home through a virtually guided online service. The at-home test provided results in 20 minutes.
150 million tests delivered
The client fulfilled the U.S. federal government’s order for 150 million COVID-19 antigen tests. The Department of Health and Human Services distributed the tests to states, territories, and organizations including nursing homes, assisted living facilities, home health and hospice agencies, historically Black colleges and universities, and the Indian Health Service.
Self-testing expands in Europe
The client received CE marking for over-the-counter sale of its COVID-19 antigen self-test in Europe. The authorization covered use by adults and children, with or without symptoms, extending access to testing at home.
A platform and a partnership
What could your team accomplish with the right foundation?
Tell us about your priorities, your established processes, and the challenges ahead. Together, we’ll explore how CDP and our team can help.