CASE STUDY

Challenges

Theis client began tracking the coronavirus outbreak at
the end of 2019 and into early 2020. In February, they
held an internal meeting to discuss a 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 that they needed to launch several accelerated
clinical studies designed to obtain Emergency Use
Authorizations (EUAs) from the FDA to provide
affordable, accessible, and efficient testing methods for
both public and private use.

Solutions Implemented

The client’s Clinical Data Management team was tasked
with developing and deploying a series of studies in a
matter of weeks, when the timeline typically takes
months.

This well-trained and experienced team leaned on its
finely honed processes built on our Clinical Discovery
Platform (CDP). They had relied on CDP for over a
decade, with the platform customized to support their
specific needs. By strategically partnering with
Simplified Clinicals support team, this client made their
around-the-clock work pay off.

Multiple new studies were quickly launched in the US as
well as the EU, and the critically important EUA data was
collected, cleaned, and made available for meaningful
statistical analysis – a feat which ultimately helped
obtain FDA approvals needed before competitors.

Results

Many of the record-setting EUAs and other achievements of
this client were built on our Clinical Discovery Platform. They
were able to immediately leverage some of their most trusted
tools over the past 10 years, such as: a library of reusable data
collection forms; intuitive development and testing tool kit;
redundant testing, training, and production user
environments; customized system enhancements.

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 solutions to market around the
world … in record time. Testing will continue to be part of
local, national, and global COVID-19 recovery strategies.

About Us

Simplified Clinical pioneers clinical data management,
supported by a strategic partnership with Microsoft
Azure’s Cloud for Healthcare. Our mission is to help
clients accelerate scientific discovery and regulatory
approval to improve the lives of patients worldwide.

As a leader in clinical trial data management software
(CTMS) and Al, our vision is to help you help others by
maximizing interoperability to unlock the potentials
within your clinical research.

We continue to shape the evolution of clinical trials by
accelerating data collection and analysis with an intense
commitment to Zero Data Entry (ZDE)™, that benefits
patients, sponsors, investigators, and site coordinators.