Case Study: COVID-19 Australia Study
Project Highlights:
~ 3,500 subjects across 10 sites.
Largest Australia-only COVID-19 clinical trial till date.
OVERVIEW:
CHALLENGES:
In the light of the fast-spreading
• Set-up and activation of clinical trial systems,
COVID-19 pandemic, one of the
i.e. eCRF, ePRO / eCOA, pharmacovigilance &
largest vaccine manufacturers in
IWRS could take a minimum of 8 to 10 weeks.
the world believed that a
• It was necessary to minimize in-person follow-
prophylactic vaccine currently
up hospital visits without compromising on the
under development for another
frequency and volume of data collected.
indication could possibly offer
• Involvement of multiple stakeholders - Sponsor,
protection to high-risk groups.
Australia-based CRO for local Clinical
The need was to start the trial
Operations and Data Services CRO - could lead
as soon as possible to ensure
to duplication of effort.
early availability.
SOLUTION
OUTCOME
The need for a quickly configurable
All the integrated modules i.e. eCRF, ePRO / eCOA, IWRS,
integrated platform was met by Wide-
pharmacovigilance & medical review were activated in record
Angle-Insights, with its modular
time, enabling initiation of subject recruitment within 3
architecture, inbuilt intuitive algorithms
weeks of protocol finalization. This is inclusive of time
and artificial intelligence.
required for team training.
Collaborative environment of the
Seamless study conduct, smooth communication between
Wide-Angle-Insights platform with
stakeholders and complete transparency.
automated event histories.
ePRO / eCOA within the mobile app.
Drastically reduced the number of site visits by subjects.
Data completion prompts and
Ensured timely data capture.
notifications in the mobile app.
Integrated pharmacovigilance database
Sites needed to enter SAE data only once, thus reducing
– Single Source of Truth +
data entry effort and necessity of reconciliation.
Integrated medical review platform.
Facilitated real time safety data review and enabled timely
signal detection, adjudication, correlation, resolution
and management.
Inbuilt Risk Engine that facilitates real-
Enhanced oversight and implementation of mitigation
time Risk Management.
strategies.
Customizable, real-time updated
Efficient project management and timely course correction.
dashboards and reports.
14-Jun-2020