Case Study: COVID-19 India Study
Project Highlights:
~ 6,000 subjects across 40 sites.
First & till-date largest COVID-19 clinical trial in India.
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
the world believed that a
weeks.
prophylactic vaccine currently
• Considering the highly infectious nature of the
under development for another
disease, face-to-face consenting and paper
indication could possibly offer
Informed Consent Forms & Subject Diaries
protection to high-risk groups. The
would be risky.
need was to start the trial as soon
• It was necessary to minimize in-person follow-
as possible to ensure early
up hospital visits without compromising on the
availability.
frequency and volume of data collected.
SOLUTION
OUTCOME
The need for a quickly configurable
All the integrated modules i.e. eConsent, eCRF, ePRO /
integrated platform was met by Wide-
eCOA, IWRS, pharmacovigilance & medical review were
Angle-Insights, with its modular
activated in record time, enabling initiation of subject
architecture, inbuilt intuitive algorithms
recruitment within 3 weeks of protocol finalization. This
and artificial intelligence.
is inclusive of time required for team training.
Mobile app with eConsent in multiple
This ensured that the consent was provided electronically in
languages.
the preferred language without the need for paper exchange.
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