Case Study: Large Field-based Study in Africa
OVERVIEW:
Project Highlights:
A pivotal Phase III clinical trial for a
promising anti-TB vaccine. The
5 Countries in Africa.
project involves a diverse spectrum
of stakeholders - Funding Agency,
~ 7,000 subjects across 11 sites.
Sponsor,
Local
Non-profit
Organization, CRO, sites and
multiple analytical laboratories.
CHALLENGES:
• Field-based study
- remote
locations of sites and low
internet connectivity.
• Country to country & site to site
variation in source data capture
practices
could
lead
to
incoherent monitoring and data
inconsistencies.
• Multiple
stakeholders
-
possibility of duplication of effort
and communication gaps.
SOLUTION
OUTCOME
Use of customized eSource
Standardized source data capture.
integrated with eCRF.
Improvisation to use IWRS, eSource
Enablement of randomization, source data capture & eCRF
and eCRF in a fully-integrated
completion even at locations with no / low internet connectivity.
unique, first in industry ‘offline’ mode.
Increased subject recruitment speed and timely data capture.
Collaborative environment of the
Seamless study conduct, smooth communication between
Wide-Angle-Insights platform with
stakeholders and complete transparency.
automated event histories.
Integrated pharmacovigilance
Sites need to enter SAE data only once, thus reducing data
database.
entry effort and necessity of reconciliation.
Integrated medical review platform.
Real-time safety data review & timely signal detection,
adjudication, correlation, resolution & management.
Inbuilt Risk Engine that facilitates
Enhanced oversight and implementation of mitigation
real-time Risk Management.
strategies.
Customizable, real-time updated
Efficient project management and timely course correction.
dashboards and reports.
14-Jun-2020