Take a brief look at some highlighted features and functionality of OPRA, the risk-based monitoring platform. As always, demonstrations are gladly performed at request. Contact us anytime at info@tritrials.com

1. Brought to you by:
TRI- Where’s the Risk?

2. What is OPRA?
OPRA is the first and only
purpose-built operational platform
of its kind on the market for
Risk-Based Monitoring and
Quality Oversight

3. Cloud based
Data visualization
Statistical analysis
Zero footprint
web client access
CFR compliantAudit trail
User configurable
Activity management
Trend analysis

4. The OPRA log-in screen

5. Logging-in takes us directly to
the Study Dashboard
Each panel represents a key risk
indicator

6. Application Navigation buttons
are on the left- determines
where you go in the system
Data Navigation determines
which study and assessment
point you wish to see

7. Study Dashboard has graph and
country filters
Filtering allows us to see
only the indicators we
want. We can limit the
sites that we see on the
graphs to those for the
countries we choose.

8. We can expand all graphs from
the study dashboard to look at
them and work with them in
more detail

9. Click on a call out icon next to
a site to make an observation
for the site
Observation window allows us
free text for observation made
and associated comments

10. An action can then be made to
accompany the observation.
Assign it to an owner and
assign a completed date
Observations and actions
capabilities are available for all
indicators and at a site level as
well

11. The Study Profile view shows a heat map
of the whole study, or any region or
country in the study
Each site is shown as a
rectangle on the heat map,
colored by risk level

12. Clicking on a country drills down to the
heat map for that country

13. Study profile has filtering capability to
focus on individual indicators

14. Site Dashboard shows us information
specific to the site
• Open Actions Aging
• Overall Site Risk Trend
• Risk Indicator Trends
• Histograms to show items like AEs
• Site automatically marked across all
indicators

15. OPRA has Reports for Study, Site, and
Risk Overview- these reports can be
viewed in the system, downloaded as a
.pdf report, or exported into Excel

16. OPRA captures the audit trail for actions
performed in the application as well as
what, when, and who processed the
source data to create the graphs

17. OPRA allows the easy
creation of new KRIs or
modification of existing
KRIs from your library
Selecting which indicators you
want for any given study is as
simple as ticking a box

18. Once we know how well risk is
being detected, we can adjust
thresholds accordingly….

19. So, why choose ?
 Cloud based, per study model
 Cost-effective, rapid deployment
 Integrates with any data source
 Library of KRIs
 Include your own KRIs
 Unique, built-in statistical models
 Simple to use dashboard
 Dynamic visual interface
 Historic data analysis and trending
 Centralized record of all observations and actions
 Full service provider – consultation, training, support
TRI – Where’s The Risk?

20. To learn more about OPRA, TRI’s
accompanying RBM services and how you can
apply such expertise to your organization to
instantly improve study quality- we'd love to
talk further with you….
Kendal Quinn
Global Head, Business Development
kendal.quinn@tritrials.com
info@tritrials.com
919.747.9400 (Work)
919.879.4458 (Cell)
www.tritrials.com
TRI – Where’s The Risk?