OPRA, An In-depth View

Brought to you by:

TRI- Where’s the Risk?

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

Cloud based

Data visualizationStatistical analysis

Zero footprint

web client access

CFR compliantAudit trail

User configurable

Activity management

Trend analysis

The OPRA log-in screen

Logging-in takes us directly to the Study Dashboard

Each panel represents a key risk indicator

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

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.

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

more detail

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

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

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

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

Study profile has filtering capability to focus on individual indicators

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

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

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

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

Once we know how well risk is being detected, we can adjust

thresholds accordingly….

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?

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 QuinnGlobal Head, Business Development

[email protected] [email protected]

919.747.9400 (Work) 919.879.4458 (Cell)

www.tritrials.com

TRI – Where’s The Risk?