An Overview of TRI and OPRA

the risk-based monitoring company

Table of Contents

Slides 3-5: TRI- Who are we, what have we achieved, and how do we differentiate?

Slides 6-10: TRI’s RBM Service Offerings

Slides 11-29: OPRA- Explanation of OPRA, system capabilities, and overview of

functionality

TRI – Who are We?

First company entirely dedicated to RBM and quality oversight

Creators of the world’s first purpose-built RBM platform, OPRA

First Company to offer a true, holistic RBM solution

Technology

Study specific services

Implementation services

Hosting

TRI, or Triumph Research Intelligence, was founded in 2013 as a sister company to Triumph

Consultancy Services which has been exclusively dedicated to the clinical industry for the

last 14 years

TRI holds a number of ‘firsts’ in the industry….

What Have We Achieved?2002

2013

Formed TRI

• RBM research

• 20+ company meetings

• Industry bodies

• Reg authorities

Founded Triumph Consultancy

• Clinical systems implementation

• Clinical systems development

• Systems integration

• Data migration

• Reporting / BI

• Process improvement

• Training

• Change Management

50+ Projects

20+ CRO and Pharma Clients

5 of top 10 CROs

2014

2015

Raised Seed Funding

• Developed Proof of

concept

• Customer / prospect

roadshow

• Signed first pilot

customers

Started Pilot projects

• Pilots with 3 CROs

and a mid sized

pharma

• Large scale global

RBM

implementation for

top 5 Pharma

• Major upgrades to

pilot platform

2016

Second round funding

• Full production

readiness

• Full validation

• Further enhancements

Production ready

• First customers

signed

• First audit complete

• Next release

planned

How do we differentiate?

.

Track record

Fully validated,

field tested product

Leader, not follower

Understand process, and pharma/CRO

business

Very flexible product, source

agnostic

For purpose, not re-

purposed

A 3 stage process, driven from the study protocol:

• Protocol risk assessment

• Review of critical data and processes

• Visualization methods

• Application of appropriate statistical models

• Weighting, thresholds and indicator design documentation

• Indicator validation support

RBM Services

Risk Indicator Design

RBM Services

RBM Assessment and Planning

A rapid assessment of your progress and current capabilities is performed to determine the most effective way forward for your organization. Areas of assessment include the following:

• How will RBM be employed and how will it impact your current planning and monitoring processes?

•What roles will be impacted by RBM and how will they change?

•What data are you going to use to assess risk, and how will you access that data?

•What technologies are you going to implement to support the processes of planning, risk assessment, risk

management and on-going quality oversight?

•How are you going to train your staff in the new RBM processes and technologies?

•How are you going to manage the change with respect to sponsors, CRO

partners and sites?

•What is the business case for RBM in your company, and how are you going to

measure and monitor achievement of that business case?

RBM Services

RBM Technology Implementation

Choosing the best technology to suit your RBM strategy can be a challenge.

- Do I try to develop my own?

- Do I try to re-purpose something I already have?

- Do I implement purpose built RBM technology?

How do we evaluate RBM technology?

• Does your business intend to follow some or all of the TransCelerate methodology?

- If the answer to this is ‘yes’ then we have a pre-defined assessment tool based on the

TransCelerate functional requirements which will allow us to very quickly determine which

aspect of the methodology you want to follow and therefore what the core requirements of

your system should be.

- If the answer is ‘no’, then we take a more process driven approach, and start by understanding

the operational approach you intend to take to risk-based monitoring, the processes you will

want it to support and then ultimately to define the requirements for your RBM system.

RBM Services

RBM Training

Risk-Based Monitoring Training –everything you need for successful training and user adoption

• Training needs analysis and planning

• Development of training materials (classroom, web-ex or e-learning)

• Development of reference and support materials

• Classroom end user training

• Train the trainer

• Web-ex remote training delivery

RBM Services

RBM Change Management

The adoption of RBM for most organizations is a considerable change management challenge.

As experts in both change management and Risk-Based Monitoring, TRI is actively engaged in

supporting both Pharma and CRO’s in the adoption of risk-based monitoring

Our change management methodology…..

We have a well defined, field proven CM methodology. We use

the methodology to assess change readiness, to establish current

progress and ultimately to build a clear, pragmatic change plan

for your organization.

Our methodology covers both the “driving factors” of developing

and implementing your risk-based monitoring processes and

technology, as well as the “releasing factors” of breaking old

habits, changing approaches and role and ultimately moving

away from a traditional monitoring environment.

What is OPRA?

OPRA is the first and only purpose-built

operational platform of it’s kind on the

market for

Risk-Based Monitoring and Quality

Oversight

What is OPRA?

OPRA is a cloud-based, fully validated 21 CFR Part 11 compliant system

Requires nothing more than an internet browser for user access

Source system agnostic – there are no limits on the number or types of

source systems

Completely user configurable-

Holds a library of KRIs

Ability to easily add customized, study-specific key risk indicators

Holds a unique statistical model used to create the data visualizations

Very simple to use dashboard and dynamic visual interface

Holds historic data and trending analysis at a site level as well as for

individual indicators.

Holds record of all observations and actions taken throughout the study,

so all activity is tracked and has the ability to be managed in the system

Keeps an audit trail for all actions performed as well as for the data

processed within the system

Keeps an audit trail for all actions performed as well as for the data

processed within the system

OPRA

System Capabilities – What is OPRA?

Cloud based

Data visualization Statistical 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, risk assessment, change

management, indicator design, training, support

TRI - Where’s The Risk?

www.tritrials.com info@tritrials.comJoin the official LinkedIn RBM group, Risk-Based Monitoring in Clinical Trials, by copying/pasting

the link below into your web browser and requesting to join:

https://www.linkedin.com/groups/8180947