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Making Clinical Trials Better, Together An explanation of our company, our experience and our services

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Making Clinical Trials Better, Together

An explanation of our company,

our experience and our services

Triumph is a global business solutions

company focused entirely on

improving the quality and reducing

the cost of clinical trials.

We do this through the application of

optimized business processes,

supported by efficient and appropriate

clinical systems technology.

Background

Triumph was founded 13 years ago, initially focusing on clinical systems implementation. Since those beginnings, we’ve evolved into a highly experienced, highly capable,

life-science specific professional services firm.

We work in the clinical trials industry, and this industry only.

We are an entrepreneurial and creative team, and take great pride in challenging conventional thinking in order to deliver the best possible solutions to our customers.

Triumph is an international company, yet our size allows us to take a very personal and customer focused

approach in all of our engagements.

Our office locations:

Raleigh, NC and London, UK.

Why Triumph?

Our team is composed of top industry professionals who are uniquely positioned to develop and deliver solutions from the perspective of both the customer and industry best practice.

More reasons Triumph should be your first choice of business partner:

• We have a proven track record of success and hold long term relationships with customers as a core value

• We have amassed a broad spectrum of implementation accelerators and IP which allow us to be effective immediately, and deliver much more quickly

• The time it takes for us to accomplish the tasks we’re given is well above industry standards

• Our expertise in clinical trial systems and clinical trial process allow us to provide better solutions than large consulting firms who generalize across many systems and industries

• Our size, business model, effectiveness and efficiency allow us to pass cost savings to our clients, resulting in the most cost-effective solution

• We have experience with all sizes of CRO’s and Pharma's - from 50 employees to 10,000 employees

• Our partnerships with technology vendors give us a reach and insight our customers are not able to develop on their own

Ind

ustry E

xperie

nce

IP / A

ccele

rato

rs

Improved Capability

Operations

Technology

Both

Key Customers

How We Operate

Triumph operates at whichever level of the organization is appropriate for your needs, with specifically designed solutions and approaches for each level.

Strategic

Operational

Tactical

eClinical Strategy

Data and Information Delivery Strategy

Operating Model Definition

Business Process Definition and Mapping

Solutions to Regulatory Challenges

Metrics Definition and Implementation

Clinical Systems Selection, Implementation and Enhancement

Data Integration and Information Delivery

Training Development and Delivery

Strategic

• Ensuring alignment between core

business processes and clinical

technology

• Technology gap identification

• Identification and selection of appropriate

clinical technologies

• Industry insights into trends and best

practice

• Strategic planning to ensure higher value

from existing systems

• Prioritization support for existing and

planned projects

• Development of your data strategy – data

becoming a corporate asset

• Defining your information and decision

support needs

• Development of data mastering and

storage strategy

• Ensuring information is delivered in the

right format to support each business

function

• Development of data governance and

stewardship strategies to ensure

ownership and maintenance

• Definition of current and planned state

operating models

• Ensuring alignment between operating

model and corporate strategy

• Identification of focus areas for

automation and integration of processes

• Development of corporate objectives,

goals, strategies and measures

• Organizational communications and

change management to ensure effective

adoption of planned state model

eClinical Strategy Information Delivery Strategy Operating Model

triumphconsultancy.com/strategic_consultancy.html triumphconsultancy.com/foundation.htmltriumphconsultancy.com/information_delivery.html

Operational

• Definition and optimization of end to end

clinical trial process

• Mapping and supporting documentation

for communication of process

• Mapping of roles, systems and data to

business processes

• Mapping of metrics and performance

indicators to business processes

• Gap analysis of clinical systems capability

to support business process

• Definition of upcoming regulatory

changes and the impact those changes

may have on your business

• Operational solutions to RBM and IDMP

• Helping you determine the challenge and

opportunity those changes present to

your business and developing plans to

address

• Use of accelerators to ensure that your

project is delivered as efficiently and cost

effectively as possible based on our

previous experiences

• Development of your metrics based

strategy for performance, quality and

vendor management

• Definition of KPIs and KRIs

• Impact assessment on role definitions

• Development of leading indicators for

forecasting and better management

• Mapping of metrics to processes and

systems

• Guidance through adoption of industry

standards such as MCC

• Visualization of metrics for reporting and

decision making

Business Process Solutions to Regulatory Challenges Performance and Quality Metrics

triumphconsultancy.com/clinicalprocess.html triumphconsultancy.com/metrics.htmltriumphconsultancy.com/regulatory.html

Tactical

• Needs analysis and requirements for all

key clinical systems (SSU, eTMF, CTMS,

EDC, Safety, Finance) based on functional

and process needs

• Vendor selection, due diligence, RFI and

RFP development

• Systems implementation and deployment

• Systems design, development, testing

and validation

• Post implementation support and help

desk implementation

• Definition of information delivery

requirements

• Data mastering, quality and compliance

management

• Definition, development and

implementation of point to point

integration

• Definition, development and integration

of data warehouse and data mart

solutions

• Development of data visualizations and

standard reports

• Training needs analysis

• Training materials development

• User guide development

• Computer based training development

• Classroom and Web-ex training delivery

• Train the trainer delivery

• Selection, implementation and set up of

learning management systems (LMS)

• Development of staff training matrix /

learning paths

• Development of on line support systems

Clinical SystemsData Efficiency and

Information Delivery Training

triumphconsultancy.com/clinical_systems.html triumphconsultancy.com/training.htmltriumphconsultancy.com/data_efficiency.html

Oversight

• Provision of industry experienced project

and program managers in the areas of

systems and business change

• Definition of project work breakdown,

timelines, budgets and resource plans

• Management of project and program

cost, quality, deliverables and resources

• Risk and issue management

• Implementation of planning and resource

management systems

• Project and portfolio prioritization

• Senior management reporting and

program governance

• Implementation of structured change

management methodology

• Development of corporate, program or

project level change plans

• Internal and external communications and

marketing

• Change readiness assessment and

stakeholder analysis

• Management and measurement of

change impact

Project and Program Management Change Management

triumphconsultancy.com/project_management.html triumphconsultancy.com/change_management.html

More Information

Triumph is committed to continual improvement and growth within the industry.

We’d love to hear more about your business, goals and challenges.

Kendal Quinn

Head, Global Business Development

By website:

www.triumphconsultancy.com

By email:

[email protected]@triumphconsultancy.com

By phone:

919.747.9400 ext. 2225919.879.4458