INC FactSheet 7-19-11

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Therapeutic Foresight. Trusted Results.™

FACT SHEET

INC Research Fact Sheet | July 2011

INC Research is a therapeutically focused global clinical research organization (CRO)providing a complete range of Phase I – Phase IV clinical development services for the

world’s biopharmaceutical companies. Our mission is to help our customers bring

products to market to improve world health.

INC Research provides signicant scale, scope and expertise to deliver innovative clinical development

approaches and strategic alliances that meet the needs of our customers. In July 2011, INC Research acquired

Kendle International, a leading global CRO, to create a new enviable force in global drug development

outsourcing.

With the addition of Kendle, INC Research is now better positioned to participate in evolving drug

development outsourcing models that require broader capabilities and critical mass. The new company

is also in a stronger position to drive overall quality and efciency improvements through more

innovative and forward-thinking outsourcing approaches. Customers that partner with the new

INC Research will benet from our:

•GlobalScaleandExperience. Our operations extend across six continents with experience spanning

more than 100 countries. We are able to deploy more high-quality teams worldwide to handle

large-scale clinical trials.

• ReinforcedTherapeuticExpertise. INC Research and Kendle have combined their extensive therapeutic

expertise to provide global therapeutic coverage in the largest areas of R&D investment, including

cardiovascular, CNS, endocrine, infectious disease, oncology and respiratory. These therapeutic

areas accounted for approximately two-thirds of the total U.S. drug development pipeline in 2010

(Frost & Sullivan).

•NewLevelsofOperationalExcellence. With expanded global size and scale, INC Research can

deliver the next generation of strategic partnerships. We have gained economies of scale to deliver

clinical development programs more cost effectively. We also are evolving our proven Trusted

Process® methodology to include more cutting-edge methods and tools to reduce variability and

increase predictability in trial outcomes across all phases of clinical development.

ACommitmenttoGrowthandExceptionalService

INC Research is committed to rapid growth in the global drug development outsourcing marketplace.

The Kendle acquisition marks the ninth successful acquisition and integration for INC Research in 10 years.



FACT SHEET

INC Research Fact Sheet | July 2011www.incresearch.com

Post-Approval: At INC Research, we understand that Post-Approval research is different from Pre-Approval

development. To help you achieve success with your Post-Approval research initiatives, we focus on efcient

and cost-effective delivery of studies and support programs designed to meet your needs for real-world data.

We are a full-service provider, offering customized post-approval solutions across every clinical study, from

study design consultations to the completion of the nal study report.

UniqueDataServicesandDataManagementTools

INC Research provides a full range of data services and expertise to accelerate your clinical trials

with greater accuracy and efciency. As part of our Trusted Process, our tools for data management,

electronic data capture (EDC) and biostatistics allow us to monitor data quality and study

performance in real time and on an ongoing basis.

Biostatistics

INC Research’s Biostatistics Group provides our customers with sound statistical guidance and input atevery phase of a product’s development. The group is expert in randomization methods, data collection,

instrument design and data cleaning. The team has considerable experience with paper and electronic

common technical document (CTD) submissions, the U.S. Food and Drug Administration (FDA) and the

European Medicines Agency (EMEA), having submitted more than 25 New Drug Applications (NDA) and 90

Marketing Authorization Applications (MAA).

StrategicandRegulatoryConsulting

The ability to determine the commercialization potential of a new drug is more important than ever. To help

our customers succeed, INC Research offers several strategic and regulatory consulting service offerings:

• INCResearch’sStrategicConsultingGroup provides expertise that balances a global perspective

with an understanding of important regional nuances to maximize the value of scientic knowledge,

intellectual property and the content of your portfolio.

•INC Research’s AVOS Consulting offers independent perspectives on the future business

environment for healthcare products and services. AVOS Consulting’s strategic, operational and

nancial analyses help life sciences companies compete successfully in an increasingly

economically challenging and competitive environment.

• INCResearch’sRegulatoryAffairsteam has extensive clinical trials expertise and offers experience

in strategic submissions planning. With ofces in the United States, European Union, Canada, China,

India, and Latin America, our Regulatory Affairs staff is well versed with rapidly changing regulatory

requirements across the globe. Our multifunctional global Regulatory Affairs team works closely with

our regional technical experts to help guide strategies for product development in Phase I-IV clinical

trials, product approval and post-approval studies.



FACT SHEET


StrategicAlliances

INC Research is at the forefront of creating new models in which sponsors and CROs act as true

partners with shared goals. We are uniquely positioned to build strategic alliance partnerships based

on our expertise across the complete range of Phase I-IV clinical trials, expertise in pipeline

management, registration strategies, compliance, due diligence and other aspects of drug

development and commercialization.

We work closely with customers to structure and manage successful alliances that share risks, increase

costs savings, improve resource commitments and drive benets in quality, consistency, efciency

and the bottom line. These benets go far beyond what is possible in a tactical outsourcing relationship

and are demonstrating the true value of strategic outsourcing.

FunctionalServicePartnerships

INC Research is among the pioneers of the FSP approach. This partnership model streamlines many of therepetitive tasks associated with the clinical trial process to increase time-saving and cost-saving synergies.

The end result of implementing a FSP approach is greater predictability and more consistent delivery of

services across all protocols. Today, INC Research’s FSP model touches more than 150 protocols every day.

InnovatingDrugDevelopmentastheNext-GenerationCRO

Faced with continued nancial and competitive pressures, biopharmaceutical companies are moving

beyond traditional outsourcing relationships and exploring new types of strategic partnerships

designed to deliver greater benets throughout the product development lifecycle.

INC Research is uniquely positioned to deliver in the next generation of strategic partnerships and

is driving change in the outsourcing industry with new approaches designed to improve the overall

quality and efciency of drug development. We are innovating new clinical research techniques,

rening best practices and implementing the latest technologies to help our customers succeed and

bring their products to market faster.

We often are among the rst to spot new trends in pharmaceutical research, develop new tools and

build expertise in areas of interest to our customers. For example, we have been at the forefront

of adaptive clinical trial design and building forward-thinking strategic alliances based on new risk-

sharing and incentive structures.

We believe these innovations — and the innovations we are currently developing and will develop

— help our customers effectively address the growing list of constituencies they work with, from

regulatory bodies and policymakers to payors and patients.



FACT SHEET


The Trusted Process®

Trust is the key for any long-lasting relationship and, since 2006, INC Research has conducted Phase

I-IV trials based on our proprietary Trusted Process, a proven, metrics-driven, process-oriented

methodology that ensures consistent delivery of the highest quality results to our customers.

The Trusted Process reduces risk and ensures reliability and predictability by standardizing the

operational aspects of a trial and maintaining quality controls at every phase of the clinical

The result is substantially reduced operational risk and variability and faster cycle times.

The Trusted Process is not static. INC Research is constantly evolving the process based on feedback

from our customers, the availability of new informatics tools, and the changing realities of the industry.

The Trusted Process turns customers into repeat customers because it delivers predictable,dependable outcomes. Ultimately, the Trusted Process helps our people help yours by focusing on

the delivery of high-quality clinical trial results.

Management Team

The executive leadership includes:

• David Gill,

• Jamie Macdonald,

• Neil MacAllister, Executive Vice President, Corporate and Business Development, INC Research

• Mark Roseman, DSc, Executive Vice President, Business Development and Marketing

and President, AVOS Consulting

Your Trusted Partner

The biopharmaceutical ecosystem is rapidly undergoing profound and systematic changes. With our

expanded scale and depth of therapeutic capabilities, improved global reach and economies of

scale, and focus on innovation and quality delivery through the Trusted Process, INC Research is

uniquely positioned to enter into strategic alliances with biopharmaceutical companies, small and

large. We look forward to becoming your Trusted Partner, helping you deliver the next generation

of life-saving medicines.

INC FactSheet 7-19-11

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