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Delivering Exceptional ClinicalTrial

Performance

A CRO

InClin delivers exceptional clinical trial performance

On Time On Budget With personalized, high-quality service

For more than 96 sponsor companiesOn more than 247 trialsIn more than 40 CountriesIncluding 50 pivotal Phase 2 and Phase 3 studies With a 95% on-time or early performance record in Phase 2 – 3 studies

What InClin Does

Consulting andCRO Services

Major ClinicalPrograms Completed

InClin’s Performance

Phase 1 Phase 2 Phase 3

Antiviral: 1999 NDA – Flu

Anti-Infective: 2006 NDA – Oesophageal Candidiasis

Pain Management: 2008 NDA – Dental Anesthesia Reversal

Primary Immune Deficiency: 2011 BLA – SC

Cardiovascular: 2008NDA Bioequivalence

Anti-Infective: 2010 NDA – cSSSI + CABP

Primary Immune Deficiency: 2005 BLA – IV

Anti-Infective: 2007 NDA – cUTI + cIAI

Anti-Infective: 2008 EMA and Canadian Approval – Nosicomial Pneumonia (HAP and VAP)

Cardiovascular: 2010sNDA Bioequivalence

InClin’s Performance247 Trials

>40 Countries14,751 Patients Enrolled1,708 Sites Activated

6 NDAs1 sNDA

7 New Marketed Products2 BLAs

Over 14 Years

Core Expertise

PlanningConductingclinical trials

ManagingClinical Trials

Project Management Clinical Monitoring Data Management Biostatics Medical Writing Clinical Research

ConsultingCRO Services

Consulting

Services

Senior Quality Assurance

GxP Auditing

Clinical Program Planning

Protocol and Medical Writing

Regulatory AffairsHigh Performance Project Teams

Our Company

Who We Are A premier North

American Clinical Research Organization (CRO)

Provide Phase 1 – 4 clinical research services to the pharmaceutical, biotechnology & medical device industries

Phase 1 – 3

Experience

Proof-of-Concept With PK, biomarker

& imaging

requirements

Global Studies Pharmacoeconomic

Studies Class I-III: 510(K) Extension/Marketing trials

3Phase

First in man, SAD, MAD, with extensive PK and biomarker requirements, TX populations

Special Population, TET studies

Phase

2

1Phase

DiverseTherapeuti

cExperience

Cardiovascular Class III Devices CNS Dermatology Gastroenterology Hematology Immunology/Immune Deficiency Infectious Disease

Antibiotic/Antifungal/Antiviral Metabolic Bone Disease/

Endocrinology Oncology Ophthalmology Pain/Pain Management Pulmonary Diseases Seasonal Illnesses

MainTherapeuticAreas Anti-infective

50%

Anti-viral 10%Im-

munology8%

Cardio-vascu-lar8%

Oncology 24%

Experienceby Segment

Pharma,50%

Biotech; 30%

Medical Device;

20%

InClin has delivered exceptional global clinical trial performance in more than 40 countries

NorthAmerica

SouthAmerica

WEU

EEU

Asia

India

South Africa Australi

aNew Zealand

The Foundationof Success:People and

Methodologies

Project Success!

Our staff retention rate

is 95%

The team you start with is

the team you end with

Highly experienced and highly

trained

TheInClinTeam

Functional Group Staff

Average Years

Experience

Average Global Trial Experience

Senior Management Team

5 20+ 15+ years

Clinical Project Managers

16 10+ 7+ years

CRAs and Regional CRAs

75 7+ 3 + years

CTAs 5 3+ 5 + years

Regulatory Specialists 2 7+ 5 + years

The InClin Team

• Drug safety monitoring and reporting

• Medical monitoring• Data management and

biostatistics•These Partnerships are based on:• Synergy with our people and our

methodologies• Strong performance records• Qualified vendor status

•These Include:

Integrated Partnerships

For select functions, InClin partners with quality organizations that share our key values

Strong Quality Framework

Expert Project Management

Proven Processes

OurMethodologies

InClin Quality Framework

Regulated Activities

Non-Regulated Activities

Policies

Methodologies

Clinical Operations Procedures Plans, manuals, project tools

Training Materials

Function-Specific SOPS

Cross-Functional SOPS

SOPs provide standardized processes for all services

Proven tools and methodologies

On-going project oversight by the InClin executive

management team

We provide our experienced

project teams with a strong

organizational structure and

integrated framework Independent Quality Unit

oversight of each project

Quality isbuilt-in to our

methodologies

MethodologiesInClin Quality Framework

Our Quality Record

2 Pre-Approval Inspections

(PAIs)

30+ FDA Site Audits

7 New Products Approved

InClin-managed studies and sites have undergone

multiple regulatory audits

Each directly impacts quality.They are totally interrelated – if one is impacted it impacts the others.

Our project management methodology focuses on three key project variables

InClin’s success comes fromour ability to manage them all effectively.

Time

(Sch

edule)P

eople

& $

$ (B

udget

)

Customer Requirements (Scope)

Quality

Expert Project Management

Core Methodology

Integrated Clinical

Operations Approach

Strong Planning and Project

Management

Strong Teams

Effective Communication

High-Quality Monitoring and

Data Review

Strong Vendor Management Executive

Management

Oversight

Our Methodologies Focus on the Basics

InClin delivers exceptional clinical trial performance

On Time On Budget With personalized, high-quality service

For more than 96 sponsor companiesOn more than 247 trialsIncluding 50 pivotal Phase 2 and Phase 3 studies

With a 95% on-time or early performance record in Phase 2 – 3 studies

What InClin Does

© 2011 InClin, All Rights Reserved.