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Copyright 2013 Quintiles

Industry-Sponsored Trials Who is Getting the

Benefits?

Goh Tse SengClinical Operations

Quintiles Malaysia Sdn Bhd

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Worldwide, Next DoorThe worlds largest CRO

Quintiles Offices

Quintiles Central and Affiliated Labs

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3

A Comprehensive Range of Services

> Clinical monitoring

> Data management

> Pharmacovigilance

> Biostatistics

> Medical writing

> Interventional IIIb/IV

> Observational

studies / safety

surveillance

> Patient Registries

> Real-world research

> Consulting

> Capital investment

> Scientific advisory

boards

> CRA training

> Regulatory

submissions

> Regulatory

consulting

> IND preparation

Clinical Development> Planning and Design> Phase I-IV

FSP OutsourcedServices

Real-world &Late PhaseDevelopment

AdvisoryServices Regulatory Services

Benefits of Integrated Services> Lower overall study costs

> Better site support

> Reduced timelines

> Simplified trial management

> Central Labs> Cardiac Safety

> Integrated Site & Patient Services

> Deep Therapeutic Expertise

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Global Therapeutic Experience

4

This chart representsstudies conducted from2000-2010.

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Quintiles Malaysia Clinical experience

0200

400

600

800

1000

1200

1400

1600

0

5

10

15

20

25

30

Quintiles Malaysia ClinicalExperience

# of Studies Total Patients Randomized

Therapeutic Area # of StudiesTotal Patients

Randomized

Total

Initiated

Sites

CARDIOVASCULAR 14 495 54

ENDOCRINOLOGY 15 909 104

GASTROINTESTINAL 6 66 25

HEMOG/ONC/TRANSPL

ANTATION 11 94 36

INFECTIOUS DISEASE 24 1414 56

NEUROLOGY 8 143 24

OPHTHALMOLOGY 1 6 2

PSYCHIATRY 16 291 63

RESPIRATORY 8 445 36

RHEUMATOLOGY 14 253 59

WOMENS

HEALTH/SEXUAL

HEALTH 2 11 6

NO DATA AVAILABLE 2 2 3

TOTAL 121 4129 468

#

ofstudies

#ofpatients

Source: Quintiles Investigator Performance Database 2.4 report on 27May 2013. Contains studies conducted from 1998 to present.

Total of122 studies with 4129

patients and 66 unique sites

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Who is Getting the Benefits?

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Investigator

Institution

Country

Patients

General

Population

Sponsor

Who are Getting the Benefits?

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Investigators View:

Why Conduct Industry-Sponsored Trials?

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Investigators View:

Why Conduct Industry-Sponsored Trials?

Source: Clinical Trial Magnifier Vol. 3:6 Dec 2010

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Benefits to Investigator

InvestigatorAdvancementof scientificknowledge

Education

Training

PracticalExperience

A changefrom routine

work

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Benefits to Investigator

Investigator

Sense ofaltruistic

Scientificleadership /Professional

standing

Administrativeassistance

Financial gain

(support

in-house IIT)

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Benefits to Institution

An established clinical research infrastructure /facilities

Skillful investigators and site staff

Institutional track records and reputation

Revenue

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Benefits to Country

Globalrecognition

of itsresearchers

expertise

Accelerated /Improved

policies byregulatoryauthority

IncomeJob

opportunities

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Benefits to Patients

Early access to new treatment

Renewed hope

Better patient care

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Benefits to Patients

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THANK YOU!