Asia Pacific Overview - ICON plc

For Internal
use Only
Asia Pacific
Overview
Reference Guide

ICON has a strong presence in Asia Pacific with 800 staff located in 14 countries. The team
has wide therapeutic expertise including Oncology, Cardiovascular, Central Nervous System
and Metabolic disorders and clinical research experience that extends from small local and
pan Asia Pacific programs, to large global clinical trials.
Contents
ICON Central Laboratories supports the
Asia Pacific region from wholly-owned
facilities, strategically located in Singapore
and India. Both laboratories are CAP
accredited and NGSP Level I certified, utilise
the same testing platforms and operate to
the same high quality standards as all ICON
Central Laboratory locations.
This guide is designed to inform you of
the detail behind ICON’s capability in the
region and to help support your clients
by choosing the right locations for their
development programs.
SINGAPORE
Singapore
JAPAN
Tokyo
Osaka
KOREA
Seoul
INDIA
Chennai
Bangalore
New Delhi
CHINA
Hong Kong
Beijing
AUSTRALIA
Sydney
NEW ZEALAND
Aukland
THAILAND
Bangkok
TAIWAN
Taipei
Japan 04
China 05
Hong Kong 06
Taiwan 07
Korea 08
Indonesia 09
Malaysia 10
Philippines 11
Singapore 12
Thailand 13
Vietnam 14
New Zealand 15
Australia 16 -17
India 18 -19
Note: Home based staff in Malaysia, Indonesia, Philippines and Vietnam.

Japan
China
For Internal use Only
4
Fast Facts
• Capital: Tokyo
• GDP/Economy: 2nd largest economy in the world,
nominal GDP US$4.9 trillion, 2008
• Health Expenditure: 9.11 % of GDP, 2007
• Population: 127.7 million, 2009
• Average Life Span: 82 years, 2009
• Languages: Variety of Japanese dialects
• Adult Literacy Rate: 99%, 2009
Health Trends
• Healthcare services provided by national and
local governments.
• Payment for personal medical services offered
through a universal health care insurance system
that provides relative equality of access & fees set
by government committee.
• People without employers insurance can participate
in a national health insurance program administered
by local governments.
• 1973, all elderly persons covered by governmentsponsored
insurance.
• High density population downtown benefits clinical
research as a large group of patients are available to
health care professionals.
• Smaller local communities within hospital regions
develop strong patient/research links.
• Pools of recurrent patients within specific
therapeutic areas for studies.
• Compliant patients due to familiarity with
research staff.
• Large group of ageing people.
• 2nd largest health care market.
• Common medical conditions: Oncology, Diabetes,
Gastroenteritis, Elderly, Hematology, Respiratory
Disease, Cardiovascular, Hepatitis, Infections,
CNS, Musculoskeletal & Joint disorders,
Immunology, Vaccines.
Clinical Trial Landscape
• 30 day regulatory review and approval for Clinical
Trial Notification to PMDA.
• Accepted the on-site IRB and the centralised IRB
for the site.
• National and University hospitals provide dedicated
research teams across a variety of therapy areas.
• Clinical Trial network e.g. National Hospital
Organization network, spreads across large and
medium cities.
• Direct access to health care professionals.
• Japanese Investigators high attendees at
international conferences and are ICH/GCP and
Japan/GCP compliant.
• Good primary care network.
• Sites deliver predicted patient numbers.
• Patients are not easily recruited; SMO is popular in
Japan but is expensive.
• Higher costs & longer trials than the West.
ICON in the Country
• Presence in Japan since 1995.
• Rapid growth.
• Patient enrollment on two studies occurred 7
months earlier than planned.
• Experience in Global Epidemiological studies.
Services Offered
• Project Management & Clinical Operations
(Phase II - III).
• Medical Safety and Monitoring.
• Data Management.
• Regulatory Affairs.
• Medical Writing.
• Regulatory/Strategic Consultation.
• Phase l.
• Late Phase Research (Ph IV, PMS).
• Central Laboratories Service.
• Imaging Service.
• Biostatistics.
• Quality Assurance.
• Training.
• Contract Staff.
Staff Background
• 80 staff in Tokyo Office, 9 in Osaka Office
(Oct 2009).
• Highly motivated, enthusiastic and experienced
team led by Director of Operations, Japan.
Fast Facts
• Capital: Beijing, Largest city: Shanghai
• Economy/GDP: Third largest world economy after
the US & Japan, nominal GDP - US$4.4 trillion, 2008
• Health Expenditure: 5.5% of GDP, 2008
• Population: 1.3 billion, 2005
• Average Life span: 73 years, 2008
• Languages: China has 56 ethnic groups, the Hui and
Manchu use the same languages as Han people,
other groups have own spoken and written languages
• Adult Literacy Rate: 93% 2009
Health Trends
• Public health system overseen by ministry of health.
• 3.216 million beds in general hospitals and
health centres.
• New Rural Co-operative Medical Care System
(NRCMCS): 2002 initiative to overhaul healthcare
system and to make it more affordable for the
rural poor.
• Leading causes of death: increased incidence of
cancer, cerebrovascular disease, and heart disease.
• 3.489 million infected by Class-A or B infectious
diseases, with 10,623 reported deaths (2006).
Prevention & control of major infectious diseases
such as AIDS, tuberculosis, snail fever and hepatitis
B have been listed in the outlines of the country’s
11th Five-Year Plan for Social and Economic
Development (2006-10).
• 93 % of general hospitals above the county level and
70 percent of township health centres can report
outbreaks of infectious diseases and public health
incidents directly to health authorities via the Internet.
• Enhanced efforts to prevent and treat chronic
diseases such as high blood pressure, cardioand
cerebral-vascular diseases, diabetes and
malignant tumors.
Clinical Trial Landscape
• GCP completed in 1999.
• Attractive in clinical research field due to improved
clinical trial infrastructure and large pool of patients.
• For NCE, the approval timeline has been shortened
from approx 12 months to 7 months.
• New biologics approval timeline - approx 12 months
after regulatory submission.
• Clinical trial sites must be accredited by China SFDA,
there are 335 sites accredited in China.
• Global Trial Start-Up Timeline = Regulatory Approval
time plus IRB Time.
• Dossier preparation - 1 month, submission -
0.5 days.
• Technical review by the CDE of SDFA -
approx 7 months.
• Administration examination approval by SFDA -
approx 1 month.
• Overall timeline for approval after submission to
SDFA - 6 to 8 months.
• Start up Timeline for Global Trial in China -
approx 9 months.
• Successful US FDA site inspections with no critical
findings on quality, this strengthens pharmas’
confidence in China for global trials.
ICON in the Country
• Presence in China since 2005.
• ICON China has established good relationships with
the State Food and Drug Administration (SFDA) &
key opinion leaders in therapeutic areas.
• 9 years’ experience in drug regulatory affairs.
• 9 global trial applications conducted for big
pharmas’ obtaining regulatory SFDA approval in
approx 7 months on average.
Services Offered
• Project Management.
• Clinical Monitoring.
• Quality Assurance.
• Training.
• Medical Safety and Monitoring.
• Regulatory submission and consulting.
Staff Background
• 18 staff managed by a senior director, director &
associate director.
• Project Managers have over 8 years’ experience
in clinical research & CRAs have approx 3 years’
experience.
• Expertise in most therapeutic areas.
• Regulatory affairs experience for global trial
submission and approval cover:
• Oncology
• CNS
• Haematology
• Endocrinology.
For Internal use Only
5
MD Kanda Bldg. 6F&7F,
9-1, Kanda-Mitoshirocho,
Chiyoda-ku,
Tokyo, 101-0053, Japan
Contact:
Mary E. Bareilles
+81 3 733 4377
Mary.Bareilles@iconplc.com
ICON Clinical Research Pte. Ltd
Suite 1109-1111, West Wing, North building
Junefield Plaza, No.6 Xuanwumenwai Ave
Beijing, P.R. China, PC 100052
Contacts:
Yao Zhong
+86 10 8319 5119
Zhong.Yao@iconplc.com
Colin Stanley
+61 2 9859 3904
Colin.Stanley@iconplc.com

Hong Kong
Taiwan
For Internal use Only
Fast Facts
• Capital: Hong Kong (HK), a Special Administrative
Region of the People’s Republic of China
• GDP / Economy: World’s 12th largest trading
economy characterised by free trade, low taxation and
minimum government intervention. Mainland China is
its most significant trading partner. Nominal GDP US$
223.7 billion, 2008
• Health Expenditure: 4.8%, 2007
• Population: 7 million, 2009
• Average Life Span: 83 years
• Languages: Chinese, English
• Adult Literacy Rate: 95%, 2009
Health Trends
• Excellent public healthcare system consisting of
42 hospitals, 47 specialist clinics and 13 general
outpatient clinics, which contributes to a low
infant mortality rate of 3/1000 and an average life
expectancy of 83 years.
• Public hospitals / institutions managed by the
Hospital Authority.
• Hospital Authority managed over 27,600 hospital
beds which represented around 4 public hospital
beds per 1,000 population 06/07.
• Effective implementation of childhood immunisation
program versus vaccine-preventable disease has
contributed significantly on the reduction of the
incidence of certain diseases.
• Leading causes of death are; cancer, heart diseases,
cerebrovascular diseases, pneumonia, diabetes
mellitus, injuries, chronic lower bronchitis, Chronic
liver disease, suicide and chronic kidney diseases.
Clinical Trial Landscape
• ICH GCP adoption.
• Semi-sequential process: DOH approval granted
only after IRB approval (parallel submission to DOH
and IRB is allowed).
• Dossiers can be submitted in English: other than ICF,
all documents in English.
• Drug sample is required for DOH clinical trial
application.
• Clinical trials can be set-up in about 12-16 weeks.
• Most investigators are ICH-GCP trained.
• Centralised electronic patient records accessible via
an intranet system linking all hospitals and clinics
under the Hospital Authority.
• Accredited central laboratory facilities capable of
supporting multinational clinical trials.
• Prime logistical hub less than five hours’ flight
from most Asian countries and links to some
130 destinations worldwide by over 3,600 flights
per week.
ICON in the Country
• Presence in Hong Kong since 2003.
• Broad experience in various therapeutic areas.
• Excellent relationships with key opinion leaders in
various therapeutic areas.
• Hong Kong CRAs can support monitoring work for
ICON China when required.
Services Offered
• Major services: clinical operations and regulatory
consultancy.
• Project Management.
• Clinical Monitoring.
• Regulatory application.
Staff Background
• 1 project manager: 13 years in the clinical industry
and extensive experience in regulatory, project
management, clinical operations and monitoring in
Asia Pacific.
• 5 CRAs with over 2 years’ monitoring experience.
• High staff retention.
Fast Facts
• Capital: Taiwan
• Economy / GDP: Dynamic capitalist, export-driven
economy with gradually decreasing state involvement
in investment and foreign trade Nominal GDP exceeds
US$ 400 million
• Health Expenditure: 6.3% of GDP, 2007
• Population: 23 million, 2009
• Average Life Span: 78, 2008
• Languages: Taiwanese, Chinese and basic English
• Adult Literacy Rate: 95% 2009
Health Trends
• 85% of hospitals and 97% of clinics are private.
• National Health Insurance Program was launched
March 1, 1995. It is universal, mandatory, and
comprehensive. The BNHI collects premiums from
the insured and reimburses medical payments to
health care providers.
• Vision of the BNHI:
1. Proactively protect the health of the people.
2. Universal coverage to avoid the adverse selection.
3. To upgrade medical care quality.
4. Extend more care to the disadvantaged groups.
5. Maintain the financial stability.
• Leading causes of death; cancer, heart diseases,
cerebrovascular diseases, pneumonia, diabetes
mellitus, injuries, chronic lower bronchitis, chronic
liver disease, suicide and chronic kidney diseases.
Clinical Trial Landscape
• GCP announced in 1996 and fully implemented
in 1997.
• Parallel submission to IRB and HA after year 2001.
• Clinical trials can be set-up in 9-12 weeks.
• Second highest country in Asia Pacific to be involved
in FDA studies.
• Most investigators are ICH-GCP trained.
• Most institutions have clinical trial centres which can
assist in the set-up, conduct and coordination of
clinical trials.
• Strong Government support to conduct early
global trials.
ICON in the Country
• Presence in Taiwan office since 2006.
• 18 employees, 2009.
• Major services: clinical operations and regulatory
consultancy.
• Broad experience in therapeutic areas.
• Excellent relationships with key opinion leaders in
various therapeutic areas, and the evolving CDE
and regulatory authorities.
Services Offered
• Project Management.
• Clinical Monitoring.
• Regulatory support.
Staff Background
• Director of Clinical Operations has 14 years in
clinical industry and a wealth of experience on
regulatory and clinical operations in Asia Pacific.
• 2 project managers with 7 years’ clinical trial
experience and over 2 years’ project management
experience.
• CRAs have an average of 4.5 years’ clinical
trial experience.
• Staff turnover approx 5%.
For Internal use Only
6
7
ICON Clinical Research Suite 503,
5/F, Chinachem Exchange Square,
1 Hoi Wan Street,
Quarry Bay Hong Kong
Contact:
Ms Jessica Lin
+886 2 7706 6331 / +886 922 887 238
Jessica.Lin@iconplc.com
ICON Clinical Research Pte Ltd
13F, No. 287, Sec3
Nanjing East Road
Taipei, 10595, Taiwan R.O.C
Contact:
Ms Jessica Lin
+886 2 7706 6331 / +886 922 887 238
Jessica.Lin@iconplc.com

Korea
Indonesia
For Internal use Only
Fast Facts
• Capital: Seoul - second largest population (20.6
million) of any metropolitan area, after Tokyo which is
ahead of Mexico City, New York city and Mumbai
• Economy/GDP: South Korea, nominal GDP,
US$947 billion, 2008
• Health Expenditure: South Korea: 6.8% of GDP,
2007
• Population: 48 million, 2008
• Average Life span: South Korea 78 years, 2009
• Languages: Korean, English
• Adult Literacy Rate: 95%, 2009
Health Trends
• Pharmaceutical market worth 17 billion.
• 3rd largest pharmaceutical market after Japan and
China in the region and continues to grow in two
digits since 2002.
• Increased incidence rate for chronic and elderly
disease such as: CV disease, metabolic disease
and cancer etc.
• 96% of Koreans registered in National Insurance
Program. This drives patients to look for medical
treatment and good patient pools for clinical trials.
• Patient pools centralised in big university hospitals
mainly located in Seoul thus, excellent representation
of patients in university hospital regardless of disease
incidence rate and good patient number from one
investigator sites.
Clinical Trial Landscape
• Adapted ICH-GCP in 2000 and implementing KGCP
since 2001.
• Government invested USD$ 60 million to establish
15 regional clinical trial centres to support the clinical
trial activities in the region to encourage more
sponsored clinical trials and to strengthen Korea’s
position as an Asian biotech hub.
• Most hospitals have clinical trial centres, one stop
clinical trial support and dedicated supports for
clinical trial including study coordinator, continuous
training for investigators, dedicated pharmacy and
pharmacist, archiving facilities, dedicated monitoring
rooms etc.
• Korea is one of the fastest countries to start the
study among other Asian countries. Regulatory
approval process (if no comment) takes 4 weeks.
IRB meeting held bi-weekly in most of investigator
centres and English version of sponsor’s contract
template is acceptable.
• Regulatory requirements and review process is
well defined.
ICON in the Country
• Presence in Korea since 2005.
• Leading office for clinical trials in ICON Asia.
• Mainly clinical operation service.
• Managing 39 protocols including the following
therapeutic areas: Oncology: NSCLC, Breast,
Hepatocellular, Colorectal, Gastric, Prostate,
Cervical, Multiple Myeloma, Chronic Leukemia,
Astrocytoma, Endocrinology: DM, Growth Hormone
Deficiency, Infection: Hep B, Hep C, Pneumonia,
skin infection, Internal Medicine: Ulcerative Colitis,
SUI, Pulmonary: COPD, Neuroscience: Alzheimer
Disease, Major Depressive disorder, ADHD.
• 1 KFDA inspection for site and 1 KFDA inspection
for ICON clinical operation in Korea: no issue from
two inspections proves good quality service.
• ISO certified office in 2009.
Services Offered
• Project Management.
• ISIS.
• Clinical Monitoring.
• Quality Assurance.
• Training.
Staff Background
• 54 staff working in Korea as of Oct 2009 including a
Director and Associate Director, 5 Project Managers,
1 ISIS manager, 1 CORD Manager, 7 Senior CRAs,
26 CRA, 8 CTA, 1 Sr ISIS,1 HR, 2 Admin.
Fast Facts
• Capital: Jakarta
• Economy / GDP: 15th largest in the world, nominal
GDP US$511billion, 2008
• Health Expenditure: 3.7% of GDP, 2008
• Population: 237 million, 2008
• Average Life Span: 71 years, 2008
• Languages: Bahasa Indonesian
• Adult Literacy Rate: 92%, 2009
Health Trends
• Access to health care is not developed, hence
the availability of treatment naïve patients or
undiagnosed cases.
• Tertiary and teaching hospitals are predominantly
used for clinical trials.
• Leading causes of death: ischemia, hypertension,
cerebrovascular diseases, LRTI, COPD, DM, TB,
road traffic accidents and diarrheal diseases.
Clinical Trial Landscape
• Large patient population base.
• Submission to Local EC and HA completed
sequentially.
• For global trials requiring the shipping of biological
samples to a central laboratory outside of
Indonesia, the Materials Transfer Agreements
needs to undergo Mohr (Litbangkes - Health
Research and Development of Ministry of Health)
review and approval.
• Not all physicians are well trained on ICH-GCP,
hence selection of interested and experienced
investigators are key to success of clinical trials.
• Indonesian investigators require more CRA support
compared to other countries. Culturally, face-to-face
meetings are usually preferred by Investigators
with CRAs.
ICON in the Country
• Presence in Indonesia since 2007.
Services Offered
• Clinical trial application to ethics committees and
health authority.
• Study set up activities.
• Clinical Monitoring.
Staff Background
• CRA, 6 years’ experience in clinical monitoring,
almost 3 years with ICON.
• CRA, 4 years’ experience in clinical research &
2 years’ monitoring experience, joined Dec 2008.
• 3 home-based CRAs are medical doctors
with an average of 3.5 years’ clinical
monitoring experience.
Access to
health care is
not developed,
hence the
availability of
treatment naïve
patients or
undiagnosed
cases.
For Internal use Only
8
9
4th Floor, Ildong Pharmarceutical Building,
60 YangJae 1-dong
Seocho-gu
Seoul, 137-733, Korea
Contact:
Ms Jong Ran Kim
+82 70 7011 2832 / +82 10 9042 7880
JongRan.Kim@iconplc.com
Coordination through
Singapore Office
Contact:
Dr Grace Pei
+65 6895 8253 / +65 9295 1663
Grace.Pei@iconplc.com
Ms Juliet Mallabo-Palma
+65 6895 8203 / +65 9820 5864
Juliet.Mallabo-Palma@iconplc.com

Malaysia
Philippines
Fast Facts
ICON in the Country
Fast Facts
Clinical Trial Landscape
For Internal use Only
• Capital: Kuala Lumpur
• GDP / Economy: Economy is 29th largest in the
world, nominal GDP US$222 billion, 2008
• Health Expenditure: 4.3% of GDP, 2007
• Population: 28 million, 2009
• Average Life span: 73 Years
• Languages: Malay, Chinese, English
• Adult Literacy Rate: 95.1%, 2009
Health Trends
• Leading cause of death: septicemia, diseases of
the heart and pulmonary circulation, malignant
neoplasms, cerebrovascular diseases, pneumonia,
diseases of the digestive system, accidents, and
nephritic syndrome and nephrosis.
• Mental health is an increasing problem.
Clinical Trial Landscape
• Most investigators trained in UK, Australia, Ireland
and US.
• ICH-GCP well recognized and practice has
increased since implementation in 2000.
• MoH has a network of 17 Clinical Research Centres
(CRCs) nationwide to promote and support the
conduct of clinical trials in MoH hospitals.
• Clinical trial application to IRB and Drugs Control
Authority (Health Authority) can be done in parallel.
• Major University hospitals in the different states offer
clinical services for most therapeutic areas and have
an IRB to review clinical trial proposals.
• Hospitals under the MoH administration go through
a centralised review under the Medical Research
Ethics Committee (MREC).
• Currently there are 279 clinical trials conducted in
Malaysia and registered in clinicaltrials.gov
• Presence in Malaysia since 2000 with initial studies
being monitored by Singapore CRAs.
• 3 home based staff in Kuala Lumpur including a
Project Manager and 2 CRAs.
Services Offered
• Project Management.
• Clinical trial applications to ethics committees and
health authority.
• Clinical Monitoring.
• Study set up activities.
Staff Background
• Project Manager: 9 years’ experience in clinical
research, including 3 years’ project management in
Asia Pacific & 6 years’ clinical monitoring experience.
• CRAs have an average of 2 years clinical
monitoring experience in various therapeutic
indications.
• Capital: Manila
• Economy/GDP: Newly industrialised, economy
anchored on agriculture & substantial contributions
from manufacturing & mining, nominal GDP of
168.5 billion, 2009
• Health Expenditure: 3.8% of GDP, 2006
• Population: 92 million, 2009
• Average Life span: 71 Years, 2009
• Languages: Filipino and English
• Adult Literacy Rate: 92.6%, 2009
Health Trends
• Health care resource largely spent on hospital-based
curative services.
• Steep increase in non-communicable diseases.
• Communicable diseases morbidity remains high
despite control measures.
• Cardio Vascular diseases: 22% of Filipinos are
hypertensive.
• Leading causes of death: HTN & cardiac diseases,
cancer & malignant neoplasms, diabetes mellitus &
kidney disease.
• COPD - prevalence of tobacco use among adults
continue to rise.
• 22 million Filipinos live in filiriasis-endemic areas.
• Established centres for vaccine and malaria research.
Established
centres for
vaccine and
malaria research.
• Established government & private teaching and
hospital institutions for clinical trial conduct.
• Physicians & investigators are EU or US-trained.
• GCP implemented in 1993.
• Parallel submission to HA and EC.
• 237 phase II to IV studies
registered@clinicaltrials.gov site.
ICON in the Country
• Presence in Philippines since 2005.
• 4 Home-based staff.
• Indication Experience includes Type 2 DM,
hepatitis B, cervical dystonia, thrombo-embolism
in surgery and oncology (HCC, breast and CLL).
• T2DM site inspected in Jan 2009 with no
critical findings.
Services Offered
• Clinical Monitoring.
• Clinical trial applications to ethics committees and
health authority.
• Site set-up activities.
Staff Background
• 1 regulatory expert with 4 years in regulatory
submissions.
• 4 CRAs with an average of 3 years’ experience
in clinical research & monitoring experience in
T2DM, Hepatitis B, Oncology, TB, HIV & Rotavirus
vaccine trials.
For Internal use Only
10
11
Coordination through
Singapore Office
Contact:
Dr Grace Pei
+65 6895 8253 / +65 9295 1663
Grace.Pei@iconplc.com
Ms Juliet Mallabo-Palma
+65 6895 8203 / +65 9820 5864
Juliet.Mallabo-Palma@iconplc.com
Coordination through
Singapore Office
Contact:
Dr Grace Pei
+65 6895 8253 / +65 9295 1663
Grace.Pei@iconplc.com
Ms Juliet Mallabo-Palma
+65 6895 8203 / +65 9820 5864
Juliet.Mallabo-Palma@iconplc.com

Singapore
Thailand
Fast Facts
ICON in the Country
Fast Facts
ICON in the Country
• Capital: Singapore
• GDP / Economy: National economy is 44th largest in
the world, nominal GDP US$ $1.8 billion 2008
• Health Expenditure: 3.6% of GDP, 2008
• Population: 4.7 million, 2009
• Average Life Span: 82 years, 2009
• Languages: Malay, Chinese, English
• Adult Literacy Rate: 95.4%, 2009
• Presence in Singapore since 1999. 10th year
celebrated this year.
• Central Laboratories established in June 2007
& 8,000 square foot facility opened in 2009.
• The Singapore office manages the operations in
South East Asia: Singapore, Malaysia, Philippines,
Thailand, Indonesia and Vietnam.
• Project management and clinical monitoring
experience in most therapeutic areas and indications.
• Capital: Bangkok
• Economy/GDP: 20th largest country,
newly industrialised country, nominal GDP
US$273 billion, 2008
• Health Expenditure: 3.5% of GDP, 2007
• Population: 67.7m, 2009
• Average Life Span: 73 years, 2009
• Language: Thai
• Adult Literacy Rate: 93%, 2009
• Presence in Thailand since 2001.
• Thai office opened in 2005 with 3 CRAs, this has
now expanded to 6 experienced staff.
Services Offered
• Clinical trial application to ethics committees.
• Clinical trial dossier application to Thai FDA.
• Clinical Monitoring.
For Internal use Only
12
Health Trends
• Public health managed through a dual-health system
based on 2 hospital clusters, Singhealth and the
National Healthcare Group (NHG).
• Shift of leading cause of death to non-communicable
diseases.
• Effective implementation of childhood immunisation
program versus vaccine-preventable disease has
contributed significantly to the reduction of the
incidence of these diseases.
• Leading causes of death are; cancer, heart diseases,
pneumonia, cerebrovascular diseases, injuries,
diabetes mellitus and urinary tract infections.
• Increase in prostate and colorectal cancers for males
and breast and colorectal cancer for females.
Clinical Trial Landscape
• GCP implemented in 1998.
• Parallel submission to IRB and HA.
• Clinical trials timeframe approx 9-12 weeks.
Singapore often achieves first site initiated or first
patient included due to shorter start up timeframes.
• Most investigators are ICH-GCP trained.
• Majority of institutions have clinical trial centres which
can assist in the set-up, conduct and coordination of
clinical trials.
1 International Business Park,
#03-01A
The Synergy Tower Block
Singapore 609917
Services Offered
• Project Management.
• Clinical Monitoring.
• Pharmacy Services.
• Quality Assurance.
• Training.
• Medical Safety and Monitoring.
• Central Laboratory Services:
- Extensive test menu of safety, esoteric and
custom-developed assays.
- Flow cytometry, molecular diagnostics &
biomarker development.
- Sample tracking & storage.
- Fully CAP accredited.
- Comprehensive logistics support.
- Medically knowledgeable, on demand language
interpretation service to assist sites.
Staff Background
• Clinical Operations Team composed of 44 staff
managed by a Director and an Associate Director
based in Singapore.
• Directors have 14 - 17 years in the clinical industry
with extensive experience in regulatory, monitoring,
project management and clinical operation
management in Asia Pacific.
• Project Managers experience range from 2 to 4
years. Monitoring experience of CRA/SCRAs range
from 1 to 4 years in various therapeutic indications.
• Central Laboratories:
- Team composed of 12 staff.
- Director has more than 10 years’ experience in the
pharma industry with extensive experience in clinical
research in Asia Pacific.
- Staff turnover in the past 2 years is low.
Health Trends
• Shift of main causes of death from communicable to
lifestyle-related diseases.
• Upward trend in breast cancer and diabetes.
• Leading causes of death: HIV, ischemic and
cerebrovascular diseases, diabetes mellitus,
COPD, liver and lung cancer.
• Causes of illness: respiratory, musculoskeletal &
GI diseases cardiovascular disease, endocrine
(Diabetes Mellitus), allergies and neuropsychiatric
diseases on the rise.
Clinical Trial Landscape
• Good Clinical Practice implemented in 2000.
• Established institutions and expertise for the conduct
of multinational clinical trials.
• US or Europe trained investigators.
• Sequential process for IEC and Thai FDA approval
(import license).
• Therapeutic indications of strength locally include:
diabetes, infectious diseases (pneumonia,
HIV, malaria, Hepatitis B, vaccines), CV and
neuropsychiatric diseases.
• To date 502 clinical trials have been registered in
clinicaltrials.gov.
Staff Background
• No staff turnover within the last 2 years. 3/6 staff
have been with ICON for more than 4 years.
• All P/S/CRAs have an average of 4 years’
experience in clinical monitoring in various
therapeutic indications.
Established
institutions and
expertise for
the conduct of
multinational
clinical trials.
For Internal use Only
13
Contact:
Dr Grace Pei
+65 6895 8253 / +65 9295 1663
Grace.Pei@iconplc.com
Ms Juliet Mallabo-Palma
+65 6895 8203 / +65 9820 5864
Juliet.Mallabo-Palma@iconplc.com
Nee Ping Tan
ICON Central Laboratories
+65 6895 8271
NeePing.Tan@iconplc.com
Q House Lumpini
1 South Sathorn Rd.
Level 27, Tungmahamek, Sathorn
Bangkok, Thailand, 10120
Contact:
Dr Grace Pei
+65 6895 8253 / +65 9295 1663
Grace.Pei@iconplc.com
Ms Juliet Mallabo-Palma
+65 6895 8203 / +65 9820 5864
Juliet.Mallabo-Palma@iconplc.com

Vietnam
New Zealand
For Internal use Only
Fast Facts
• Capital: Hanoi, Largest City: Ho Chi Minh
• Economy/ GDP: National economy is 36th largest
in the world, in the past decade, economic growth
had been among the highest in the world. Nominal
GDP US$89.8 billion, 2008
• Health Expenditure: 6.6% of GDP, 2008
• Population: 86 Million, 2009
• Average Lifespan: 71 Years, 2008
• Languages: Vietnamese, English
• Adult Literacy Rate: 92.7%, 2009
Health Trends
• Hospitals are regulated by the Ministry of Health
(MoH) however some hospitals are regulated
directly by the respective provincial health service
departments.
• Major hospitals located in Hanoi & Ho Chi Minh.
• Underdeveloped health system offering opportunities
for clinical trials requiring treatment naïve subjects.
• Leading causes of death are ischemic heart,
cerebrovascular and pulmonary diseases,
tuberculosis, perinatal conditions, diabetes mellitus
and stomach cancers.
Clinical Trial Landscape
• Conduct of clinical trials requires prior approval
from MoH.
• Parallel submission to both MoH and EC/IRB.
• Larger tertiary hospitals have institutional ethics
committee to review clinical trial proposal.
• Clinical trial conduct is in infancy stage hence the
potential to develop is promising.
• Established research sites for vaccines trials and
HIV research.
ICON in the Country
• Presence in Vietnam since 2008.
• 2 home based CRAs covering sites in Ho Chi Minh
and Hanoi.
Services Offered
• Clinical trial application to ethics committees.
• Dossier preparation for health authority.
• Site set-up activities.
• Clinical Monitoring.
Staff Background
• CRA/SCRA with 3-5 years’ clinical monitoring
experience in Vietnam and Singapore.
In Vietnam,
clinical trial
conduct is
in infancy
stage hence
the potential
to develop is
promising.
Fast Facts
• Capital: Wellington Largest city: Auckland
• Economy/GDP: Modern, prosperous, developed
economy, nominal GDP US$128 billion, 2008
• Health Expenditure: 9.2% of GDP, 2007
• Population: 4.3 million, 2009
• Average Life span: 80 Years, 2009
• Languages: English, Maori
• Adult Literacy Rate: No longer measured
Health Trends
• A caring health system, a no fault approach and
‘cover for all’ resulting in high patient attendance
both within primary and secondary care.
• Population Disease Areas: Cardiovascular (network)
/ Diabetes / Hepatitis (network) / Hematology
(network) / Gastroenteritis (network) / Elderly /
Oncology (6 major oncology centres) / Respiratory
Disease.
• With a small population, health care professions
readily relate to their patients which encourages
active participation in clinical research;
- Smaller local communities within hospital regions
develop strong patient/research links.
- Pools of recurrent patients within specific TAs
for studies.
- Compliant patients due to familiarity with
research staff.
Clinical Trial Landscape
• Multi-region ethics system (approval 6-8 weeks).
• 45 days regulatory review and approval.
• Accepted media advertising.
• Major hospitals provide dedicated research teams
across a variety of therapy areas.
• Therapeutic area network research organisations
spanning New Zealand.
• Direct access to health care professionals.
• New Zealand Investigators are high attendees
at international conferences and are ICH / GCP
compliant.
• Good primary care network.
• Rapid study start-up.
• Sites are committed to recruiting agreed target
number of subjects.
• Sites are realistic in enrolment predictions to maintain
credibility and encourage further research within
New Zealand.
• Good subject retention rates.
• Summer January-March. No holiday season
July-September
• Early phase expertise with 2 Phase I units.
ICON in the Country
• Presence in New Zealand since 2007.
• 085/115: first country to obtain ethics approval.
• 966/003: Out of 30 countries, New Zealand was the
5th fastest recruiter per site at the study onset.
• 035/007: 1 site highest global recruiter.
• 035/006: 1 site = 3rd highest global recruiter.
Services Offered
• Project Management.
• Clinical Monitoring.
• Quality Assurance, Training, Medical Safety and
Monitoring.
• Flexible to meet any client requirements.
Staff Background
• 8 highly motivated, enthusiastic and experienced
individuals comprising an Associate Director,
Principal CRA, Senior CRA, 2 CRA IIs, an EL CRA
and 2 CTAs.
For Internal use Only
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Coordination through
Singapore Office
Contact:
Dr Grace Pei
+65 6895 8253 / +65 9295 1663
Grace.Pei@iconplc.com
Ms Juliet Mallabo-Palma
+65 6895 8203 / +65 9820 5864
Juliet.Mallabo-Palma@iconplc.com
Plaza Level, AXA Centre
41 Shortland Street
Auckland 1010
New Zealand
Contact:
Ms Debbie Wiseman
+649 363 9639 / +64 21 801 107
Debbie.Wiseman@iconplc.com

Australia
Fast Facts
Clinical Trial Landscape
ICON in the Country
For Internal use Only
• Capital: Canberra, Largest City: Sydney
• GDP / Economy: moderate-growth, low-inflation,
low interest rate economy. Nominal GDP US$1
billion, 2008
• Health Expenditure: 8.8% of GDP, 2005
• Population: 21.8 million, 2.6% represents the
indigenous population.
• Average Life Span: 84 years, 2009
• Language: English
• Adult Literacy Rate: 99%, 2009
Health Trends
• Chronic illness: a growing problem as the
population ages. 33% of residents aged 50+ years
(2004). This is projected to be up to 48% by 2050.
• Obesity poses a major risk by increasing the risk of
chronic illnesses such as diabetes, cardiovascular
disease and some cancers. 68% of adult males
and 55% of adult females are overweight / obese
and this trend is rising. Increasing diabetes, much
of it still undiagnosed. Prevalence increased from
2.4 % of population in 1995 to 3.5% in 2005.
• Cardiovascular disease - approx 35% of deaths.
Cardiovascular disease is the most expensive
health condition, costing over 5.5 billion dollars
(approx 11% of health system expenditure).
• Approx 3.5 million Australians (18%) have a
cardiovascular condition with hypertension being
most common (11%).
• Cancer - approx 25% of deaths. Prostate, colon
and breast most common cancers. Australia has
the highest rate of melanoma in the world.
• One of the highest rates of Asthma in the world,
affecting 10% of the population. Most frequent
cause for hospitalisation in children.
• 15% Australians (3.1 million) have some form of
arthritis. Largest cause of chronic pain.
• High standard of medical care in line with
USA /Europe.
• Government subsidised:
- Pharmaceutical Benefits Scheme (PBS) -
for drug therapies.
- Medicare - hospitalisation costs, tests and
procedures.
• Internationally recognised for its science,
highly trained workforce & quality of health
economic data.
• Intellectual property regime compares favorably
to the EU & US.
• Proof of concept trials may be conducted in
Australia without EU CTA or US IND.
• Comparative Phase III data generated in Australia
also of significant value for local pricing and
reimbursement activities.
• Government incentives to perform local R&D.
• Highly trained, experienced Principal Investigators
and study coordinators.
• Clinical research can take place within the public
& private hospital systems and General
Practitioner’s rooms.
• ICH/GCP compliant centres & well equipped
medical centres.
• Data acceptable for FDA and EMEA submissions.
• Expertise in using EDC, IVRS, Central Laboratories
and Imaging.
• Fewer competing studies than in US and Central
Europe. Investigator and patient availability for clinical
trials facilitates fast enrollment - cost effective.
• Good for seasonal dependent studies as patients
can be recruited during quiet times in Northern
hemisphere.
• Good where there is high disease prevalence such
as melanoma & asthma.
• 85% of patients live within 2 hours of a major
coastal city.
• Approx 12-16 weeks for EC trial approval.
• Notification only to regulatory authority in Australia
on EC approval.
• Moving to a centralised approach in Australia
to streamline process, framework based on
EU system.
• Presence in Australia since 1997.
• 2009 - 75 staff including 55 Clinical staff.
• Currently two home-based clinical staff.
• 98 studies carried out across various therapeutic
areas including 23 Oncology, 17 Cardiovascular,
14 Gastrointestinal, 11 CNS, 10 Infectious
Disease, 6 Endocrinology/Metabolism & 17 studies
in various TA’s.
Services Offered
• Project Management.
• Clinical Monitoring.
• Submission and Investigator Services and
Feasibility.
• Data Management.
• Quality Assurance.
• Training.
• Medical Safety and Monitoring.
• Business Development.
Staff Background
• 8 Project Managers with an average of 8 years’
clinical research experience.
• CRAs with clinical research experience ranging
from 1-7 years.
• Experience in Phase I-IV clinical trials.
• 3 CRAs from Australia were finalists for “CRA of
the Year” category, 2008. Two of the three CRAs
won gold and silver.
Australia is
Internationally
recognised for
its science, highly
trained workforce
& quality of health
economic data.
For Internal use Only
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Suite 201, Level 2, 2-4 Lyon Park Road
North Ryde Business Centre
North Ryde
Sydney, NSW 2113, Australia
Contact:
Colin Stanley
+61 2 98593904
Colin.Stanley@iconplc.com

India
Fast Facts
Clinical Trial Landscape
ICON in the Country
Staff
For Internal use Only
• Capital: New Delhi
• GDP/Economy: World’s 4th largest economy,
nominal GDP US$1.2 trillion, 2008
• Health Expenditure: 5% of GDP, 2006
• Population: 1.17 Billion, 2009
• Average Lifespan: 70 Years, 2009
• Languages: Official Language: Hindi.
English is primary language of education and
communication
• Adult Literacy Rate: 66%, 2008
Health Trends
• Hospitals run by government, charitable trusts &
private organisations.
• Easy access & availability to large treatment naïve
patient population with varied gene pool.
• Over 30 million people with heart diseases.
• 10 million with various Psychiatric disorders.
• 40 million diabetes patients, over 20% of the
cases worldwide.
• Highest number of patients with cancer &
malignant neoplasm.
• HIV/ AIDS epidemic a growing threat.
Cost per patient
for trials in India
is approximately
40 to 60% of
the cost in
Western nations.
• Indian Clinical Research Industry is growing at a
CAGR of 31% for the last 5 years and is predicted
to be valued at approx $360 million by 2010.
• Total Number of Clinical Trials started in India in
2008: 206.
• Cost per patient for trials in India is approximately
40 to 60% of the cost in Western nations.
• Large number of highly qualified and dedicated
medicine, pharmacology, biosciences, IT, and
clinical research professionals. Second largest pool
of scientists and engineers in the World.
• Physicians & investigators are highly qualified and
EU or US-trained.
• Established government & private teaching and
hospital institutions for clinical trial conduct.
• Many global pharmaceutical players expanded
their existing clinical research investment and
infrastructure in India to carry out Phase II and
Phase III studies.
• India offers world-class facilities to undertake
high-quality, cost-effective, Phase I, Bio-availability
(BA) and Bio-equivalence (BE) studies.
• Successful USFDA and EMEA site inspections with
no critical findings.
• Numerous sponsor audits in India are testimony to
the level of quality of data generated.
• Institutional IRB approval process can be
conducted in parallel with the DCGI review.
• More than 300 Institutions with IRBs. Most IRBs
compliant to ICH/MOH Guidelines, over 2000 ICH/
GCP compliant sites.
• Stable Regulatory Environment. Revised Schedule
Y (2005) of Drugs and Cosmetic rules (1945)
conforms to the ICH-GCP requirements, allowing
India to partake in global trials.
• Regulatory Approvals take approx 6-12 weeks. A
faster review (4-6 weeks) could happen if the study
is approved in US, Canada, U.K., Switzerland,
Germany, Australia, Japan and South Africa.
• Thorough understanding of the evolving regulatory
environment in India, as well as the US FDA, EMEA
and other global markets.
• Presence in India since 2002.
• 3 offices - Chennai, Bangalore and New Delhi.
• 15,000 square foot Central Laboratory facility
opened in Bangalore, November 2008.
• Expertise in a number of therapeutic
areas including Cardiology, Endocrinology,
Gastroenterology, CNS disorders and Respiratory
disorders. Also highly experienced in executing
Oncology trials which include Prostate Cancer,
Uterine Myoma, Lung cancers, Brain cancers,
Breast Carcinomas & Venous Thrombo Embolism
in Cancer.
Services Offered
• Clinical Trials Management.
• Interactive Voice Response System (IVRS).
• Medical Affairs and Drug Safety.
• Quality Assurance.
• Data Management.
• Biostatistics/SAS Programming.
• Regulatory Consulting.
• Investigator Contract Negotiation and Payment
Administration.
• Central Laboratory Services:
- Extensive test menu of safety, esoteric and
custom-developed assays.
- Flow cytometry and biomarker development.
- Comprehensive on-site sample management
services and storage.
- Comprehensive Logistics Support.
- Fully CAP Accredited.
- Medically knowledgeable, on-demand language
interpretation service to assist sites.
- Seamless global data management support.
• 463 employees including 16 Central
Laboratories staff.
• Average experience of staff is amongst the best
in the industry.
For Internal use Only
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Towers - Unit II
No.56/4,2nd floor
Nandidurg Road
Bangalore, India 560046
Contact:
Ms Larisa Nagra Singh
+91 80 4039 4001
Larisa.NagraSingh@iconplc.com
Dr. Anuradha Rajput
ICON Central Laboratories, Bangalore
+918040894101
Anuradha.rajput@iconplc.com

www.iconplc.com
ICON plc Corporate Headquarters
South County Business Park
Leopardstown
Dublin 18
T: +353 1 291 2000
F: +353 1 291 2700
E: info-clinical@iconplc.com
ICON has offices located throughout the world. For more information on local offices please visit www.iconplc.com
For Internal use Only Version 01/ Dec 09