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Page 1: Excellence from design to delivery - George Clinical · PDF fileOperational hubs in Asia-Paci fi c, global investigator networks Project Systems • Data management - Merge eClinicalOS™,

Excellence from design to delivery

www.georgeclinical.com

Page 2: Excellence from design to delivery - George Clinical · PDF fileOperational hubs in Asia-Paci fi c, global investigator networks Project Systems • Data management - Merge eClinicalOS™,

Quality delivery of your trial:partner with George Clinical

George ClinicalScientifi c Leadershipand Operational Delivery

Since 1999, we have been providing a full range of trial management services to pharmaceutical and biotech customers, for both registration and post marketing trials.

Our parent organisation, The George Institute for Global Health, is a global leader in chronic disease research, dedicated to changing global medical practice and policy. George Clinical combines this scientifi c and clinical leadership with trial delivery capability to create a distinctive service.

As clinical trials’ cost and complexity continue to escalate, we provide our customers with new ways to access patient populations and ensure that your clinical trials make an impact for clinicians and patients.

George Clinical has headquarters in Sydney, Australia and employs 200 staff across 11 countries, primarily in the Asia-Pacifi c region.

We are a leading CRO in Asia, with unparalleled Investigator networks.

2 George ClinicalExcellence from Design to Delivery

Page 3: Excellence from design to delivery - George Clinical · PDF fileOperational hubs in Asia-Paci fi c, global investigator networks Project Systems • Data management - Merge eClinicalOS™,

George ClinicalExcellence from Design to Delivery 3

Page 4: Excellence from design to delivery - George Clinical · PDF fileOperational hubs in Asia-Paci fi c, global investigator networks Project Systems • Data management - Merge eClinicalOS™,

George Clinical’s operational staff have a wealth of experience in conducting clinical research across Asia-Pacifi c. As an organisation, we have delivered studies that not only enabled registration of drugs, but also changed medical practice and policy. All of our management team have extensive experience within large pharmaceutical companies and/or global CROs. Our experience spans major therapeutic areas and all phases of clinical research.

Operational Excellence

George Clinical adds scientifi c engagement and leadership to the conventional contract research organisation (CRO) model. We deliver exceptional recruitment, retention and quality at a competitive cost through enhanced scientifi c engagement.

Drug development costs has risen dramatically. At the same time requirements for quality, integrity and transparency in clinical trials have also increased. We have evidence that enhanced scientifi c engagement from study design through trial management delivers stronger study performance. This will deliver the paradigm shift needed towards cost effi cient, impactful results from your clinical trials.

Scientifi c Impact

Scientifi c ImpactOperational Excellence

CRO professionals and scientifi cthought leaders in your project team

4 George ClinicalExcellence from Design to Delivery

Page 5: Excellence from design to delivery - George Clinical · PDF fileOperational hubs in Asia-Paci fi c, global investigator networks Project Systems • Data management - Merge eClinicalOS™,

81% Cardiovascular71% Diabetes60% Renal/Genitourinary58% Oncology - Solid Tumours47% Respiratory - Asthma & COPD45% CNS37% Infectious Diseases33% Rheumatology33% Endocrinology & Metabolism32% Pain25% Gastroenterology 25% Oncology - Hematology

Percentage of staff with experience in:

George ClinicalExcellence from Design to Delivery 5

Page 6: Excellence from design to delivery - George Clinical · PDF fileOperational hubs in Asia-Paci fi c, global investigator networks Project Systems • Data management - Merge eClinicalOS™,

George Clinical provides comprehensiveclinical trial management servicesFor global studies, we have established relationships with research organisations in Europe and North America. We have delivered an impressive array of large global studies through this network.

Asia-Pacifi c Services

• Project management

• Site management & monitoring

• Safety and endpoint management

• Regulatory services

• Quality management

• Quality assurance

Global Services

• Protocol development & scientifi c leadership

• Medical monitoring

• Data management

• Statistical analyses

• Health economics

• Endpoint and DSMB committees

PragueLondon

RaleighSan Diego

6 George ClinicalExcellence from Design to Delivery

Asia-Pacifi c Focus,Global Reach

Page 7: Excellence from design to delivery - George Clinical · PDF fileOperational hubs in Asia-Paci fi c, global investigator networks Project Systems • Data management - Merge eClinicalOS™,

Operational hubs in Asia-Pacifi c, global investigator networks

Project Systems

• Data management- Merge eClinicalOS™, Medidata Rave®, Oracle® and Medrio

• CTMS

• eTMF

• Safety database

• Endpoint managment

George Clinical is headquartered in Sydney, Australia, with offi ces in China, India, Hong Kong, Taiwan, Korea, Malaysia, New Zealand, USA and the United Kingdom. From these hubs and our partner organisations in Korea and Japan, we have access to other key countries in Asia and beyond.

New Delhi

Bangalore

Beijing

Harbin

ChengduShanghai

Seoul

Tokyo

Hong Kong Taipei

Sydney

Kuala Lumpur

Manila

Auckland

George ClinicalExcellence from Design to Delivery 7

Page 8: Excellence from design to delivery - George Clinical · PDF fileOperational hubs in Asia-Paci fi c, global investigator networks Project Systems • Data management - Merge eClinicalOS™,

Our trials are renowned for changing mmeans you get meaningful results f

8 George ClinicalExcellence from Design to Delivery

Page 9: Excellence from design to delivery - George Clinical · PDF fileOperational hubs in Asia-Paci fi c, global investigator networks Project Systems • Data management - Merge eClinicalOS™,

medical practice, which from your R&D spend

Experience with Scientifi c Impact

Our mission is to improve the health of millions of people worldwide by creating scientifi c impact and effecting real change in medical practice and policy.

• Experience: In-depth knowledge of what is needed to deliver effi cient clinical trials.

• Expertise: Unparalleled knowledge in chronic disease, particularly cardiovascular, diabetes, nephrology, stroke and respiratory disease.

• Reach: Focused on the Asia-Pacifi c region, with teams in emerging and established markets.

George Clinical understands the requirements of transforming clinical trial data into medical practice and policy. Our organisation aims to maximise scientifi c impact with high cost effi ciency. We apply our experience in study design and methodologies to maximise results from your R&D spend.

Our mission is to improve the health of millions of people worldwide.

Our networks in Asia-Pacifi c are unparalleled in the areas of cardiovascular, diabetes, nephrology, stroke and respiratory disease. We have established relationships and in-depth knowledge of the capability of each site.

We have established centres in major cities however our reach extends to both developing and rural areas, giving our customers access to a greater pool of patients.

Working with our Networks

George ClinicalExcellence from Design to Delivery 9

Page 10: Excellence from design to delivery - George Clinical · PDF fileOperational hubs in Asia-Paci fi c, global investigator networks Project Systems • Data management - Merge eClinicalOS™,

This model combines best practice in operations and timelines with credible scientifi c engagement to provide our customers with the best of both worlds.

Our scientifi c teams include in house researchers and selected local thought leaders. Working alongside our operational team they:

• Provide our customers with strong links to specifi c disease communities in each country

• Leverage in-depth knowledge of study sites and their capabilities

• Work closely with the study operations team to facilitate Investigator liaison

• Promote training, quality, recruitment and retention through peer to peer interactions.

Unlike a conventional CRO, our site interaction is built upon peer to peer relationships with our international researchers, within each study team. Experience has taught us that Investigators are more motivated when they embrace the study’s scientifi c rationale and the impact on them and their patients.

Motivated Research Teams

Peer to Peerengagement

Our Operational Model

Integratedproject team

with day today interaction

SCIENTIFIC LEADERS OPERATION TEAMS

Sites

Identificationand scientificcommunication

Implementationand operationalcommunication

10 George ClinicalExcellence from Design to Delivery

Page 11: Excellence from design to delivery - George Clinical · PDF fileOperational hubs in Asia-Paci fi c, global investigator networks Project Systems • Data management - Merge eClinicalOS™,

George ClinicalExcellence from Design to Delivery 11

Page 12: Excellence from design to delivery - George Clinical · PDF fileOperational hubs in Asia-Paci fi c, global investigator networks Project Systems • Data management - Merge eClinicalOS™,

Australia

Level 3, 50 Bridge StreetSydney, NSW 2000AUSTRALIA

T +61 2 8052 4300F +61 2 8052 4301

China - Beijing

Room 1802, Tower B, Horizon TowerNo. 6 Zhichun Road, Haidian DistrictBeijing 100088CHINA

T +86 10 8280 0577F +86 10 8280 0177

China - Shanghai

2223,22/F Tomson Commercial Building,710 Dongfang Road, Shanghai, 200122 CHINA

T +86 21 6165 2200F +86 21 6165 2286

Hong Kong

Units 4305–06, Tower 1, Metroplaza233 Hing Fong RoadKwai Fong, New TerritoriesHONG KONG S.A.R

T +85 2 3104 2492F +85 2 3105 0068

India - Bengaluru

‘Nova Miller’4th Floor, Thimmaiah RoadVasanth NagarBengaluru 560 052 KarnatakaINDIA

T: +91 80 4942 1400F: +91 80 4942 1426

Korea

97 Toegye-RoCoryo Daeyungak Tower 16th FL.Jung-Gu, Seoul 04535KOREA

United Kingdom

Centrum House36 Station RoadEgham, SurreyTW20 9LFUNITED KINGDOM

T +44 17 8449 7100

United States of America

1340 Environ Way, Chapel Hill North Carolina, 27517 USA

T +1 91 9609 2197

Malaysia

Unit 902, Level 9Uptown 2 No 2 Jalan SS 21/37Damansara Uptown 47400Petaling Jaya, SelangorMALAYSIA

T +60 3 7610 0725 F +60 3 7610 0726

New Zealand

Level 14 PwC Tower188 Quay StreetAuckland, 1010NEW ZEALAND

T +64 7 867 7995

Taiwan

4F, No. 200, Sec. 1Keelung Road, Taipei 110TAIWAN

T +886 2 7725 3600F +886 2 7725 3621