Singapore

Singapore is a recognized destination for clinical trials with multi‑ethnic populations.

Singapore is a recognized destination for clinical trials with multi‑ethnic populations including 74% Chinese, 13% Malay and 9% Indian.

Similarly, to what George Clinical provides in Hong Kong and Taiwan, Singapore offers regulatory services which includes acting as local sponsor while managing IP importations, project management, safety and pharmacovigilance (PV) reporting services.

Key advantages of conducting clinical trials with George Clinical in Singapore include a well‑established regulatory and ethics review framework; fast approval due to the Health Sciences Authority (HSA) adopting a risk‑based approach in the regulations of clinical trials of therapeutic products; and paperless submissions. Commercially, clients also have the convenience of doing business in the Asian market where English is the official language.

What are the benefits of conducting clinical trials in Singapore?

  • Short start‑up timeline of 3‑4 months
  • Well‑established RA and EC framework
  • The majority of institutions have clinical trial centers which can assist in the set‑up and coordination of clinical trials
  • High‑quality data and experienced GCP‑trained clinical trial staff
  • Experienced key opinion leaders (KOLs) including a renal scientific leader in‑country

Why is George Clinical the CRO of choice for our sponsors in Singapore?

  • We have established a presence and office with local representation
  • Experienced team with various functional heads with extensive industry experience
Singapore: #32-01, 300 Beach Road, The Concourse Singapore, 199555, Singapore

Philippines

The Philippines offers a strong track record in the conduct of infectious diseases, oncology, metabolic disorders, respiratory and cardiovascular trials.

George Clinical’s Philippines office is based in the capital city, Manila and compliments the organization’s list of global locations. Currently, the Philippines has a population of more than 100 million making it a rich source of patients with a high probability of recruiting treatment‑native population.

Key advantages of conducting clinical trials with George Clinical in the Philippines include its high literacy rate with people fluent in the English language; wide network of hospitals and medical centers covering more than 17 regions; commonly lower cost of conducting clinical trials in comparison to other Asian countries; and most physicians in the Philippines have received US‑based training and experience.

Historically, the Philippines has a particularly strong track record in the conduct of infectious diseases, oncology, metabolic disorders, and respiratory and cardiovascular trials. George Clinical has an extensive track record in chronic disease trials that correlates directly with the most prevalent indications in the country.

Why is the Philippines attractive for sponsors to conduct clinical trials?

  • Accredited local institutional review boards (IRBs)
  • Trained Investigator and site staff with global clinical trial experience
  • Large patient pool for targeted therapeutic areas

Why is George Clinical the CRO of choice for our sponsors in the country?

  • Presence of a local team that is familiar with local regulations and requirements
  • Experienced team managing Phase II to IV studies
Philippines: 9th Floor, V Corporate Center, Salcedo Village, 125 L.P. Leviste Street, Makati, 1227 Metro Manila, Philippines

Australia

Australia has a rich research environment, highly experienced investigators and research professionals, coupled with excellent health care infrastructure and a strong intellectual property regime.

Australia has a longstanding history of conducting clinical trials to a high standard.

Australia has a rich research environment, highly experienced investigators and research professionals, coupled with excellent health care infrastructure and a strong intellectual property regime. Many Australian investigators and researchers are world leaders in their field. There are many attractive features of research and development in Australia. Notably, current efforts to simplify the ethics approval process is ongoing. A new clinical trials website and a register for clinical trial participants also aim to facilitate the recruitment of subjects in Australia. Australia does not require full regulatory submission and approval for the conduct of clinical trials. Rather, it uses a notification process only which significantly reduces the time required to set up and start a clinical trial.

The Australian government also provides financial support to research through the R&D tax incentive, which provides either ‘cash back’ or tax offsets to R&D spend – ask us how to make the most of this incentive.

What are the benefits of conducting clinical trials in Australia?

  • High‑quality research and facilities
  • Investment incentives (tax incentive)
  • Diverse participant recruitment pool
  • Healthcare environment (health care system similar to US, UK and Europe)
  • A number of phase I units that can recruit healthy subjects and patients
  • Many Australian investigators and researchers are world leaders in their field
  • Australian government provides financial support to research through R&D tax incentive

George Clinical the CRO of choice in Australia

George Clinical is the CRO of choice for all phase studies in Australia as George Clinical can conduct both early and late phase studies utilizing its close ties to thought leaders through its Scientific Leadership services. George Clinical allows sponsors to use the same CRO to run their clinical trial programs from early to phase studies. With George Clinicals established teams in Asia, North America and Europe, sponsors are able to leverage Australia as a launchpad into all these regions.

Australia: Level 19, Suite 19.01, 323 Castlereagh St, Sydney, NSW 2000, Australia

New Zealand

New Zealand offers a world class track record in early phase trials, proof of concept trials and independent, clean and precise clinical data.

New Zealand requires only one ethics committee review per study – reducing clinical trial start‑up timelines.

New Zealand has a respected reputation in medical research and is a place of innovation, honesty and entrepreneurial advancement. New Zealand offers a world class track record in early phase trials, proof of concept trials and independent, clean and precise clinical data.

New Zealand was the first country in the world to establish an electronic Population Health Index, a system that features a large database that contains approximately 20 years of health encounters and is now accompanied by an equally comprehensive Health Practitioner Index.

Sponsors who wish to conduct clinical trials in New Zealand simply make an application to Medsafe and Health and Disability Ethics Committees (HDECs), seeking permission to conduct a clinical trial in New Zealand and adhere to ongoing regulatory reporting procedures. Only one ethics committee review is required per study, which covers all sites. The process is simple and approximately takes 4‑6 weeks from submission to full approval. Furthermore, Medsafe’s Standing Committee On Therapeutic Trials (SCOTT) approval process takes a maximum of 45 days (typically less). This process is not required for medical devices or new indications of New Zealand registered formulations; however, it is necessary for non‑registered drug formulations.

New Zealand’s one ethical committee approval process does not require US FDA IDE filing prior to a study. As a result, sponsor’s wishing to develop medical devices for a rapid, cost‑effective means and gaining early proof of concept, should consider conducting their initial clinical trials in New Zealand.

What are the benefits of conducting clinical trials in New Zealand?

  • Trials in New Zealand are increasingly cost‑effective as a result of pass through costs that are lower and considerable without sacrificing quality.
  • New Zealand consists of a diverse ethnic sub‑population
  • New Zealand has a southern hemisphere advantage of reverse seasonality, boosting international recruitment

George Clinical the CRO of choice in New Zealand

George Clinical is the CRO of choice for all phase studies in New Zealand as George Clinical can conduct both early and late phase studies utilizing its close ties to thought leaders through its Scientific Leadership services. George Clinical allows sponsors to use the same CRO to run their clinical trial programs from early to phase studies. With George Clinicals established teams in Asia, North America and Europe, sponsors are able to leverage New Zealand as a launchpad into all these regions.

New Zealand: Level 14 PwC Tower, 188 Quay Street, Auckland, 1010, New Zealand

China – Beijing

George Clinical’s largest hub outside the head office of Sydney, offering full CRO services and a site network that spans the country.

China is George Clinical’s largest hub outside the head office of Sydney, offering full CRO services and a site network that spans the country.

With its large potential for patient recruitment and a rapidly growing pharmaceutical market, China – currently, the second largest in the world, is an obvious choice for many when entering the Asian market.

The Chinese healthcare delivery system consists of public hospitals and community healthcare centers, with an increasingly private care system. Recent NMPA (CFDA) changes in the regulatory environment have reinforced the need for quality data to be both verifiable and transparent with an increasing acceptance of ICH GCP standards. A complete overhaul of the regulatory process in July 2018 was undertaken to encourage innovation and shorten CTA approval times to 3 months. Additionally, truly innovative molecules may also apply for expedited approval shortening CTA approval times to as little as 2 months. A similar overhaul of the registration process has also been undertaken for medical devices and IVD products. These changes are significant and make China an increasingly attractive destination for trials.

George Clinical has been conducting clinical trials in China since 2007 with an extensive network of over 360 trial centers in 60 cities for Phase I‑IV trials.

What are the benefits of conducting clinical trials in China?

  • China has access to a large patient pool
  • Potential for treatment naïve patients, especially in oncology
  • Rapidly developing medical infrastructure in urban centers and centers of excellence for many common diseases such as hypertension, diabetes, oncology, and renal disease
  • Lower operational costs

What are the most prevalent diseases in China?

  1. Stroke
  2. Ischaemic heart disease
  3. Chronic obstructive pulmonary disease
  4. Cancers
  5. Road injury
  6. Hypertension
  7. Diabetes mellitus
  8. Lower respiratory infections
China - Beijing: Room 2305-2307, 23/F, GUORUI Plaza A, No.1 Ronghua SouthRoad, Beijing Economic and Technological Development Area, Beijing, 100176, P.R. China

China – Shanghai

China - Shanghai: WeWork, Room17-107 China Overseas 838 S.Huangpi Road, TWR B Huangpu, Shanghai, China

India

George Clinical in India capable of offering the entire spectrum of clinical development services, including project management, clinical data management and project operations.

George Clinical’s long history in the sub‑continent includes extensive experience working in both urban and rural areas of India. With more than 500 sites and 1.4 billion people – including a vast treatment-naïve population and clinical development cost far lower than Western countries – India is an ideal destination for clinical trials. Many sites also have state‑of‑the‑art facilities and well‑trained clinical research professionals with excellent English skills.

India’s regulatory environment has improved significantly over the last few years. The New Drugs Clinical Trial Rules (NDCT) formalized in 2019 are balanced and well received by the global research community. Many of the sites are experienced and understand the requirements of conducting international clinical trials. Sites have been inspected by USFDA, MHRA, EMEA and other regulatory agencies in the past which demonstrates that quality clinical trials are being conducted in India and data from India are being accepted by regulatory authorities. These elements make India a highly attractive destination for clinical trials.

India has been conducting global studies for more than 30 years. Several guidelines provide the framework for clinical trial conduct in India, such as the Indian Good Clinical Practice, the Indian Council of Medical Research ethical guidelines and clinical trial‑related drug laws (NDCT 2019).
The cost to conduct a trial in India is estimated to be 40 to 70 percent lower compared to the United States or European Union.

What are the benefits of conducting clinical trials in India?

  • The favorable and well‑balanced regulatory environment
  • A genetically diverse population pool of over 1.4 billion has patients with unmet medical needs.
  • Standard of care is aligned to Western medical practice which enables easier global clinical trial conduct and thereby better adherence to protocol, patient safety and compliance.
  • Well‑trained medical community with thousands of English‑speaking investigators trained in western countries and actively collaborating with international medical societies.
  • Over 700,000 specialty hospital beds from 221 medical colleges with English‑speaking medical and paramedical health professionals
  • The rising burden of non‑communicable diseases in therapy areas such as cancer, cardiovascular diseases, diabetes, chronic respiratory diseases, mental health, neurological disorders, and chronic kidney disease.
  • India’s contribution to global clinical trials enables shorter recruitment timelines and equitable contribution to global recruitment strategy.
  • Lower trial costs than most other global regions.
  • English‑speaking life sciences workforce aligned to global work practices ensures comprehendible and seamless communication with different global clinical trial stakeholders.
India: 12th Floor, Prestige Khoday Towers Plot No-5, Raj Bhavan Road, Bangalore, Karnataka, 560 001, India

Hong Kong

Hong Kong is George Clinical’s East Asia hub, overseeing our operations in Taiwan and Malaysia.

Hong Kong is George Clinical’s East Asia hub, overseeing our operations in Malaysia, Singapore, South Korea, Taiwan, Thailand, Philippines, Indonesia and Vietnam.

Hong Kong has a long history of international research with sophisticated infrastructure and resources across all phases. A small, densely populated area, Hong Kong’s world‑class hospitals offer excellent recruitment potential. Hong Kong has a long and impressive track record of conducting global clinical trials. Since the introduction of ICH GCP in 1996, Hong Kong has participated in over 1000 global clinical trials. Hong Kong has had a history of high‑quality clinical research output and plays a role in scientific leadership in Asia.

Hong Kong has excellent infrastructure in terms of transportation, workforce and legal framework. Hong Kong has an outstanding healthcare system, as indicated by one of the lowest infant mortality rates and the longest life expectancy in the world. There are 42 public hospitals that provide 90% of the medical care in Hong Kong.

Hong Kong is officially recognized by China State Food and Drug Administration for conducting clinical trials for drug registration purposes in mainland China in certain therapeutic areas. There is strong government support for clinical research, with the recent example being the set up of two Phase I centers at leading teaching hospitals in Hong Kong.

Clinical trial data from Hong Kong can be used to file new drug applications, making Hong Kong a gateway to mainland China.

What are the benefits of conducting clinical trials in Hong Kong?

  • Fast approval timeline of 3‑6 months
  • Clinical data from Hong Kong is recognized globally
  • Two‑Phase 1 Clinical Trial Centers (both accredited by CFDA)
  • Hong Kong data can be used to file New Drug Application in CFDA
  • Unrestricted import and export of biological specimens
  • Developed infrastructure
  • A strong presence of academic institutions
  • High‑quality investigators
  • English as the official language

Why is George Clinical the CRO of choice for our sponsors in Hong Kong?

  1. Well established site network
  2. Experienced team on local regulations requirement
  3. Engagement with key opinion leaders (oncology and renal scientific leaders)
Hong Kong: Units 4305-06, Tower 1, Metroplaza, 223, Hing Fong Road, Kwai Fong, New Territories, Hong Kong

Taiwan

With a strong growth market for drug development, dense population, and a universal healthcare system, Taiwan is an ideal location for clinical trials.

Taiwan is one of George Clinical’s fastest‑growing Asian hubs. With a strong growth market for drug development, a dense population, and a universal healthcare system, Taiwan is an ideal location for clinical trials. George Clinical’s on‑the‑ground clinical team leader oversees a number of our CRAs and CTAs in delivering customer projects across Taiwan. The Center for Drug Evaluation (CDE) was established by the Ministry of Health and Welfare (MOHW) to assist the Taiwan Food and Drug Administration (TFDA) in the technical review of new drugs, medical devices and clinical trials to fulfill regulatory requirements.

The MOHW regularly accredits sites for clinical trial conduct, where the certificate is valid for four years. There are 128 qualified sites for conducting clinical trials in Taiwan. Known centers for excellence include the National Taiwan University Hospital, which currently runs more than 600 clinical trials, including 43 Phase I clinical trials; and Chang Gung Memorial Hospital, which currently runs more than 500 clinical trials. There is strong government support for clinical trials.

What are the benefits of conducting clinical trials in Taiwan?

  • Taiwan is a strong growth market for drug development
  • Approximately 80% of trials in Taiwan are multinational trials
  • Almost 100% of Taiwanese nations are covered by the National Health Insurance (NHI) program, which provides universal quality healthcare to its population at an affordable cost
  • Clinical Trial Notification and c‑IRB Mechanisms provide a fast study start‑up timeline

Why is George Clinical the CRO of choice for our sponsors in Taiwan?

  • Experienced team managing Phase I to IV clinical trials.
  • Established network
Taiwan: Level 37, Taipei 101 Tower, No.7, Section 5, Xinyi Road, Taipei City, 110, Taiwan

Malaysia

Malaysia is George Clinical’s Southeast Asian hub, where we cover neighboring countries of Singapore, Indonesia and the Philippines – accessing a population of almost 400 million multi‑ethnic people.

Malaysia is George Clinical’s Southeast Asian hub, where we cover neighboring countries of Singapore, Indonesia and the Philippines – accessing a population of almost 400 million multi‑ethnic people.

Singapore is a recognized destination for clinical trials, yet other countries are fast emerging as more governments commit to streamlining their clinical research industry. Malaysia implements a universal healthcare system that co‑exists with a private healthcare system. Malaysia has a multi‑ethnic population of over 30 million, with moderate life expectancy and infant mortality rate. The government has committed funding to improve the healthcare systems in order to support medical tourism and clinical research. The network of Clinical Research Centres, as well as Clinical Research Malaysia, is part of the government effort to improve the country’s infrastructure to support the industry. To date, Malaysia has 90 industry‑sponsored research (ISR) trial sites which are approved by the Ministry of Health (MOH) and local IRBs/ IECs, consisting of 11 prime sites network. They are a mixture of public, teaching and private hospitals, and have participated in over 1,000 ISR trials that require ICH GCP compliance.

Why is the country attractive for sponsors to conduct clinical trials?

  • The current Malaysian Economic Transformation Program (ETP) targets clinical research as one of its main drivers in economic growth. Therefore, the government of Malaysia established Clinical Research Malaysia (CRM) with the aim of promoting an increase in the number of clinical trials in Malaysia.
  • CRM supports the clinical research industry to effectively increase the speed, reliability, and delivery of outcomes for all stakeholders involved.
  • Malaysia has inherent benefits to conduct clinical trials such as its large multi‑ethnic population that offers genetic diversity
  • Established and good public and private healthcare systems
  • A consistently increasing number of Good Clinical Practice (GCP) trained and compliant investigators and support staff
  • An established and comprehensive ethical review process by ethics committees
  • Adherence to intellectual property rights (IPRs) and competitive trial costs compared to other Asian countries.
  • Malaysia also boasts shorter regulatory and ethics approval timelines for ISR that are comparable with countries like Hong Kong, Japan, Singapore, Taiwan and South Korea
  • Malaysia ranks high globally with one of the best start‑up timelines

Why is George Clinical the CRO of choice for our sponsors in Malaysia?

  1. Established in‑country network
  2. Experienced staff on local regulations and requirement
  3. Engagement with key opinion leaders (KOLs) across various therapeutic areas
Malaysia: Unit 902, Level 9, Uptown 2 No. 2 Damansara Uptown, Jalan SS 21/37, Damansara Utama, Petaling Jaya, 47400, Selangor Malaysia

South Korea

South Korea is a recognized hub for clinical research in the Asian region, with more clinical trials recorded than any other Asian country between 2001 and 2012.

South Korea is a recognized hub for clinical research in the Asia Pacific region, with more clinical trials recorded than any other Asian country between 2001 and 2017.

There are many government support structures for conducting research in Korea. This, coupled with a sophisticated infrastructure, a large population and a market size of approximately USD 20 billion, Korea attracts a large number of industry sponsors. Strong government support exists to encourage clinical trials in Korea.

Korea is the leading clinical trial destination in the Asian region. Between 2001 and 2012, Korea had the highest number of clinical trials compared to other Asian countries. Approximately 45 % of clinical trials in Korea are multinational trials.  There is strong government support to develop Korean clinical trial capacity and capability, and in particular to train clinical trial professionals and develop world‑class sites.

The regulatory body responsible for administering the regulatory framework in Korea is the Ministry of Food and Drug Safety (MFDS). The MFDS has a policy of encouraging global trial participation and simultaneous global registration, which is evident from the many government incentives to promote international clinical trials. Only sites accredited by the MFDS may conduct clinical trials. There are more than 180 accredited sites in Korea.

What are the benefits of conducting clinical trials in South Korea?

  • Leading clinical trial destination in the Asian region
  • Between 2001 and 2017, Korea had the highest number of trials compared to other Asian countries
  • Approximately 80% of clinical trials in Korea are multinational trials
  • Fastest study start‑up times in Asia, with well‑defined regulatory and review processes
  • Accelerate study start‑up timeline
  • Well‑established clinical research sites and well infrastructure
  • Globally recognized KOLs
  • Good track records in recruitment

Why is George Clinical the CRO of choice for our sponsors in Korea?

  • Well‑established site network
  • Experienced team on local regulations requirement
  • Engagement with key opinion leaders (oncology and renal)
South Korea: 4th FL, S&M Building, 120 Myeongdal-ro, Seocho-dong, Seocho-gu, Seoul, 06658, Republic of Korea

Europe

Europe has a consistent reputation for quality research.

Europe enjoys a consistent reputation for quality research and has some of the best healthcare systems in the world.

Consisting of >50 countries, Europe has a very large and diverse patient population with access to private, academic and national hospitals.

In comparison with the healthcare systems of other developed nations, the UK’s National Health Service (NHS) is rated as one of the best. The Department of Health created the National Institute for Health Research to establish a high‑end health system within the NHS. The Clinical Research Network is part of this organization.

The Clinical Research Network provides a good infrastructure to support clinical research in the UK and the European Union, and provides support including identifying and recruiting patients, providing training so that researchers have access to experienced people.

What are the benefits of conducting clinical trials in the UK?

  • Large patient population across Eastern and Western Europe
  • Centralized submission process for clinical trials
  • In comparison with the healthcare systems of other developed nations, the UK’s National Health Service (NHS) is rated as one of the best
  • Clinical Research Networks (CRN) provide a good infrastructure to support clinical research
  • The CRN provides support including identifying and recruiting patients, providing training so that researchers have access to experienced people

What are the prevalent diseases in the UK?

  1. Cancer
  2. Heart disease
  3. Stroke
  4. Respiratory disease
  5. Liver disease
Europe: George Clinical (UK) Ltd – Menzies LLP, 2nd Floor, Magna House, 18–32 London Rd, Staines-Upon-Thames, TW18 4BP, United Kingdom

The United States – Kansas City

George Clinical, the leading Asia‑Pacific CRO, continues to expand its presence in the USA beyond oncology but also in renal, vascular and neurology therapeutic areas.

Headquartered in Sydney, Australia, George Clinical has offices in China, India, Hong Kong, South Korea, Taiwan, Malaysia, New Zealand, United Kingdom, and multiple offices in the USA.

Over the years, George Clinical has grown rapidly across the Asia‑Pacific region and is continuing to develop its global operations. The combination of a strong commercial proficiency and clinical research and scientific excellence positions George Clinical as a high quality, global CRO with substantial clinical and scientific assets.

George Clinical’s operations now expand further in the USA, with nearly 100 people and leaders specializing in oncology, renal, vascular and neurology trials. We offer full‑service capabilities for the clinical trials we manage for our important clients. We are here to support our USA customers with their clinical trial and scientific leadership needs and to lead trials across our core operational facilities in the Asia‑Pacific and European regions.

What are the benefits of conducting clinical trials in the United States?

  • Excellent regulatory conditions and quick start‑up for clinical trials
  • Access to well‑trained investigators in all therapeutic areas
  • Clinical trials incorporated into the health care model
  • Largest pharmaceutical market in the world

What are the prevalent diseases in the United States?

  1. Oncology
  2. Renal Disease
  3. Vascular Disease
  4. Numerous Neurological conditions
The United States - Kansas City: 10975 Benson Dr, Suite 200, Corporate Woods, Building 12, Overland Park, Kansas City, 66210, USA

The United States – Memphis

The United States - Memphis: 1755 Kirby Parkway, Suite 310, Memphis, Tennessee, 38120, USA