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 In India

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.

Contact

Address:
12th Floor, Prestige Khoday Towers Plot No-5, Raj Bhavan Road,
Karnataka, Bangalore
560 001 Karnataka India

Email: info@georgeclinical.com

Details

Population 1.25 billion
Official Language Hindi 41%, Bengali 8.1%, Telugu 7.2%, Marathi 7%, Tamil 5.9%, Urdu 5%, Gujarati 4.5%, Kannada 3.7%, Malayalam 3.2%, Oriya 3.2%, Punjabi 2.8%, Assamese 1.3%, Maithili 1.2%, other 5.9%, English
State Languages Patient Information/ Diaries/ Consent document will need translations into local languages that may range from 8 -11 languages depending on the site location. Major languages are – Hindi, Bengali, Gujarati, Kannada, Malayalam, Marathi, Oriya, Punjabi, Telugu, Tamil, Urdu. *Local translation vendor qualification and assessments have been performed and used currently for translation of patient materials and ICF and/or their amendments.
Hospital Records Language English
Electronic Hospital Records Only in large networks of private hospitals
In-country services Project Management
Clinical Operations
Data Management
Clinical Compliance
Medical & Safety services
Regulatory Services
Statistics