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.
|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
Medical & Safety services