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 has a long history in the sub-continent. We have extensive experience working in both urban and rural areas of India. With over 500 sites and over a billion people – including a vast treatment-naïve clinical 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. Indian clinical research professionals are well-trained and qualified with excellent English skills.
India’s regulatory environment has improved significantly over the last few years. They are highly experienced in international clinical trials and many sites have been inspected by USFDA, MHRA, EMEA and other regulatory agencies. As such this makes India, once again, a highly attractive destination for clinical trials.
India has been conducting global studies for over 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 (Schedule Y and its amendments).
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.
Central Nervous System 26%
Medical Devices 19%
|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
|GDP – per capita (US $)||$6,200|
|Health Expenditures||4% of GDP|
India has been predominately well experienced in conducting clinical trials over several decades and most recently supported the regulatory governance, becoming more transparent. There are some factors, which have made this enabling in India. Primarily we have a large patient population that’s helping speedy recruitment, also helping in higher retention rate of the participants and the access to highly qualified PIs across various sites, also the reliability of the data of the study outcome over the years has made it more or less compatible with the data that is coming out of globally conducted trials. So all these go a long way in making India a very promising destination for clinical trials
George Clinical in India, we’re completing nine years, and we have about 55 staff spreading across various services like project management, clinical operations, data management and these have wide range of experience across various therapeutical areas in India.
George Clinical in India is basically capable of offering the entire spectrum of clinical development services, which ranges right from project management, clinical data management, project operations. We have also services relating to regulatory services, compliance, quality, and so it’s a wide spectrum and we are able to design and deliver the services depending on what the sponsor’s needs are.
I think the rapport and relationship between the CRO and the sites is going to very crucial for efficient execution and coordination for the study management and India being a culturally diverse country with multiple languages across various states, it is going to be helpful to have somebody on the ground to coordinate and being the point person on the ground to facilitate the study trials. Also the local presence is going to help a long way in interfacing and appreciating the regulatory aspects and interactions with the regulatory bodies is also going to be very helpful with the person on the ground and that is going to be very helpful to enable the interactions and strategize the study design.
Yes true. There has been several regulatory issues in the past and these have actually kind of blocked out the clinical trials market for some time, a few years back. But with the changing scene on the regulatory front, more recently from 2013, this is again opened up the avenues for the clinical trials industry in India and the concerns have been primarily around the lines of transparency in the terms of regulatory guidelines, how you ensure patients safety and how the informed consent and compensations and there’s been concerns from the public interest on these areas. So there has been efforts on the regulatory front to address these, and more recently, there has been transparent guidelines provided, which has helped to open up the market and now the regulations are more transparent and they’re guiding in terms of providing specific areas of how the informed consent has to be taken. There is also the audio video consenting that has been introduced. Also the ethical operations aspects has been focused on. For example, if a feasibility study has to be evaluated, there are three criteria’s that are generally looked that, whether it is meeting the unmet medical needs of the patient population relevant to India or is it an innovation versus an existing therapeutical area that is being looked at in that study or is it, in terms of the risk versus benefit to the patient’s safety. So these are various aspects that are evaluated and the regulatory bodies are getting around providing guidelines and making it enabling. So the very intent of these changing scenarios on the regulatory front is helping India to become a destination for having these trials and more recently last year we’ve had several more measures that have been introduced and some more in the pipeline like accreditation of the ethics committee and the sites, which is definitely promoting India as a reliable destination for global clinical trials.
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