INDIA |
The tremendous population (1.1 billion) and density in India allows for a large number of patients per site, regardless of the condition being studied. Let Pharm-Olam perform a feasibility for your study indication at several of the largest centers to determine the actual incidence and patient availability within their large patient base. The standard of care for many indications in India is essentially identical to that in the United States and Western Europe, considering that most of their medical personnel are trained in very modern, westernized medical schools and frequently undergo residencies or fellowship in the United States, Western Europe, or Australia. All regulatory documents for clinical trials are submitted in English. Only the patient informed consents and patient information leaflets need to be translated into two or three dominant local languages. Physicians and medical staff are fluent in English and even routine medical documents are recorded in English to ICH/GCP quality standards. Sponsors can handle their Indian trial communications with Pharm-Olam's corporate offices in U.S. or U.K. avoiding problem with time zone differences. |