Emerging Markets

India

PRA has been operating in India since 2006. From our office in Mumbai, we offer the following services:

• Project management
• Clinical monitoring
• Feasibility studies
• Site selection and validation
• Submissions with EC/IRB and regulatory authorities
• Identification of service providers (central laboratories, translators, drug depots)

Country Advantages: India

• Fast recruitment and study start-up
• Population over 1.2 billion, where a third is concentrated in urban areas
• Access to treatment-naïve patients across various indications
• Medical, regulatory and site communications in English
• Medical professionals are highly educated and many have studied in the US and Europe
• Majority of sites in India are trained in GCP — as mandated by Government
• Common diseases of developing and tropical countries as well as cardiovascular and neurological diseases; diabetes; cancer; psychiatric illnesses; and infectious diseases, including AIDS
• Changes to the regulatory and administrative structure within the office of the Drugs Controller General India (DCGI) have significantly improved the ease and efficiency of conducting clinical trials in India

PRA has the local knowledge, investigator relationships, expertise and experience that you need to run a successful trial in India.

For more information on how PRA can make your next India clinical trial a success, please contact us via email at endpoints@praintl.com.