e-Governance

e-Governed Clinical Trials by 2013

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In another new initiative within the e- governance framework, Indian government plans to introduce e-governance for clinical trials by 2013. Once executed this move would enable companies from any part of the world to file online applications to seek approval for clinical trials from the Drug Controller General of India (DCGI). The DCGI office would then examine the data provided online and generate queries. After validating the information given by companies, approvals for these trials can also be delivered online.

The software used would have the additional facility to split the information and send relevant data to various departments for clearances. Within this framework itself, using finger printing software, the government also intends to discourage volunteers to enroll into more than one clinical trial, as it might result in adverse drug reactions.



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