India to implement E-Governance for Clinical Trials

The health ministry of India  is planning to introduce e-governance for clinical trials in four years. The move will enable drug companies that

want to carry out clinical trials in India to register online from any part of the world. Once the required approval for conducting trials is obtained, the companies can also submit research data online to the country’s drug regulator Drug Controller General of India (DCGI), seeking marketing approval for their drug.

To maintain confidentiality, once the data is fed into the Software the software will split the information into components and no one individual would have an access to the complete information provided by a company.

“Confidentiality of the data submitted by companies would be taken care of,” the official added. The software will automatically send relevant data to various departments for clearances.

The drug regulator would deliver online approvals to companies after validating all the information submitted by companies. According to the official, it would take about four years to put the system in place and e-governance is expected to be implemented in the country by 2013.

The government also intends to make use of IT to discourage volunteers to enroll into more than one clinical trial resulting in adverse drug reactions. The government is using a finger printing software available through which clinical trial centres can be interlinked.

The drug regulator has also asked companies to install the software so that they can enroll first time volunteers and avoid drug reactions during trials.


The current economic crisis has only exacerbated an already worrisome situation in the life sciences industry. The industry has already been undergoing reformation to cut costs and improve long-term sustainability for nearly a decade. To help understand the impact on IT, Health Industry Insights, an IDC company, recently conducted a study to identify the most successful software vendors serving the life science market. The top 10 companies, based on enterprise life science software revenue, have been identified and are discussed in a new research document.


Health Industry Insights research reveals that the top 10 life science software vendor list includes both enterprise and specialty vendors. Oracle easily topped the chart in life science revenues, with SAP coming in second. While internal estimates show that Oracle and SAP were virtually tied five years ago, Oracle’s aggressive acquisition strategy has clearly paid big dividends that have helped to drive its success in the life science industry.

To read the complete press release, click here.

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