iGate Planning To Adopt EDC And RDC To Discipline Data Validation

iGate Clinical Research has a three-tier IT architecture and is mulling to migrate the Elecpron software it uses for clinical data management to .NET technology. To avoid duplication of data and enhance the investigators’ efficiency, there are also plans to adopt EDC and RDC. In conversation with Biztech2, Naveen Shetty, manager - IT, iGate gives details about the IT infrastructure and the role of IT in the pre-clinical and clinical research stages at iGate.

What is the information architecture at iGate Clinical Research?

We have a three-tier architecture- the core switch and access switch to fit into the clinical research domain.

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For LAN, we have designed VLANs to have internal security and increase the bandwidth and performance of LAN. We have all the redundancy for every LAN connectivity i.e. 1000 Mbps.

The Mumbai office is connected on WAN with iGate Global Solutions in Bangalore via 512 Kbps lease line connectivity as well as ISDN at the back up. We have a 6251 firewall in Mumbai and are already into the internal network zone of iGate Global Solutions in Bangalore.

The web server is located at the US office and replicated at iGate Global. There is also a web server in Mumbai specially designed for the Intranet that falls in the de-militarised zone of the firewall. Other than this, the web servers that we have are designed for our clients in the Mumbai office, published on our web server.

On the server level, we have a database SQL server 2000 and Oracle 10g. We have designed an in house software Elecpron 1.1 for Clinical Data Management. The software enables customising the project to follow certain compliances pertaining to computer systems for practicing clinical research.

How have you planned the application integration?

We have a SAS 1.1 tool for statistical analysis and it also acts as an integration platform. The data from both the laboratory information and Elecpron software is exported to SAS for integration. When there is a need to raise a query for a lab through Data Management System, it can be done through Elecpron.

How does the information flow and what is the role of IT in the pre-clinical and clinical research stages?

Drug development is done in the pre-clinical stage. The clinical stage includes phase I, II, III and IV of clinical trials of new drugs where experiments are done on a sample population.

The process is as follows- the investigators of the clinical operations team will collect the data from hospitals. The team then posts the data to the data management. The collected data goes through a data validation plan.

Subsequently, there is an audit process to ensure the correctness of contents of the change in data about the person who changed it, the time, date and reason for change. Finally, after all the queries are resolved, the data is logged and the results are out.

What will be your future deployments?

We will soon migrate the Elecpron software to .NET technology to make it web based. There are plans to include Electronic and Remote Data Capturing features that will enable the investigators to post the data directly from the hospitals by using a software to avoid duplication. This will also discipline the validation of data.