Interview

'Software implementation requires validation'

Asian Clinical Trials (ACT) is the clinical research operations division of Suven Life Sciences. Venkatraman Sunder, the Vice-President, Operations talks to Nandini Patwardhan about their IT implementation.

What are the IT needs of a CRO?

Data management, clinical trial management system, document management system, statistical analysis tool, data back up and disaster solutions, anti-spam and firewall solutions, high bandwidth network are the basic needs of any CRO. Further, IT based solutions are very much required for maintaining database of investigators, trial material inventory management. It also enables collection of data from subjects through various electronic gadgets such as patient diaries and programmed electronic devices. There is no end to requirement of IT in a CRO. It takes shape as the organisation grows. In the CRO industry, compliance to regulatory requirements such as CFR Part 11 and validation of systems plays a major role.

The clinical trial management activities related to regulatory document collection, project management, workflow, reporting, site management are the key functions which are covered in Clinical Trial Management Systems (CTMS). Data management is a major process which can be automated and the data can be collected at a single source from the global sites, this shortens the time to market for a new drug. Backup and disaster recovery system can be automated for continuous operations.

How is the solution implemented in your organisation?

We have got Oracle Clinical ver4.5 implemented by Infosys in March 2004. ACT is the first in India to have Oracle Clinical implemented and validated. The entire process took around three months from March to May 2004. A team of five people from Infosys were dedicated and were stationed in Hyderabad for this purpose and they carried out the entire job very professionally and on time. This system was enabled by middle of May 04 and ACT completed the first data management project from European sponsor by closing the data by end of June 04, the fastest by any standards and well appreciated by sponsors.

Proper planning by Infosys and support from Oracle Corporation has enabled a smooth implementation. Apart from efficient internal IT support team, trained manpower within ACT, from medical, trial management and data management solutions enabled the process. It was a team approach and everyone enjoyed the implementation and overcame the challenges. In addition to Oracle Clinical, we have implemented CTMS, document management systems, statistical planning and analysis tools, backup and disaster management and firewall systems.

What are the areas that need to be taken care of during IT implementation?

Every software implementation in CRO requires adequate validation and documentation. IQ, OQ, PQ and compliance documentation are a part of documentation for software implementation. IQ is done during the process of installation of the software, without which the system cannot be used for the purpose. OQ is done when the entire installation is completed; the system is checked for its operational qualification of the defined requirements. PQ is done while using the system. Users should also be trained to understand the architecture of the IT solution implemented, the purpose of implementation, advantages to organisation, these will primarily set the focus of the users. All the users should be trained on the usage of the solution to carry out the operations effectively.

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