Contract research is a sunrise sector in the country and the domestic industry is expected to touch Rs 480 crore with a growth rate of 80% in the next few years. Domestic CROs have to move up the value chain from e-recruitment to e-submissions as majority of the data is critical and submitted for approval, says J Rajagopal, executive vice-president, global life sciences and healthcare, TCS. This requires specialised skills for both IT vendors as well as the members of a CRO team for automating their reporting system, dossier management, besides time-to recruit and time-to-submit period, he says.
The report is based on data collected from 17 companies 13 domestic companies and four MNCs. It says that the average IT spend was close to Rs 1.3 crore in the year 2003-04. The combined employee strength was 1,847 with clinical operations accounting for close to 46% and the staff of IT department was 0.02%. While the CRO industry is growing rapidly, it is an important aspect for IT-enabled management vendors to join hands with CROs for speedy trial management, Mr Rajagopal says.
CROs are now open to investment in technology and making improvements in their own processes. As per estimates by the Tuft Center for the Study of Drug Development, the cost of developing a new product has gone up from $131 million to $802 million. Indian CROs offer a range of services comprising phase I to phase IV studies. They offer cost savings of 50% for phase I and III clinical studies. These savings can be further increased if the e-infrastructure and technology are in place. However, limited pool of trained manpower is a major constraint. The report says that the USFDA will soon conduct an audit of Indian clinical trials due to heightened interest in outsourcing of clinical trials to India.
The average IT infrastructure across the surveyed companies differed substantially. It was found that for solution deployment and maintenance, majority preferred to take inputs from IT vendors while retaining the final decision making in-house. Consolidated spending on IT was in the vicinity of 0.75% of total revenue in 2003-04.
Once CROs become tech-savvy, e-clinical technologies will soon aid development, planning and initiation.