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In the last one decade, the Indian IT industry has seen a nearly 360-degree shift in the outsourcing of Clinical Data Management (CDM) activities. This shift started happening sometime in early 2004, and over the last decade, we’ve been making steady advances in knowledge harvesting, scaling up capability, cost balancing, and technological transformation and flexibility. Outsourcing has now evolved as the one-word solution to overcome every hurdle in meeting the above mentioned prime parameters.
It is an emerging phenomenon in the pharma / biotech information technology market which promises to result in significant cost savings and improved process efficiencies.
Interestingly, India is the most preferred location for outsourcing CDM activities and this is so because of several reasons. Every year, 2 million graduates join the workforce pool (the existing pool houses over 25 million people). Additionally, the country witnesses over 1,00,000 fluent English-speaking graduates and 1,20,000 engineers becoming a part of its resource stable every year.
In the healthcare industry where CDM is being outsourced, not only is company profit important but benefits too are of equal concern. Outsourcing CDM activities in India reduces operating costs and provides higher levels of service for the same or lower costs. The sponsor gets to focus on the core business and let the operational details be managed by an external expert in India. Moreover, outsourcing in India leads to gaining access to world-class capabilities, increased efficiency, reduced overhead costs, and optimal resourcing, scaling and utilization of common applications.
The ‘end-to-end’ concept is nowadays a rage in the Indian IT industry with respect to sponsors’ healthcare services. For instance, these services include protocol review and input for better integrated service, case report form designing, data management plan creation, all set up-related activities, clinical programming including database building and validations, software / database testing, statistical analysis, conducting and managing the study data till the database lock stage, cleaning and submission of database, and so on. The technical activity for any clinical study starts with database building and programming, followed by statistical analysis before submission to the FDA. A well-built and flawlessly running study provides more promising results out of the set protocol. In India, IT organizations that provide services to healthcare industries overseas have ample resources trained in different clinical databases. This helps them to provide flexible options to investors. Due to a rise in costs for existing clinical databases and services, the evolution of new databases and cloud computing are more reliable and preferred choices.
One of the most problematic areas for the pharma industry is the analysis of clinical data after several years of research have gone into deriving the results. Given that the volume of such data is huge, it becomes even more important to ensure a fast, yet accurate, analysis process. The existing reporting tools from IT firms based out of India are costly and require continuous communication to overcome server slowness. No surprise then that Indian IT firms are coming up with reporting tools that are way cheaper and are customizable as per sponsors’ needs. There are several such tools that can be used to prepare these custom reports. For instance, JReview, BOXI, SAS, and so on. Apart from these, in-house reporting software can also be made on other programming languages. Also, analysis of these reports is easier, thanks to the use of matrices which provide a much clearer picture of the data. Big Data analysis is also one of the most prominent things that has come into the picture in recent years for the pharma industry, primarily because of its promise of being able to provide robust and accurate business and drug development projections, apart from giving a far clearer picture of the data than ever before.
The combination of domain knowledge and technological know-how in IT companies is luring an increasing number of pharma and biotech organizations towards leveraging the end-to-end capabilities of these companies. On offer is getting the best of both worlds – domain excellence and technological enhancement. Right now, we are at a summit where we will see both IT and CRO racing against time to come out victorious.