Submission of clinical trials with regulators is getting complex, and the ₹730-crore Chennai-based TAKE Solutions sees an opportunity for growth as global bio-pharma companies outsource these operations.

During the trial, a company needs to deal with tonnes of gigabytes of data that flow into the system from various sources, and places.

It needs to be collated and put in an electronics form, analysed and the results submitted to regulators in respective geographies, said Ram Yeleswarapu, President & CEO, TAKE Solutions, which has specialised in trials and submissions.

More number of clinical trials are being conducted across large number disease groups and more number people than ever participate in sample even as companies are launching drugs in many countries.

The kind of data sources feeding in to these trials have grown.

Earlier, trials were limited to Caucasian or an Asian population and companies used to push their trials with regulators on various parameters pertaining to that particular region.

Based on trial test of one region, companies could launch the drug in another.

Starting from a lab test to animal test to human trials and finally to submission could take 8-10 years and done in three or four phases with participation by thousands of people in various stages, he said.

TAKE acts as company’s development extension and their R&D team outside with over 1,200 Life Science professionals, he said.

TAKE’s platform uses predictive analytics, data analysis and machine learning algorithm.

It is cloud-based, and clients subscribe for the entire duration and they pay us on per patient per month.

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