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Data driven approach in clinical trials to aid identifying risks critical to patient safety: Ram Mudaliar

Nandita Vijay, Bengaluru
Monday, February 7, 2022, 08:00 Hrs  [IST]

Data driven approach in clinical trials will aid in identifying risks critical to patient safety. There is a need to shift towards innovative solutions to ingest huge volumes of data with faster and more accurate decision-making mechanisms, stated Ram Mudaliar, senior director, India-lead, clinical data & insights, AstraZeneca.

Clinical trials have more of a data driven approach with a lean mindset wherein the expectation is to derive data insights, identify risks well in advance, so that we can course correct it accordingly, he added.

With current advancements towards rapid data processing, there is an awareness of data handling and privacy regulations. There is no difference in clinical trials conducted globally or in India. Our country is seen to be part of the global studies when choosing where to perform a trial. For the operational execution of that trial, pharma companies are investing in talent that has grown in the Indian market and most major pharmas and clinical research organisations (CROs) have varying degrees of presence in India now, Mudaliar told Pharmabiz.
Visible trends indicate a shift from conventional data collection tools such as case report forms, to data being captured via various devices, a greater focus on easing the patient burden by enabling the patient to complete some of the aspects of the clinical trial at home thus reducing the number of visits to the clinic. There is an increased attention to reducing the number of blood draws and use of technology to automate the activities that happen once the data has been collected. The skillsets to manage these tasks are very mature now and initial obstacles no longer exist, he said.
AstraZeneca’s clinical data & insights division has a global footprint in over 7 countries with over 400 employees and an additional 900 among its CRO partners. The global pharma major has envisaged that this is the best time to enter the Indian market considering the experience and talent available here. Since the company already had a presence in Bengaluru, it was a natural choice to base its CDI team here enabling career development pathways for the company in the long term.
“We entered in the India market mid last year and we are growing steadily. Current team strength here is around 35 employees. Plans are to continue expand the team size this year. We are here to collaborate and learn from other pharmaceutical companies and partners, connect with them to share knowledge at appropriate forums. Ultimately, we are all working towards bringing quality medicines to patients,” said Mudaliar.


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Adersh Nair Feb 9, 2022 10:50 PM
As industry is experiencing a paradigm shift to patients centricity, it's important to realise how will be data managers' correspondence with patients. As data gets transmitted to data managers directly from patients, DMs will have to establish communications with patients for queries related to the data that gets generated at homes.
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