As India emerges as a global leader in digital health innovation, its clinical trials landscape is evolving at an unprecedented pace. In this exclusive conversation, Santhosh A F, Vice President, Asia Pacific South & India at Medidata, shares with Dr. Asawari Savant from Elets News Network (ENN), how technology, AI, and patient-centric approaches are reshaping clinical research in India—unlocking new possibilities for faster, more inclusive, and data-driven drug development. Edited excerpts 

What are the major trends, challenges, and opportunities in the clinical trials industry in India? 

India’s clinical trials industry is undergoing rapid transformation. The growing adoption of technologies such as artificial intelligence (AI), wearables, and data analytics is improving efficiency, broadening patient access, and enabling more representative research. With its diverse and treatment-naïve population, there is strong potential for India to become a global clinical trial hub. 

However, challenges remain. India still has limited early-phase trial capacity, which constrains innovation at the outset of drug development, and there’s a need to address skill gaps and high talent attrition. Public awareness and trust in clinical research also need strengthening, particularly in tier-2 and tier-3 cities where participation remains low despite a large patient base. 

By expanding infrastructure, investing in talent, and fostering collaborations across sectors, India can address unmet medical needs and strengthen its position as a clinical trials hub.

India has a rapidly growing digital ecosystem, particularly in the mobile space. How can mobile-first approaches help overcome infrastructure challenges and enable more accessible and inclusive clinical trials across the country?

India’s rapidly growing digital ecosystem creates unique opportunities to make clinical trials more inclusive. Mobile-first approaches help bridge infrastructure gaps by allowing patients to engage with trials from their own devices, wherever they are. Tools like electronic clinical outcome assessment (eCOA) enable real-time data collection at home, while eConsent ensures patients receive comprehensive trial information without visiting a clinic. The rise of Bring Your Own Device (BYOD) has shifted trials away from rigid, provisioned devices toward more patient-friendly models. This flexibility is especially critical in areas like the central nervous system (CNS) and rare diseases, where decentralised, mobile-enabled designs can improve participation and ensure high-quality data capture.

Patient engagement and experience are crucial for successful clinical trials. What role can technology play in enhancing patient engagement?

Technology is transforming patient engagement by reducing burden and creating more meaningful trial experiences. Tools such as eConsent, eCOA, and wearable devices are not only decentralising trials but also helping patients stay informed and connected. Patients want to understand the research they commit to, and technology can simplify complex processes, from onboarding to study completion, by streamlining tasks into a single, intuitive platform. This makes participation less disruptive to daily life, increases retention, and ultimately strengthens the quality of data. 

What is the role of AI in decentralised clinical trials (DCTs)?

In DCTs, AI strengthens oversight by processing real-time information from wearables and digital health tools, making it possible to monitor participants remotely and even create synthetic control arms that reduce reliance on placebo groups.

The potential impact of AI in trials is significant. Morgan Stanley estimates that AI could help bring 50 new treatments to market within a decade, cutting drug discovery timelines from years to months and reducing development costs. At Medidata, our “AI Everywhere” strategy is delivering this vision in practice. By embedding intelligence across the trial lifecycle, we have achieved tangible results such as reducing study startup times by up to 75% and study build times by 80%.

AI is also reshaping how we understand treatment efficacy in complex areas like oncology. In a study with AbbVie, we used AI to analyse real-world data and establish critical benchmarks for future therapies. These insights also uncovered patient subgroups with better outcomes, helping accelerate the development of next-generation treatments.

How important is it to localise technology solutions and to involve patients in the development and design process of clinical trials?

Localising technology and involving patients early are essential to improving the likelihood of a successful clinical trial. A localised, decentralised model creates opportunities to include underrepresented groups who may not be able to travel to trial sites. But true patient centricity goes beyond decentralisation; it means designing studies around patients from the outset – asking how trials can fit into their life rather than asking patients to fit into a trial.

When patients are involved in shaping protocols, trials become more relevant and trusted. Patient involvement benefits sponsors too. Trials become more efficient, with fewer protocol amendments and smoother recruitment and retention. Evidence shows that drugs developed through patient-centric design are 19% more likely to gain regulatory approval. 

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As India embraces more patient-centric and technology-enabled clinical trials, what regulatory or ethical challenges do you anticipate, and how can these be addressed while maintaining global standards and patient safety?

As clinical trials in India become more patient-centric and technology-enabled, the main challenge will be aligning innovation with regulatory and ethical safeguards. Adaptive designs and real-time insights must be validated within frameworks that preserve scientific integrity, which will require stronger alignment between sponsors and regulators. 

The government is already moving in this direction. With its push for innovation and indigenous manufacturing, the Union Health Ministry has proposed amendments to the New Drugs and Clinical Trial Rules. The draft rules aim to cut regulatory delays, halve approval timelines, and attract both global pharma companies and domestic innovators. 

While this can fast-track access to new therapies, patient consent and data privacy still demand careful oversight to build trust. The way forward lies in creating intuitive, accessible systems that support patients throughout their journey, while ensuring global standards are upheld. Modernising trials in India is not just about technology; it is about making trials safer, more inclusive, and more efficient for all.

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Disclaimer: The views and opinions expressed in this article are solely those of the author and do not necessarily reflect the official policy or views of any organisation. The content is intended for informational and educational purposes only and should not be construed as medical advice.

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