“AI is reshaping clinical trial design and execution, especially in India”

In an exclusive interaction, Dr Saurabh Arora, Managing Director, Auriga Research shares insights on the growing influence of AI in the clinical trials ecosystem; company’s latest partnerships, current activities and future outlook.
What is the strategic significance of this MoU between Auriga Research and the San Francisco Research Institute? How will it enhance Auriga’s capabilities in translational research, AI based clinical trial support, or regulatory science?
This MoU marks a significant step forward for both Auriga Research and SFRI. From a strategic standpoint, it enables both organisations to expand their geographical footprint in complementary markets. While SFRI has a strong presence across North America, Europe, Africa, and parts of Southeast and Far East Asia, they were looking for a capable partner to enter and scale in India. At the same time, we were seeking access to global markets, making this a natural and mutually beneficial collaboration.
Beyond geography, the partnership is built on strong complementarities. SFRI’s deep capabilities in clinical research and regulatory science align well with our strengths in analytical testing, biosafety, and in vitro services. Together, we aim to offer end to end translational research capabilities from product development and clinical studies to global regulatory enablement.
The partnership also enhances our potential in AI based clinical trial support. We are now evaluating unified AI enabled software solutions to streamline clinical operations across geographies. This includes automating documentation, improving patient data analytics, and enabling faster, more compliant trial execution.

How is AI currently transforming clinical trial recruitment, especially in terms of patient identification and diversity inclusion?
AI is beginning to play a transformative role in how trials are designed and executed, especially in India. One of the key areas of innovation is patient recruitment. With our access to large and diverse patient populations in India and SFRI’s global network, we are now actively exploring AI solutions that can screen electronic health records and demographic data to identify the most suitable trial participants quickly and accurately.
This not only accelerates recruitment timelines but also enables better inclusion across ethnicity, gender, age, and comorbidities, leading to more robust real world evidence for sponsors targeting global markets.
“As part of our collaboration with SFRI, we are currently developing a unified digital infrastructure that supports adaptive trial designs and real time data monitoring.”

What advancements has Auriga made in AI powered data monitoring and adaptive trial designs?
As part of our collaboration with SFRI, we are currently developing a unified digital infrastructure that supports adaptive trial designs and real time data monitoring. The goal is to use AI and ML to dynamically adjust protocols based on interim results, improve endpoint detection, and optimise resource allocation during the trial lifecycle.
While this remains a medium to long term roadmap, we are excited about the possibilities it opens up, particularly in improving trial efficiency and decision making accuracy while remaining aligned with global GCP and regulatory standards.

Are you integrating AI or ML to detect adverse events or ensure real time pharmacovigilance? If so, how effective has that been?
Yes, we are currently evaluating AI and ML based systems that can monitor clinical trial data in real time to detect potential adverse events more accurately and proactively. This involves using algorithms trained on historical datasets to flag anomalies, cross reference them with drug profiles, and alert clinical teams for timely action.
Although still in pilot phases, the early indicators are promising in terms of reducing reporting delays and enhancing patient safety. Our collaboration with SFRI is helping accelerate the development and validation of these systems across markets.

How do you see India emerging as a global hub for digital health, evidence based wellness, and research outsourcing?
India is rapidly evolving into a global hub for digital health and evidence based wellness research. Across sectors like nutraceuticals, ayurveda, and personal care, there is a growing demand for products backed by scientific validation and clinical proof. Consumers today expect not just safe products but also demonstrable efficacy, bringing the bar closer to pharmaceutical grade standards.
With our large, diverse population and deep talent pool, India offers a unique advantage in clinical research, particularly in terms of rapid and diverse patient recruitment. Combined with cost effectiveness and a mature regulatory environment, research outsourcing into India is set to grow at an impressive pace.
“We offer a comprehensive suite of services ranging from microbiological, chemical, and safety testing to clinical trials for efficacy and claims validation.”

What role is Auriga playing in positioning India as a leader in regulatory research, quality assurance, and biosafety testing?
Auriga has long positioned itself as a one stop partner for innovation, quality assurance, and regulatory readiness. We offer a comprehensive suite of services ranging from microbiological, chemical, and safety testing to clinical trials for efficacy and claims validation.
With decades of industry experience, our testing protocols align with the highest global standards, and we have been instrumental in helping Indian and global clients meet regulatory requirements across markets. With the SFRI collaboration, our global outreach strengthens further, enabling us to guide clients from development through to global market access under a unified quality and regulatory framework.

What is your vision for expanding Auriga’s footprint into Africa and North America?
Our vision is clear: to extend Auriga’s trusted quality and research services to new geographies while maintaining the same excellence we have demonstrated in India. With multiple USFDA compliant sites, WHO prequalification, and consistent global audit success, we have already proven our ability to deliver internationally.
Through this partnership with SFRI, we aim to not only serve more customers across Africa and North America but also eventually set up local facilities in these regions. Our goal is to offer faster, on ground support to clients in these markets while continuing to channel business and innovation opportunities into India.
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