Last updated : July 15, 2026 7:22 am
India's clinical research industry is evolving beyond project-based trials to deliver continuous evidence across a molecule's entire lifecycle
In an exclusive interview with Rahul Koul, Editor, Indian Pharma Post, Karan Daftary, Managing Director, SIRO Clintech discussed the evolution of India's clinical research ecosystem, the shift toward lifecycle evidence partnerships, AI-driven innovation, regulatory reforms, and why India is poised to become a global leader in evidence generation.
What inspired you to establish SIRO Clintech , and what gap in the clinical research ecosystem were you aiming to address?
When our Chairman, Dr Gautam Daftary established Siro Clintech, the question facing Indian pharmaceutical research was an elementary one. Could India do clinical research to match the standards of the global industry? At that point, Indian pharma was largely a generics-manufacturing story. The intellectual infrastructure for drug development, regulatory science, biometrics, and post-approval evidence existed in isolated pockets. The country had the medical talent, the patient populations, and the scientific tradition. What it lacked was the operational and quality scaffolding to translate that into research.
The original idea was straightforward. Build an Indian organisation that could run clinical research with the rigour, governance, and documentation discipline that international standards required, and that Indian sponsors and global sponsors operating in India could rely on with confidence. SIRO Clintech today is structured around a different approach - not whether India can do research, but whether the evidence generated through that research is being put to full use across the life of a molecule. That is what Lifecycle Evidence Partner means. The original gap was about capability. The current gap is about continuity, and the capability to maximize the long-term value of an asset beyond the completion of the clinical trial.
Can you take us through the company's journey so far including key milestones achieved?
The journey has had three distinct phases, and each phase was a response to a different question being asked of Indian clinical research. The first phase was establishment. Building the scientific, operational, and quality systems infrastructure to run trials that global sponsors and Indian regulators would treat as credible.
The second phase was expansion across the evidence chain. Medical writing, biometrics, regulatory affairs, pharmacovigilance, real-world evidence, and publication services were added not as separate business lines but as deliberately connected capabilities.
The third phase is where we are today: our evolution into a Lifecycle Evidence Partner. At its core is a four-pillar model encompassing Development Clinical Trials, Post-Approval Clinical Programs, Real-World Evidence, and Evidence Platforms & Intelligence, delivered through SIROai.
A milestone that underscores this transformation was SIRO Clintech's inclusion among the first cohort of Clinical Research Organisations to be registered under the New Drugs and Clinical Trials (Amendment) Rules, 2024. Registration was granted on 9 April 2025, just days after the new framework came into effect, reflecting the strength of our existing quality systems and operational discipline .
What are your latest initiatives and goals for FY27?
Our FY26–27 priorities align directly with this architecture. We are strengthening our Phase III capabilities in therapies, where Indian sponsors are advancing pivotal programmes at an accelerating pace. We are also expanding our post-approval clinical programmes, including a structured offering that mines historical Clinical Study Reports to uncover publication-ready evidence sponsors often don't realise they already possess.
At the same time, we are growing our real-world evidence capabilities with Indian prescribers and patient populations, where evidence gaps remain significant, while scaling SIROai-our technology platform built on more than five years of foundational R&D.
The broader technology organisation behind SIROai also operates an ISO 13485-certified diagnostics AI business, reflecting the engineering rigour and governance underpinning our platform. That sustained investment in technology is uncommon among Indian CROs and is increasingly becoming a key differentiator for sponsors.
How has India’s clinical research landscape evolved over the last two decades? How do you view the evolution from project-based clinical trials to lifecycle evidence partnerships?
The shift from project-based contracting to lifecycle evidence partnerships is the most consequential change in how sponsors and CROs engage. The project-based model treated a clinical trial as a closed transaction. A study was designed, executed, locked, and the relationship effectively ended. What sponsors then discovered, often years later, was that the same dataset could have answered questions a guideline body, a payor, or a prescriber community was now asking. The data existed. The architecture to keep working it did not.
A lifecycle evidence partnership inverts that logic. Evidence is treated as a continuum that begins before Phase III and continues through post-approval surveillance, real-world evidence, publication strategy, and prescriber communication. The CRO sits across the molecule’s life, not on a single project within it. This is a different commercial model, a different capability set, and a different governance discipline. It is also where Indian sponsors with global ambitions are now headed. The CROs that can support that arc with credibility will define the next decade of the industry here.
How can India move beyond being primarily a trial execution hub to becoming a centre for clinical innovation and research leadership? What opportunities do you see for India in emerging areas such as cell and gene therapies, precision medicine, and rare diseases?
The shift from execution hub to innovation centre requires three things, and India has been making progress on each. The first is moving from contract execution to scientific co-development. The CROs and academic institutions doing this work are still relatively few, but the direction is clear. The second is generating evidence that is uniquely Indian. Indian patient populations, comorbidity profiles, treatment pathways, and adherence realities are distinct from Western cohorts, and the evidence that comes out of Indian clinical research is therefore not redundant. The third is investment in the deeper scientific infrastructure that the next generation of therapeutics requires. Cell and gene therapies, precision medicine, and rare diseases each demand capability that goes beyond conventional trial execution.
What regulatory reforms have had the most significant impact on restoring confidence in clinical research in India? How are CROs adapting to evolving compliance expectations?
Under the New Drugs and Clinical Trials (Amendment) Rules, 2024, effective 1 April 2025, all CROs must be registered with the Central Licensing Authority before conducting clinical trials or bioavailability/bioequivalence studies. The framework requires robust infrastructure, qualified personnel, documented quality systems, and readiness for CDSCO inspections, with non-compliance carrying serious regulatory consequences.This marks the most significant structural reform for the CRO sector in decades.
SIRO Clintech was among the first cohort of CROs to receive registration under the new framework, with approval granted on 9 April 2025, just days after the rules came into effect. That early registration reflected the strength of our existing quality systems and operational discipline.
Beyond CRO registration, India's regulatory landscape continues to evolve. CDSCO has introduced structured Subject Expert Committee guidance, operationalised the country-of-approval waiver framework under Rule 101, updated draft Indian Good Clinical Practice guidelines to include electronic informed consent, decentralised trials, computerized systems validation, and risk-based quality management, and proposed revised biosimilar guidelines aligned more closely with global regulatory standards.
How are technologies such as artificial intelligence, machine learning, and advanced analytics transforming clinical trial operations today?
The honest answer is that the conversation around AI is still ahead of the operational reality. But that reality is changing quickly, with AI, machine learning, and advanced analytics beginning to transform how clinical trials are designed, managed, and analysed.
Site selection and feasibility, drawing on historical performance data rather than relationship-led guesswork. Protocol optimisation, surfacing eligibility criteria that historically caused recruitment failure before the protocol is locked. Adverse event signal detection across larger and more heterogeneous datasets than human review can sustain. Medical coding and adjudication support. Document review, including the extraction of structured data from clinical study reports, regulatory submissions, and the published literature. Centralised image and pathology reading, where machine-assisted reads accelerate workflow and improve consistency. Patient voice analytics from public sources, which surfaces signal that traditional market research methods miss entirely.
Where the gap between rhetoric and reality remains widest is in trial-level decision-making. AI does not yet design Phase III studies. It does not yet interpret regulatory strategy. It does not yet replace the judgment that goes into endpoint selection or comparator choice. The credible operating model is augmentation, not replacement. Technology compounds what experienced trial scientists, biometricians, and medical affairs leaders can do. It does not yet substitute for them.
At SIRO Clintech, our technology investment through SIROai is built on this premise. The platforms are designed around defined workflows, governed by quality systems, and operated by people whose judgment the technology supports.
Decentralized and hybrid clinical trials gained momentum during the pandemic. How sustainable is this model going forward?
The draft revision to India’s Good Clinical Practice guidelines, issued by CDSCO in September 2024, explicitly incorporates decentralised clinical trial methodology, electronic informed consent, and the validation framework for computerised systems used in trial conduct. Once finalised, this brings Indian regulation into alignment with the United States FDA’s 2024 DCT guidance and the EMA’s DCT framework, and removes much of the regulatory ambiguity that previously made sponsors cautious about hybrid designs in India.
For India specifically, the picture has additional texture. Digital infrastructure has improved significantly but is not uniform. Patient comfort with telemedicine has grown, but supervised data collection remains the more reliable design choice in much of the country. The pragmatic Indian DCT or hybrid model is therefore selective: home-based PRO collection, telemedicine for routine follow-up, courier-based sample logistics in defined contexts, with site-based assessment retained for the methodologically demanding components of the protocol. That model is sustainable. The fully decentralised trial, in the Indian context, remains more aspiration than operating reality for most therapeutic areas.
What emerging trends will shape the future of clinical research over the next five to ten years? Will the CRO business model undergo significant transformation in the coming decade?
Several trends are converging, and together they will fundamentally reshape the CRO business model. First, sponsors are moving from project-based contracting to long-term evidence partnerships, consolidating clinical trials, post-approval programmes, real-world evidence, and publication strategy with a single partner. This favours CROs with end-to-end capabilities over single-service providers.
Second, the focus is shifting from the cost of generating data to the value that can be created from it. A well-designed Phase III trial can generate multiple publications, post-approval studies, and real-world evidence that influences clinical practice for years.
Third, technology and AI are becoming the operating foundation of modern CROs rather than standalone tools. Organizations that have invested in proprietary platforms, supported by robust quality systems, will have a clear advantage over those relying on off-the-shelf solutions.
Fourth, patient voice and investigator insights are emerging as valuable evidence streams alongside traditional clinical data. Sponsors increasingly expect these insights to inform development programmes, requiring CROs to build the methodological and technological capabilities to generate them at scale.
Fifth , India is seeing a structural consolidation of its CRO industry. Mandatory CRO registration, introduced in April 2025, has established regulatory compliance and audit readiness as the minimum standard. As a result, competition is shifting away from cost arbitrage towards capability, quality systems, and the ability to support a molecule across its entire evidence lifecycle-not just through regulatory approval.
As someone who has witnessed the evolution of India’s clinical research sector firsthand, what is your vision for the industry over the next decade, and what role should India play in advancing global healthcare innovation?
I had the privilege of building on the foundation laid by our Chariman, Dr. Gautam Daftary, who is also credited with establishing the India’s clinical research industry. My vision is built around a simple distinction- The first chapter of India's clinical research journey was proving that we could conduct trials to global standards. That question has been answered. The next chapter is about generating evidence for Indian patients in Indian clinical settings. India has patient populations at a scale and with disease profiles that are unlike anywhere else-from prediabetes and metabolic disorders to liver disease, hepatitis, oncology, and complex multi-drug treatment patterns. Yet clinicians often rely on evidence generated in very different populations and healthcare systems.
The opportunity now is to generate evidence that reflects how Indian patients are treated in real-world practice. When that evidence goes on to shape global guidelines, it will be because it is scientifically robust and clinically relevant .That's why I believe the future is about evidence for India, not just evidence from India.