How would you describe the current and evolving clinical research landscape in India, and what key shifts are shaping its future?
India’s clinical research ecosystem has positively evolved over recent years. What was once viewed earlier as a low-cost destination for clinical research is now rapidly becoming a more science, quality, innovation and value driven R&D ecosystem. Recent initiatives like Biopharma SHAKTI signal a clear national commitment to high-end drug development and deeper scientific innovation, rather than just focusing on scale and volume.
A few key changes are really driving the process. NDCT2019 rules have helped the regulatory systems becoming more predictable than before which gives global sponsors greater confidence in working with India than preCOVID. Technology is no longer an add-on but a part of how trials are designed, with data-led tools and hybrid models helping improve efficiency, patient access and operational quality. At the same time, stronger infrastructure through experienced sites and specialised institutions, investigator capability and expertise is making a real difference on the ground. Together, these developments are helping India evolve into a trusted, innovation-centric and globally integrated clinical research destination.
How is digital innovation – particularly decentralised and virtual clinical trial models—transforming trial design, execution, and patient participation in India?
Digital innovation has fundamentally changed how clinical trials are designed and conducted in India. Instead of being limited to large urban hospitals, trials are increasingly using hybrid models where critical procedures happen at accredited centres, while routine follow-ups and monitoring can take place closer to a patient’s home. Tools like electronic consent, mobile-based endpoint reporting, and digital health platforms such as ABHA are making participation and data gathering easier and real time. By reducing the need for frequent travel and using technology to stay connected, decentralised approaches are helping trials become more inclusive, practical, and patient friendly, while still maintaining strong medical oversight and safety standards.
What recent policy and regulatory developments are most significant for clinical research, and how is India progressing towards global regulatory harmonisation?
Recent policy changes have made a noticeable difference in how clinical research operates in India. The updated NDCT Amendment Rules have simplified processes for certain low-risk studies and reduced approval timelines for others, making the system more predictable and efficient. This shift shows greater trust in sponsors while still maintaining regulatory oversight. At the same time, India is steadily aligning with global standards by strengthening data protection norms, formalising CRO registration, and harmonising pharmacopoeia standards.
Initiatives like Biopharma SHAKTI have energised the Clinical research fraternity in the country by the emphasis on 1000+ clinical trial sites in the country and additional strengthening of the scientific review within the regulatory system in India which also reflect a clear intent to support advanced therapies and innovation. Overall, these developments show that India is serious about building a globally aligned, credible, and futureready clinical research ecosystem.
Across core domains such as clinical operations, data management, medical writing, biostatistics, pharmacovigilance, and real-world evidence, where has India made the greatest progress and where are the key gaps?
In 2026, India serves as the reliable “technical engine” for global research, where our mastery in Data Management has evolved from simple outsourcing into a sophisticated, hub operations powerhouse. While we are world-class at managing the heavy lifting of data and regulatory writing, a human gap is still present in our specialised fields where we still lack clinical development professionals at scale who can develop indigenous protocols from India for global drug development keeping the scientific tenor at pace.
We are incredibly efficient at processing safety reports in pharmacovigilance, yet we still need more veteran medical experts who can spot safety signals before they become problems and also efficiently work with the global data sets and triage them in India. Similarly, despite our massive digital health push, our Real-World Evidence is still finding its feet due to fragmented hospital records, and our capacity for Phase I trials remains limited to a few elite centers rather than being a nationwide reality.
Our skilled manpower at sites is a strength where partnership with BIRAC, ICMR and all agencies working on the mission of 1000+ sites in India will be the opportunity for the upcoming years.
How are patient-centric and ethics-led research approaches being strengthened in Indian clinical trials today?
Truly patient-centric and ethics-led research at the site level in India means moving beyond compliance to genuine partnership with participants. Patients and their care givers are treated as informed partners, with consent explained in simple, local languages and supported by assisted digital tools where needed. Patient’s are also ensured of flexible visit schedules, and remote monitoring where appropriate. The involvement of caregivers cannot be underscored as they are an important pillar of patient centricity.
We also need involvement of the patient advocates to work to have patient voice incorporated in our protocols so that the designs are such that they promote practical usage close to clinical practice as much as possible depending on the disease under study. The ethics committees are also partners in making this as simple for the patient as possible. Ultimately, ethical research today is about trust, transparency, and making participation practical and respectful for every patient and their caregivers.
What opportunities and challenges do you see in academia–industry collaboration, particularly in building a future-ready clinical research workforce?
Academia–industry collaboration offers a valuable opportunity to move from theoretical knowledge to practical, impact-driven innovation. India has strong academic talent, and when this is combined with industry’s funding, infrastructure, and real-world exposure, it can help build a workforce that is prepared for emerging areas such as biologics, advanced analytics, and digital clinical trials. This is particularly important as clinical research becomes increasingly data-driven and technology-enabled. At the same time, there is a gap that needs attention. Academic institutions often operate on longer research timelines, while industry works with speed and commercial urgency. Bridging this difference will require deeper and more structured engagement through joint research programs, hands-on training, shared facilities, and real-world problem solving initiatives. This will ensure that students enter the workforce not only with strong academic foundations but also with the practical skills and adaptability needed in a rapidly evolving clinical research ecosystem.
As India aspires to be a global clinical research hub, what skills, career pathways, and ecosystem enablers will be most critical in the coming years?
As India works toward becoming a global clinical research hub, the skills required are clearly changing. Professionals will need to combine strong medical knowledge with digital capabilities such as data analytics, AI tools, decentralised trial platforms, and a solid understanding of data privacy and regulations. The focus is shifting from routine execution to problem solving and evidence generation. We are also seeing new roles emerge, including clinical data specialists, decentralised trial planners, and real-world evidence analysts. At the same time, stronger site networks, support for biologics research, better industry and academia collaboration, and faster, globally aligned regulatory systems will be key enablers.
The future belongs to professionals who are adaptable, digitally fluent, and patient-focused.
On the occasion of Women’s Day, what message would you like to share with women aspiring to build and lead impactful careers in clinical research?
Women have always played a vital role in shaping life, communities, and progress — and their contribution to science and healthcare is equally powerful. Clinical research is a field that requires empathy, integrity, attention to detail, and strong leadership. Many women bring these strengths naturally and their growing presence in this space continues to enrich the industry in meaningful ways. To those aspiring to build meaningful careers in clinical research, my message is simple: believe in your abilities, keep learning and step forward with confidence. Don’t hesitate to take on leadership opportunities or make your voice heard.
Our industry thrives on diverse perspectives and inclusive thinking, that is how we design research that is ethical, equitable, and truly patient-centered. Your contribution can shape not just studies, but lives. Stay confident, stay curious, and never underestimate the difference you can make. It is often observed that when men exhibit visionary and strategic leadership, credit is attributed to their personal capabilities. However, when women demonstrate similar leadership qualities, it may be perceived as dominance, with recognition frequently extended to the team instead. Regardless of how credit is assigned, it should not be regarded as the sole measure of success.
Instead, focus on discovering your purpose and lead authentically according to your individual leadership style.
swati.rana@expressindia.com
swatirana.express@gmail.com