TheCconnects: Dr. VijayKumar Gawali, it’s an honor to sit down with you today. You’ve built an extraordinary career in clinical research, medical academics, and hospital administration. Could you share a glimpse of your professional journey and what led you to your current role at Bhaktivedanta Hospital?
Dr. Vijaykumar Gawali: Thank you for having me. My journey in healthcare and clinical research spans nearly two decades, rooted in a passion for improving patient outcomes through evidence-based medicine. I began my career as a young physician, deeply curious about how clinical trials could bridge the gap between innovative therapies and real-world patient care. After completing my medical education at Topiwala National Medical College, I dove into clinical trial operations, starting with roles at prestigious institutions like Jaslok Hospital and Research Institute Mumbai and Kokilaben Dhirubhai Ambani Hospital and Research Institute , Mumbai.
Over the years, I’ve worn many hats, clinical research coordinator , co-investigator, medical superintendent, ethics committee member secretary ,academic leader, and NABH assessor. Each role taught me the importance of integrating research, education, and patient care. My current position at Bhaktivedanta Hospital allows me to lead clinical research and academics while overseeing hospital operations. It’s a unique opportunity to drive innovation, mentor the next generation of researchers, and ensure high-quality patient care. The journey hasn’t been linear, it’s been a blend of persistence, learning from global experts in places like Singapore, Malaysia, Dubai (United Arab Emirates), Hong Kong, Austria, Switzerland, Thailand, and Italy and a commitment to pushing boundaries in India’s clinical research landscape.
TheCconnects: That’s an inspiring trajectory. Who would you say has been the most influential figure in shaping your approach to your work and life?
Dr. VijayKumar Gawali: That’s a great question. I’d point to two influences: Gaur Gopal Prabhu, a revered monk from Radha Gopinath Temple, mentored me and shared profound insights on living a meaningful life—gratitude for being alive and the importance of giving back to society in the best way I can.
my mentors Dr Mohit Bhatt and Dr Annu Aggarwal , who taught me that research isn’t just about data, it’s about people. His encouragement to question established practices and seek innovative solutions has stayed with me. Dr. Sankhe, the esteemed director of Bhaktivedanta Hospital and Research Institute, imparted a profound lesson that research transcends mere data collection; it is fundamentally rooted in a passionate attitude to innovate and develop treatment methods that serve the greater good of humanity. His insights inspired me to view research as a compassionate pursuit driven by a genuine desire to make a meaningful difference in people’s lives, emphasizing that true progress in healthcare arises from dedication, creativity, and a relentless commitment to the welfare of mankind.
Equally, the patients I’ve met through clinical trials have been profound teachers. Their courage in participating in trials, often in the face of serious illness, reminds me why we do this work. Their stories drive me to ensure that every trial we conduct is ethical, impactful, and patient-centered.
TheCconnects: Your career includes overseeing hundreds of clinical trials and leading accreditation efforts. What have been some of the biggest challenges you’ve faced, and how did you navigate them?
Dr. VijayKumar Gawali: The clinical research field is fraught with challenges, particularly in a diverse and complex country like India. One significant hurdle was establishing robust research departments in hospitals that traditionally prioritized clinical care over research. When I joined Kokilaben Dhirubhai Ambani Hospital and Research Institute, for instance, the research infrastructure was nascent. Building a department from scratch required aligning stakeholders, hospital leadership, clinicians, and ethics committees, while ensuring compliance with international standards like ICH-GCP.
Another challenge has been navigating regulatory complexities. India’s regulatory landscape for clinical trials has evolved significantly, but there were times when ambiguous guidelines created roadblocks. I overcame this by investing in continuous training, both for myself and my teams, through international workshops in places like Austria and Thailand. These experiences equipped me with the tools to streamline processes, from feasibility assessments to site monitoring, while maintaining ethical rigor.
Perhaps the most humbling challenge was during my tenure as an NABH assessor, auditing ethics committees across over 50 hospitals. Ensuring compliance while fostering a culture of ethical research required diplomacy and persistence. I leaned on open communication, mentorship, and fostering a shared vision of patient safety to drive change.
TheCconnects: Those are remarkable achievements. Reflecting on your career, what key lessons have you learned that continue to guide you?
Dr. VijayKumar Gawali: One lesson stands out: collaboration is the cornerstone of success in clinical research. No trial succeeds without a cohesive team, investigators, coordinators, regulators, and patients all play a role. Early in my career, I underestimated the power of interdisciplinary teamwork, but leading centers of excellence in oncology and cardiology taught me how to bring diverse expertise together for a common goal.
Another lesson is the importance of adaptability. The clinical research landscape is constantly evolving, new regulations, technologies, and therapeutic areas emerge regularly. Staying ahead requires a commitment to lifelong learning, whether through conferences, publications, or global training programs.
Finally, I’ve learned that integrity is non-negotiable. Whether it’s ensuring accurate data in a trial or maintaining transparency with patients, ethical conduct is the foundation of trust in research. This principle has guided my work in supervising over 500 investigator-initiated trials and mentoring young researchers.
TheCconnects: Speaking of the broader landscape, what do you see as the biggest challenges for organizations in the clinical research space, particularly in the digital era?
Dr. VijayKumar Gawali: The digital era has transformed clinical research, but it’s a double-edged sword. One major challenge is data integrity and security. With the rise of electronic data capture systems and remote monitoring, ensuring data privacy while complying with regulations like GDPR and India’s DPDP Act is critical. Organizations must invest in robust cybersecurity and train staff to handle sensitive data responsibly.
Another challenge is patient engagement in a digital world. While digital platforms make recruitment easier, they also risk depersonalizing the process. Patients need to feel valued, not like data points. Balancing technology with human connection is key, something we prioritize at our organization.
Lastly, there’s the challenge of keeping pace with innovation. Artificial intelligence and real-world evidence are reshaping clinical trials, but adopting these tools requires significant investment and expertise. Organizations that fail to adapt risk falling behind, while those that embrace innovation thoughtfully will lead the way.
TheCconnects: Your organization provides comprehensive services to the clinical trial industry. How do your solutions address the pain points of your clients and partners?
Dr. VijayKumar Gawali: At ClinverseEdge Organization and through our educational arm, we tackle several pain points head-on. One common issue is the lack of trained personnel in clinical research. Our training modules, led by seasoned investigators and regulatory experts, equip professionals with practical skills in trial design, ethics, and data management. We’ve trained over 500 professionals, many of whom now lead trials across India.
Another pain point is regulatory compliance. Navigating approvals from bodies like the DCGI or ethics committees can be daunting. Our consultancy services streamline this process by providing end-to-end support, from protocol development to site audits. For instance, our work in securing SIRO accreditation from the Ministry of Science and Technology has helped our clients access govt funding for research.
Finally, we address the gap in high-quality medical writing. Our team has authored over 100 publications and guided many medical writers in the industry. This holistic approach, education, regulatory support, and writing, ensures our clients can focus on advancing science while we handle the operational complexities.
TheCconnects: That’s a comprehensive approach! Shifting gears, what do you do to unwind or spend your free time?
Dr. VijayKumar Gawali: In my free time, I am committed to supporting the growth of our nation’s medical research by volunteering my time to assist clinical research professionals and their projects, entirely at no cost. I believe that nurturing and empowering these professionals is essential for developing world-class research talent within our country. By providing dedicated support to various medical research institutes, I aim to contribute to their success and help advance innovative healthcare solutions that can benefit society as a whole. I have the same passion for executing my responsibilities in my personal life
TheCconnects: It sounds like you bring the same passion to your personal life as you do to your work. What advice would you offer aspiring entrepreneurs or professionals in clinical research?
Dr. VijayKumar Gawali: First, build a strong foundation in ethics and regulations. Clinical research is a field where shortcuts can have serious consequences, so understanding GCP and local guidelines is non-negotiable. Second, invest in relationships. Network with mentors, attend conferences, and learn from global experts, these connections will open doors and provide invaluable insights.
Third, embrace technology but don’t let it overshadow the human element. Tools like AI can enhance efficiency, but patients and colleagues need empathy and trust. Finally, be resilient. Rejections, regulatory hurdles, and trial setbacks are part of the journey. Learn from them, adapt, and keep your focus on the bigger picture: improving lives through research.
TheCconnects: One last question, where do you see the future of clinical research in India heading in the next decade?
Dr. VijayKumar Gawali: India is poised to become a global hub for clinical research, given our diverse population and growing expertise. I see decentralized trials and real-world evidence playing a bigger role, especially with advancements in telemedicine and wearable devices. There’s also immense potential in personalized medicine, particularly in oncology and rare diseases, where India can contribute significantly to global research.
However, we need to address gaps in infrastructure and public perception. Building trust in clinical trials through transparent communication and community engagement will be crucial.
I am optimistic about our nation’s future in clinical research. India, with its vast talent pool and rich scientific heritage, holds the power to lead the world in clinical innovation. But for that, we must first invest in our youth — by educating, empowering, and inspiring them to become world-class clinical research professionals. This is not just about building a career path; it’s about building India’s global identity in ethical, patient-centric, and pioneering research. Let us unite — educators, institutions, policymakers — to ignite this movement, so that the world doesn’t just see India as a destination for trials, but as the heart of clinical excellence and scientific integrity.
TheCconnects: Dr. VijayKumar Gawali, your insights are truly inspiring, and your contributions to clinical research are remarkable. Thank you for sharing your journey and vision with our readers.
Dr. VijayKumar Gawali: It’s been a pleasure. I hope my experiences encourage others to explore the transformative potential of clinical research. Thank you for this platform to share my story.
