Madhavi
15 Sept 2025
Dr. Nagaraj shares insights on regulatory frameworks and operational excellence
Dr. Nagaraj Gowda, Chairman & Managing Director of Abhinavayan Biotech, was invited to speak at the DHR–ICMR sponsored workshop on the Indian Clinical Trial and Education Network (INTENT), held from 15–19 September at Hyatt Pune. The event was organized by KEM Hospital Research Centre, KEM Hospital Pune, and ICMR NITVAR.
Dr. Nagaraj joined a distinguished panel of experts, including Dr. Annam Visala (Joint Drugs Controller, CDSCO), Dr. Sheela Godbole (Director, NITVAR), Dr. Ravindra Ghooi (Director, Scientia Clinical Services), and Dr. Nivedita Gupta (Head of Communicable Diseases, ICMR). The panel focused on how evolving regulatory frameworks can drive innovation, ensure patient safety, and strengthen India’s position in global clinical research.
In his address, Dr. Nagaraj highlighted the regulatory and operational aspects of clinical trials, presenting a pragmatic roadmap that connects recent regulatory updates to real-world implementation. Key themes included:
Enhancing site and investigator readiness
Improving trial registration and transparency
Strengthening data governance practices
Integrating decentralized trial elements
Reducing start-up timelines without compromising patient safety
“Strengthening the bridge between regulation, operations, and patient safety is essential to accelerate innovation while maintaining the highest ethical and scientific standards,” Dr. Nagaraj noted during the discussion.
Participation in such forums reflects Abhinavayan Biotech’s broader commitment to clinical trial strategy, helping design and implement efficient, compliant, and patient-focused trials that accelerate the development of transformative therapies.
The workshop featured engaging talks, interactive discussions, and knowledge-sharing sessions that will help shape India’s clinical research landscape.
