Artificial Intelligence (AI) continues to evolve at an unprecedented pace, reshaping the way organisations operate, innovate, and make decisions. Among its most transformative advancements are Generative AI (GenAI) and Agentic AI, two complementary paradigms that represent distinct yet synergistic milestones in the evolution of intelligent systems. Within the realm of clinical operations, trial management, and medical or regulatory writing, the convergence of these technologies offers a groundbreaking opportunity to enhance productivity, quality, speed, and compliance across the clinical development lifecycle. This article explores the capabilities of Generative and Agentic AI, their synergistic interplay, and their potential to transform core processes in clinical research and operations. It also highlights practical applications across clinical operations, the anticipated benefits, and the challenges that life science organisations may face when adopting these technologies in real-world settings.

Generative AI has captured widespread attention for its ability to create original content, including text, code, images, audio, and structured data, based on learned patterns from large datasets. Its strength lies in pattern recognition, knowledge synthesis, and creative generation, allowing it to automate complex cognitive tasks such as drafting protocols, summarising clinical data, and generating regulatory or safety reports. In the pharmaceutical, biotechnology, and medical device sectors, GenAI is already assisting in generating the first drafts of clinical study reports, safety narratives, literature reviews, and medical monitoring summaries.