How evolving regulations, digital transformation, and global partnerships are positioning India at the forefront of clinical innovation. Over the past decade, India has emerged as one of the most promising destinations for global clinical research . With its vast patient population, diverse disease profiles, and expanding network of research-ready institutions, the country offers a unique environment for conducting high-quality, cost-effective, and ethically compliant clinica

Published by IDDCR Global Research CRO Insights | November 2025 Introduction Artificial Intelligence (AI) has moved from a futuristic concept to a fundamental enabler of efficiency and accuracy in drug development and pharmacovigilance . From automated case intake to predictive signal detection, AI systems are now deeply integrated into how the life sciences industry manages patient safety and regulatory compliance. However, as these technologies mature, regulatory authoritie

By IDDCR Global Research CRO Insights Team Introduction: A New Era in Regulatory Submissions In the world of drug development, regulatory submissions are the crucial bridge between innovation and patient access. Over the past two decades, the Common Technical Document (CTD)  and its electronic version, eCTD , have served as the global gold standard for dossier submissions to regulatory authorities such as the FDA , EMA , MHRA , and CDSCO . Now, with the introduction of eCTD V

In today’s rapidly evolving pharmaceutical and biotechnology landscape, Contract Research Organizations (CROs)  play a pivotal role in bridging the gap between scientific innovation and regulatory compliance . As new therapies emerge from cutting-edge research—ranging from gene editing and biologics to AI-driven drug discovery—the path from laboratory to patient is becoming increasingly complex. CROs act as strategic partners, helping sponsors navigate this journey efficientl