Risk-Based Monitoring Pilots in Indian Clinical Trials: Trends, Challenges, and Regulatory Outlook
Risk-Based Monitoring Pilots in Indian Clinical Trials: Trends, Challenges, and Regulatory Outlook India’s Evolving Approach to Risk-Based Monitoring in Clinical Trials Introduction Risk-Based Monitoring (RBM) has emerged as a transformative strategy in global clinical trial oversight. Traditionally, Indian trials have relied on 100% Source Data Verification (SDV) with frequent onsite visits. However, as the complexity…