Risk Based Monitoring- a data-centric approach to monitoring
The outbreak and spread of the COVID-19 (SARS-CoV-2) pandemic continues to have a significant negative impact on the clinical trials industry. Restrictions to curb the spread of the virus caused many sites to be temporarily closed to external visits and resulted in postponements and delays to trials. In spite of these challenges, the industry has shown considerable resilience by rapidly deploying alternative strategies to keep clinical research projects on track. Establishing and effectively implementing these strategies continues to be essential not only to ensure the safety and well-being of patients and the continuity of vital clinical research, but also to preserve the integrity of the data generated from this research. In Insights@CromosPharma article our Chief Operating Officer Stephanie Finnegan explores the role of Risk Based Monitoring (RBM) in clinical trials, how it has been utilized in response to the pandemic, and how the experience may shape the industry’s approach to RBM in the future.