Critical utility of e-solutions in risk based monitoring


  • Pranjal R. Chaturvedi SME, Risk Based Monitoring, Tata Consultancy Services Ltd, India



Source data verification, Risk based monitoring, Good clinical practices


As the clinical trial industry is evolving from a traditional 100% SDV (source data verification) approach to reduced SDV & Centralized Monitoring by applying a risk based monitoring (RBM) approach, hence forth leveraging of e-Solutions and real time data integrations would be critical in RBM. Technological considerations are critical to collect data real time to assess, monitor and mitigate risk in compliance with Good Clinical Practices. This article will examine the importance of e-Solutions and real time analytics in alignment with various systems for developing an effective RBM strategy.


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