Tata Consultancy Services has launched an agile and intuitive risk-based monitoring solution for clinical trials, that enables intelligent decision making, increased
compliance and improves study efficacy. Part of the TCS ADDTM suite, the new risk-based monitoring solution enables biopharmaceutical and Contract Research Organizations (CROs) to identify study and site risks through advanced statistical algorithms and drive intelligent data driven decisions. The data science led risk-based monitoring solution precisely predicts outcomes pertaining to site workload and risks, thereby enabling stakeholders to lay out proactive monitoring strategies. The novel and intuitive Risk Based Monitoring solution provides insights into missing data, improving data quality and consistency, and enabling early identification of trends and outliers. Sponsors and CROs are expected to realize up to 30% efficiency gain in site monitoring through the solution. In addition, automation speeds up the process, reduces site workload, improves overall compliance, and contributes to product speed-to-market.