Tata Consultancy Services (TCS) has launched a risk-based monitoring solution for clinical trials that applies AI to a range of metrics from remote sites across different regions and countries to improve trials compliance and study quality. Tests of the remote site monitoring solution show improvements in clinical trials efficiency of up to 30%.

Part of the TCS ADD suite, the new risk-based monitoring solution enables biopharmaceutical and Contract Research Organisations (CROs) to identify study and site risks through advanced statistical algorithms and drive intelligent data driven decisions.

The risk-based monitoring solution includes intelligent risk management that facilitates automated triggers for outliers with advanced analytics and visualisations, and AI/ML based predictive analytics with leading indicators of site monitoring workload analytics.

Some 40+ operational metrics are monitored across study, site, subject, data management and budget management categories to provide a holistic performance view across site, country, region, study, programme, compound and therapeutic area. A one-click communication module that provides a unified and collated list of pending activities, and system generated intelligent actions across all source systems; driving greater engagement and collaboration.

According to TCS, the clinical trials monitoring solution can boost efficiency in trials efficiency by up 30% through remote site monitoring.

“With COVID 19 critically impacting site visits, life sciences industries realised the value of remote Risk Based Monitoring solutions that empower sponsors to monitor trials centrally, assess the risks and track corrective actions to enhance study quality,” said Debashis Ghosh, Business Group Head, Life Sciences Healthcare, and Public Services, TCS. “With our deep domain knowledge of the life sciences industry, we are continually expanding the capabilities of our modern and open TCS ADD platform to include data science, artificial intelligence and machine learning led clinical operational analytics solutions that transform the drug development value chain, deliver greater value for our customers and achieve faster compliance.”