As a part of TCS ADD Suite, Tata Consultancy Services (TCS) on Monday launched an intuitive risk-based monitoring solution for clinical trials, that will enable intelligent decision making, increased compliance and improve study efficacy.
The new monitoring solution enables biopharmaceutical and Contract Research Organizations (CROs) to identify site risks through advanced statistical algorithms and drive intelligent data driven decisions. This includes insights into missing data, improving data quality and consistency, providing early identification of trends and outliers. It can precisely predict outcomes regarding site workload and risks, helping stakeholders lay out proactive monitoring strategies.
The solution is expected to aid sponsors and CROs to realize up to 30 per cent 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.
“With Covid 19 critically impacting site visits, life sciences industries realized 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,” Debashis Ghosh, Business Group Head, Life Sciences Healthcare, and Public Services, TCS said.
He added, “With our deep domain knowledge of the life sciences industry, we are continually expanding the capabilities of 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.”
The configuration of the solution includes automated risk management with advanced analytics and visualisations, AI/ML based predictive analytics with 40-plus operational metrics across study, site, subject, data management and budget management categories, providing a holistic performance view across site, country, region, study, program, compound and therapeutic area. And 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.
Published on
April 18, 2022
