IT services, consulting and business solutions organisation Tata Consultancy Services (TCS) has introduced a risk-based monitoring solution for clinical trials. 

The swift and intuitive solution is part of the TCS ADD suite and enables intelligent decision making, enhances compliance and boosts the efficacy of the study.

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Biopharmaceutical and contract research organisations (CROs) can use the solution to detect risks linked to trials and sites using improved statistical algorithms, as well as make intelligent data-driven decisions. 

Furthermore, the data science-steered solution accurately forecasts outcomes related to site workload and risks, allowing stakeholders to plan proactive monitoring approaches.

The solution comprises intelligent risk management, which enables automated triggers for outliers using innovative visualisations and analytics.

It also has predictive analytics based on artificial intelligence (AI) / machine learning (ML) and more than 40 operational metrics across the trial, subject, site, data management and budget management segments.

In addition, the solution’s one-click communication module offers a combined and organised list of pending tasks, as well as system-created intelligent actions across all source systems.

The system offers insights into missing data, boosts data quality and consistency, as well as allows early detection of trends and outliers. 

By leveraging this solution, sponsors and CROs are expected to increase efficiency by up to 30% in site monitoring. 

TCS Life Sciences Healthcare and Public Services business group head Debashis Ghosh said: “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. 

“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.”