Skip to main content
Skip to footer
We're taking you to another TCS website now.

Press Release

TCS Launches Risk-Based Monitoring Solution that Transforms Clinical Operational Analytics and Enhances Study Quality
Read More



TCS ADD™ Risk-Based Monitoring Solution

An agile, efficient and intelligent solution for clinical operational analytics and risk-based study execution

Platform live for:
300+ Studies
3000+ Global Users
30,000+ Sites

Error: unable to play the video



Traditional and archaic on-site monitoring activities

The life sciences industry is facing multiple challenges and inefficiencies due to predetermined and fixed schedules of site monitoring. In addition, with the frequency of monitoring not linked to variations in risk or workload at a particular site, clinical study conduct is severely impacted. Traditional site monitoring involves the use of lagging indicators that leverage historical data and do not provide a precise assessment of site performance. Lastly, manual and time-intensive resource allocation and planning add to the overall workload and inefficiencies.


TCS Solution

Agile, intelligent, and efficient solution for operational analytics and risk-based study execution

The Risk-Based Monitoring, data science-driven collaborative platform from TCS ADD™ enables risk-based quality management driven by predictive analytics and facilitates the early detection of risks and proactive monitoring strategies. It comprises the following key components:

  • Intelligent risk management that facilitates automated triggers for outliers with advanced analytics and visualizations
  • AI/ML-led predictive analytics with leading indicators of site monitoring workload analytics 
  • More than 40 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 areas
  • A one-click communication module that provides a unified and collated list of pending activities, and system-generated intelligent actions across all source systems



Connect with us to transform your workplace

*Required field
*Enter valid First Name
First Name
*Required field
*Enter valid Last Name
Last Name
*Required field
*Email syntax error
*Please use your business email.
*Required field
*Enter valid company name
Company Name
What's your challenge

Thank you for your interest

We will shortly connect.

Click here to submit another form.


Unlocking the value of data for the life sciences industry














Plug-and-play orchestration

Plug and play orchestration

Cross-solution integration

Cross-solution integration




“When you actually use artificial intelligence to predict site and risk workload, this proactive and predictive approach clearly augments the way and empowers the end-users to perform effective site monitoring.”

-Dr. Niraj Vyas
AVP & Head, TCS ADDTM Analytics & Insights, TCS


Dynamic monitoring in clinical trial oversight

TCS ADD™ co-hosted a virtual event with Janssen to provide a data science-led insights approach to risk-based monitoring in clinical trials. Thought leaders from AbbVie, Bristol Myers Squibb, Janssen, MSD, Triall, and TCS presented their views on the role played by predictive analytics and AI in dynamic monitoring and oversight of clinical trials.

Error: unable to play the video