Clinical trial monitoring is facing challenges due to the increased complexity of trials and an increasing number of data sources. This has resulted in operational inefficiency and difficulties in signal detection. Siloed systems, time-consuming study onboarding activities, lack of required skillsets, and limited AI/ML capabilities are hampering conducting clinical trials efficiently and impacting costs and quality adversely. Manual review processes, absence of end-to-end workflows, and difficulties in bringing in cross-functional collaboration are delaying the adoption of risk-based monitoring strategies.
The clinical trial industry is facing unique challenges today due to high data volume and complexity, making clinical trial oversights inefficient and costly.
The TCS ADD™ Risk-Based Quality Management platform accelerates new drug/therapy development timelines. The platform provides the products and technology to enhance risk assessment, monitoring, quality control, compliance, site performance, and clinical and operational data analytics capabilities. Our unique platform approach allows flexibility, enabling organizations to adapt the tools that best meet their immediate needs while gradually integrating a comprehensive risk-based quality management (RBQM) solution.
Some of the features of the platform include:
TCS ADD™ Risk-Based Quality Management platform is powered by four cutting-edge components encompassing end-to-end risk assessment, statistical monitoring, and mitigation of risk.
The TCS ADD™ Risk-Based Quality Management platform commands global usage covering several therapeutic areas. The key benefits include:
Increased efficiency and reduced workload
Improved data quality and oversight
Meaningful insight and prevention of issues
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