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India Pharma Award 2019

Features

Integrated standards and study build

Single source of data in a central repository with cross-departmental data lineage

Intuitive mapping enabling SDTM setup even before the start of trial

Impact analyser that assesses effect of any change by referencing its metadata lineage

Challenge

Pharma organizations need to improve standard compliance and governance through automation.

Across the entire study build process, pharma companies deal with non-standard data, manual programming, and disjointed downstream processing that lead to increased process time of the study data tabulation models (SDTM). As a result, pharma companies are looking for an automated and integrated, metadata-driven, end-to-end solution leveraging clinical standards as the driving force.

 

Our Solutions

Metadata repository for multiple templates and standards, cross-study, and product reusability 

Automated study design from standards and templates with bidirectional integration to EDC such as RAVE and Inform

Automated creation of ready-to-use submission packages using cognitive technologies such as AI and ML

Intuitive metrics to assess the usability of standards 

  • Automated study setup build
  • Real-time SDTM availability 
  • Standard library with smart governance 
  • Improved data quality and oversight 
  • Increased compliance with regulatory standards
  • Up to 3-6 weeks’ time reduction in EDC study build efforts
  • Up to 30%, cost reduction in EDC study build efforts
  • Up to 70% reduction in SDTM efforts
Merging the best of both worlds together i.e., pharma and technology can significantly enhance and accelerate the entire drug development process and build on patients’ belief of a better tomorrow.
Rachna Malik

Global Head, TCS ADD Platforms

RECOGNITION

TCS ADD wins the 2021 India Pharma award

TCS ADD wins the 2021 India Pharma award

TCS ADD Safety wins the 2020-21 Awards.AI for using AI to re-imagine pharmacovigilance

TCS ADD Safety wins the 2020-21 Awards.AI for using AI to re-imagine pharmacovigilance

TCS ADD Connected Clinical Trials platform wins the 2020 Citeline Award

TCS ADD Connected Clinical Trials platform wins the 2020 Citeline Award

TCS' ADD Connected Clinical Trials platform wins the European Innovations Award

TCS' ADD Connected Clinical Trials platform wins the European Innovations Award

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