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    • TCS ADD™
    • Solution

    TCS ADD™ Metadata Repository

    Enabling digital data flow across the clinical value chain by leveraging standards and artificial intelligence (AI)

    Request for Demo for Solution

    A READY-TO-USE, INTEROPERABLE METADATA DRIVEN AI PLATFORM

    Automates study build, enables robust governance through cross-departmental data lineage and rapidly transforms and generates submission-ready datasets

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    Share AI and Metadata-Driven Ready-To-Use Platform | TCS ADD™ Metadata Repository
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    Products and Platforms

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    TCS ADD™: A Suite of Modern and Open Technology Platforms 

    TCS ADD™  is a suite of modern and open technology platforms for clinical research and drug development that helps make clinical trials more agile and safe. 
    Learn More
     about TCS ADD™: A Suite of Modern and Open Technology Platforms 
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    Related Insights
    Harnessing the Power of AI at TCS Life Sciences Forum 2025 New York
    Hosted by TCS ADD™, the invite-only event will see leaders talk about the role of AI/Generative AI in life sciences. Register for the leadership forum now.
    Events
    14 Feb 2025
    TCS Life Sciences Forum 2024 London: Leveraging AI for Clinical R&D and PV
    Join us at the life sciences event to learn how AI and generative AI can accelerate next-gen clinical R&D and enhance patient safety. Register now for the event.
    Events
    07 Aug 2024
    TCS Life Sciences Forum: Driving Efficiencies and Compliance
    Join us at the TCS Life Sciences Forum to learn how AI-driven RBQM can improve efficiency, ensure compliance, and accelerate your clinical trial journey.
    Events
    04 Feb 2025

    TCS ADD™ EVENT

    TCS at 2025 CDISC + TMF Europe Interchange

    Crowne Plaza Geneva, Switzerland | 14 - 15 May 2025 | Booth #21

    Join us   about   TCS at 2025 CDISC + TMF Europe Interchange

    TCS ADD™ Metadata Repository wins big at the India Pharma Awards. 

    TCS ADD™ Metadata Repository won two awards at the India Pharma Awards, 2023, in the categories of 'Excellence in the use of Technology' and 'Excellence in Ancillary Pharma Services'. The platform was recognized for its leadership in leveraging automation, artificial intelligence (AI), and the Internet of Things (IoT) through its intellectual property and commercial-off-the-shelf offerings. The platform digitizes and transforms patient engagement, metadata management, and regulatory submissions for life sciences organizations.

    Back in 2019, the TCS ADD™ platform received recognition for digitally transforming clinical trials. The India Pharma Awards bring together industry pioneers and recognize exemplary endeavors in innovation that boost the pharma industry.

    Download brochure   Opens in new tab
    TCS ADD™ team at the India Pharma Awards.

    The TCS ADD™ team received the India Pharma Awards 2019 and 2023 for TCS ADD™ Metadata Repository. The India Pharma Awards provides a platform for the pharma industry pioneers in innovation.

    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 the trial

    Impact analyzer that assesses the 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.

    TCS ADD™’s vision is to enable digital data flow by automating all deliverables from protocol and data collection to submission.

    In focus

    Integrating AI and ML into SDTM transformations

    Learn about automating SDTM transformation setup for studies with metadata repository framework for seamless exchange & submission of clinical trial.

    Click to know more

    Digital Data Flow & Tech Solution Providers

    Learn how Digital Data Flow (DDF) initiative can digitize information for clinical research & streamline study protocol processing through automation.

    Click to know more

    Metadata management from storage to integration

    In this blog post, we will explore how a metadata repository can leverage advanced technologies to make metadata management easier and more efficient.

    Click to know more

    Speeding up to market with Metadata Repository

    The blog discusses a few unique ways how MDR accelerates clinical study setup.

    Click to know more

     

    Our Solutions

    Scalable Metadata Repository (MDR) for multiple standards and templates, including source collection EDC [(Electronic data capture) and non-EDC(Electronic data capture)], SDTM(Study Data Tabulation Model), and ADaM(Analyst Data Model).

    • Provides capability to maintain company references such as treatment standards or lab reference ranges.
    • End-to-end visual lineage helps to track data dependency and assess impact at an element level.
    • A robust and configurable governance framework to manage company-specific workflows.
    • Highly intuitive and customizable UI.
    • Provides functionality to define role-based access on different studies and standards to users or groups with an option for Single Sign-On (SSO).
    Read more

    Automated study design based on standards and templates via bidirectional integration to the EDC system. Bidirectional integration also allows users to compare metadata set up in MDR and EDC.

    Read more

    Automated creation of ready to use study setup for SDTM, ADaM using standards and cognitive technologies like AI/ML with industry leading accuracies. This includes functionalities such as extracting the transformation metadata based on standards, identifying target structures, and predicting transformation metadata for a new source database. By automating these transformation processes, we streamline metadata management, reduce errors, and accelerate the analysis submission process.

    Read more

    Interconnected CRF, SDTM, ADaM data models across the entire study lifecycle.

    • Visualizing the relationships between different data elements like CRF to SDTM linkage, showing how they interact and depend on each other.
    • Assessing the potential effect of changes to data sources or transformations, helping organizations to understand the implications before making changes.

    highlights

    • Automated study setup for SDTM and ADaM
    • Real-time SDTM availability
    • Flexible and configurable governance model
    • Cross-department end-to-end data lineage oversight
    • Impact analyzer resolving integrity issues
    • Metadata lineage and traceability

    BENEFITS

    • Fastest-ever go-live in the industry for implementing a unified metadata platform
    • The regulatory Submission (SDTM) data preparation process was reduced from 4 weeks to 3 days
    • 100% compliance with Clinical Data Interchange Standards Consortium (CDISC) standards
    • Up to 3-6 weeks’ time reduction in EDC study build efforts
    • Up to 30% cost saving in EDC study builds efforts
    • Up to 70% decrease in SDTM efforts
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    Merging the best of both worlds 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 India Pharma Awards in 2019, 2021, 2022, 2023, and 2024

    TCS ADD™ wins India Pharma Awards in 2019, 2021, 2022, 2023, and 2024

    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

    01 - 01

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