TCS ADD™ Metadata Repository
Enabling digital data flow across the clinical value chain by leveraging standards and artificial intelligence (AI)
TCS ADD™ Metadata Repository is a groundbreaking platform, a first for the industry to address challenges in metadata management and clinical study setup for the pharmaceutical domain. The platform optimizes workflows, enhances data quality, ensures compliance with industry standards, and accelerates study timelines. Key elements encompass end-to-end clinical metadata management (From data collection to tables, listings, and figures (TLF), intuitive mappings, real-time data accessibility, and AI-driven automation for generating submission-ready SDTM (Study Data Tabulation Model) and ADaM (Analysis Data Model) datasets.
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.
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
Multiple configurable APIs to support end to end Interoperability
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 in generating study data tabulation models (SDTM), Analysis Data Model (ADaM) and Tables, Figures and Listing (TFLs). 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 to data collection to submission.
Scalable Metadata Repository (MDR) for multiple standards and templates, including source collection EDC (Electronic data capture) and non-EDC, SDTM (Study Data Tabulation Model), ADaM (Analyst Data Model) and Analysis Results Datasets Standards (ARDS) based on metadata driven approach.
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.
Study snapshot feature enables to take snapshot of all metadata elements of entire study for future reference.
Automated creation of ready to use study setup for SDTM, ADaM transformation mappings 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.
Interconnected CRF, SDTM, ADaM data models across the entire study lifecycle.
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.