TCS ADD™ Metadata Repository
Enabling digital data flow across the clinical value chain by leveraging standards and artificial intelligence (AI)
Products and Platforms
TCS ADD™
TCS ADD™: A Suite of Modern and Open Technology Platforms
Overview
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.
TCS ADD™ team at the India Pharma Awards.
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
Multiple configurable APIs to support end to end Interoperability
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 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.
Our Solutions
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.
- 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).
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.
- 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
- Version Management automated ingestion of new standard versions with built-in capabilities for version comparison and impact analysis
- Flexible and configurable governance model
- Configurable Universal Data Model to define and customize organization’s digital data flow
- Enables integration of Digital Schedule of Activities (SoA) and Biomedical Concepts for seamless data standardization
- Cross-department end-to-end data lineage oversight
- Impact analyzer resolving integrity issues
- Metadata lineage and traceability
- Fastest-ever go-live in the industry for implementing a unified metadata platform
- Regulatory Submission (SDTM) data preparation process was reduced from 4 weeks to 3 days
- 100% compliance to CDISC standards, leveraging ODM to enhance interoperability across clinical systems
- Bi-directional, validated integration with leading EDCs, featuring visual interaction for intuitive form design and editing
- 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
- Supports study design aligned with a well-defined USDM roadmap
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.
