Achieve Seamless Clinical Data Flow with AI-led TCS ADD™ Metadata Repository Platform: From Protocol to CSR
The 2025 CDISC + TMF Europe Interchange is a premier industry event that brings together global life sciences professionals, including leading pharmaceutical companies, regulatory agencies, and technology providers.
TCS proudly participated as a Ruby sponsor at the 2025 CDISC + TMF Europe Interchange. Visitors explored how we automate the clinical value chain from protocol and data collection to submission with the TCS ADD™ Metadata Repository Platform at booth #21.
TCS expert sessions
Session Title: Artificial intelligence for clinical data harmonization
Explored how Al-driven data unification is playing a critical role in accelerating clinical trials, making them more efficient and effective and emphasized how intelligent insights can enhance patient safety and improve success rates.
Global head, TCS ADD™, TCS
Rachna Malik is the Vice President and Global Head of the TCS ADD™ Platform at Tata Consultancy Services, a global leader in IT services, consulting, and business solutions. The TCS ADD™ Platform offers innovative technology solutions to pharma companies for digitizing clinical trials. The platform, powered by artificial intelligence, accelerates the clinical R&D value chain and makes clinical trials more agile and safe.
Session Title: Revolutionizing TFL generation with ARS: implementation journey and benefits - won the 2nd best paper presentation at the 2025 CDISC + TMF Interchange
This session featured an exclusive case study of ARS implementation in a leading pharmaceutical company, detailing the remarkable benefits observed during the Proof of Concept (PoC) phase and the seamless transition to full-scale production by mid-2025.
Head, TCS ADD™ Metadata Repository, TCS
Mayank Bhatia has over 22 years of clinical experience and is the Head of Product Strategy and Management in the TCS ADD™ Metadata Repository. His expertise spans building products and platforms, leading cross-functional teams, achieving operational excellence, and driving change for transformational programs. He has successfully led and delivered many large-scale and critical transformational programs. He holds a bachelor’s degree in computer science and is PMP-certified.
What’s in store
This year’s program will feature critical discussions on AI-driven automation, regulatory compliance, the evolving landscape of clinical data standards on the European clinical research landscape, AI and automation, digital data flow, ADaM dataset optimization, ARS, and advancements in Trial Master File (TMF) management.
To schedule a meeting with our product experts, write to us @ add.platform@tcs.com or meet us at booth #21 at the 2025 CDISC + TMF Europe Interchange.
About us
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.
US pharma innovator leverages TCS ADD™ Metadata Repository Platform
A large, innovation-driven US pharmaceutical company transformed its clinical trial submission process by implementing TCS’s AI-powered TCS ADD™ Metadata Repository Platform, setting a new industry benchmark.
The company faced several operational challenges, including fragmented standards, manual dataset generation, rising trial volumes, increasing compliance complexity, and limited automation. These issues caused inefficiencies, delayed submissions, and heightened regulatory risks thereby slowing down drug development timelines.
To address these, TCS implemented its next-generation, AI-powered TCS ADD™ Metadata Repository, a comprehensive platform that transforms the way clinical standards metadata, study metadata and transformation specs is managed, standardized, and submitted.
The platform included advanced AI and cognitive automation modules that helped automate the creation of submission-ready SDTM and ADaM datasets. As a foundation, the TCS ADD™ platform deployed a clinical standards metadata registry that manages metadata across the clinical data lifecycle. This included source data collection, SDTM, ADaM, ARS, controlled terminology, and lab standards—with traceability, transformation specs and version control. Smart governance and real-time monitoring ensured flexibility across different study scenarios while maintaining control and quality.
Automation at scale:
Accelerated timelines:
Regulatory confidence:
This enterprise-wide transformation not only redefined the sponsor's clinical data submission approach but also set a new standard for the pharmaceutical industry’s digital evolution.
