Crowne Plaza Geneva, Switzerland | 14 - 15 May 2025 | Booth #21
Industry
Life Sciences
Patient-centered Care Models Taking Center Stage in Life Sciences
Products and Platforms
TCS ADD™
TCS ADD™: A Suite of Modern and Open Technology Platforms
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 is proud to be a Ruby sponsor at the 2025 CDISC + TMF Europe Interchange. Visit us at booth #21 to explore how we automate the clinical value chain from protocol and data collection to submission with the TCS ADD™ Metadata Repository Platform.
TCS expert sessions
Artificial Intelligence for Clinical Data Harmonization
Date and time: May 14, 2025 | 1.30 – 2.00 PM CEST
Speaker:
Rachna Malik
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.
Expert presentation
Date and time: May 15, 2025 | 10:00 - 10:30 AM CEST
Topic: Revolutionizing TFL generation with ARS: Implementation journey and benefits
This session will feature 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. Attendees will gain first-hand insights into how ARS is reshaping clinical reporting standards and driving a paradigm shift in the industry.
Speaker:
Mayank Bhatia
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.
Case in point
US pharma innovator leverages TCS ADD™ Metadata Repository Platform for industry-first AI-powered submissions
Overview
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.
Challenges
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.
Solution
To address these, TCS implemented its next-generation, AI-powered TCS ADD™ Metadata Repository, a comprehensive platform that transforms the way clinical study metadata 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 and ARS controlled terminology, and lab standards—with traceability and version control. Smart governance and real-time monitoring ensured flexibility across different study scenarios while maintaining control and quality.
Key results:
- Automation at scale:
- Achieved 96% automation in SDTM generation across 70+ domains and 81% in ADaM variable allowing for quick, repeatable, and scalable data transformation.
- Accelerated timelines:
- Reduced statistical programming efforts by over 65% and saved 8,100 business hours in the first year alone.
- Compressed SDTM creation from 30 days to 3 (10X) and reduced a six-week, four developer process to just three days (15X), two resource operations
- Regulatory confidence:
- Enabled 100+ transformation types and instant onboarding of Clinical Data Interchange Standards Consortium (CDISC) standards.
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.
