2026 India CDISC Day Presentation Archive
The 2026 India CDISC Day has concluded. We hope to see you next year!
Session 1: Opening Plenary & Keynote Presentation
Chairs: Deepak Venkataraman, Gaurab Chakraborty
Keynote Presentation
Patti Compton, Pfizer Inc., CDISC Board of Directors
Session 2: CDISC 360i / Digital Data Lifecycle Demonstrations
Chair: Raghu Kishor Koukuntla
CDISC 360i Vision in Practice: Open Source Tools from USDM to SDTM
Chaitanya Pradeep and Koushik Grandhi, AI Lens Tech Private Limited
Biomedical Concepts: The Barcode for Clinical Data
Ramya Gangadi, Ephicacy Lifesciences
Intelligent Agentic AI for Clinical Data Management: From Data Collection to Regulatory Submission
Rishi Raj, SENSAN Biosciences Pvt. Ltd.
Session 3: CDISC Foundational Standards
Chair: Linga Reddy Aenugu
SEND 4.0 Unleashed: The Next Evolution in Nonclinical Data Standards
Anuj Gandhi, Cliantha Research
Designing the Future of Clinical Data Workflows: Transforming CDISC Standards into Actionable User Experiences
Narendra Parmar, Sycamore Informatics
Session 4: Open Source Usage, Including CORE, OAK, ARS, COSMoS
Chair: Chaitanya Repaka
A Modular, Open-Source Approach to Streamline QA of CDISC-Compliant TLFs Using TEAL
Mahesh Krishna and Saravanakumar LT, GSK
A Cloud-Native, Containerized Clinical Programming Platform That Provides On-Demand SAS/R Environments, Integrated with Git-Based Source Control and Governed Clinical Data Access
Prasanna P, Syneos Health
Session 5: Submission & Integrated Lifecycle Workflows
Chair: Nakul Kamath
Global Regulatory Landscape for Clinical Data Submissions: FDA, PMDA, EMA, and NMPA Perspectives on AI-Enabled Submission Readiness
Shirisha Sugavasi, Ephicacy Life Sciences
Beyond Compliance: What Really Makes a Submission Review-Ready: Lessons learned from Regulatory Deliverables
Nilakshi Srivastava and Priyadarshini Sankar, Pfizer
Session 6: AI/ML Applications in Clinical Data Workflows
Chair: Ajay Daparthi
From Hours to Minutes: Automating SDRG and ADRG Creation with Gen-DRG
Deepika Ravichandran, Zifo RnD Solutions
Automating ADNCA Dataset Preparation with Per-Step CDISC Conformance Gates
Ragav Rajan and Sharath Kumar, PumasAI
Session 7: CDISC Vision
Chair: Vipin Gupta
CDISC 360i Phase 2: Lessons Learned and the Road Ahead
Peter Van Reusel, CDISC CSO
Analysis Concepts Presentation