2026 India CDISC Day Program
9:00 - 10:00
Session 1: Opening Plenary & Keynote Presentation
Chairs: Deepak Venkataraman, Gaurab Chakraborty
9:00 - 9:30
Registration & Welcome Coffee
9:30 - 10:00
Keynote Presentation
Patti Compton, Pfizer Inc., CDISC Board of Directors
10:00 - 11:00
Session 2: CDISC 360i / Digital Data Lifecycle Demonstrations
Chair: Raghu Kishor Koukuntla
10:00 - 10:20
CDISC 360i Vision in Practice: Open Source Tools from USDM to SDTM
Chaitanya Pradeep, AI Lens Tech Private Limited
10:20 - 10:40
Biomedical Concepts: The Barcode for Clinical Data
Ramya Gangadi, Ephicacy Lifesciences
10:40 - 11:00
Intelligent Agentic AI for Clinical Data Management: From Data Collection to Regulatory Submission
Rishi Raj, SENSAN Biosciences Pvt. Ltd.
11:00 - 11:15
Networking Break
11:15 - 11:55
Session 3: CDISC Foundational Standards
Chair: Linga Reddy Aenugu
11:15 - 11:35
SEND 4.0 Unleashed: The Next Evolution in Nonclinical Data Standards
Anuj Gandhi, Cliantha Research
11:35 - 11:55
Designing the Future of Clinical Data Workflows: Transforming CDISC Standards into Actionable User Experiences
Narendra Parmar, Sycamore Informatics
11:55 - 13:00
Lunch
13:00 - 13:40
Session 4: Open Source Usage, Including CORE, OAK, ARS, COSMoS
Chair: Chaitanya Repaka
13:00 - 13:20
A Modular, Open-Source Approach to Streamline QA of CDISC-Compliant TLFs Using TEAL
Mahesh Krishna, GSK
13:20 - 13:40
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
13:40 - 14:20
Session 5: Submission & Integrated Lifecycle Workflows
Chair: Nakul Kamath
13:40 - 14:00
Global Regulatory Landscape for Clinical Data Submissions: FDA, PMDA, EMA, and NMPA Perspectives on AI-Enabled Submission Readiness
Shirisha Sugavasi, Ephicacy Life Sciences
14:00 - 14:20
Beyond Compliance: What Really Makes a Submission Review-Ready: Lessons learned from Regulatory Deliverables
Nilakshi Srivastava, Pfizer
14:20 - 15:00
Session 6: AI/ML Applications in Clinical Data Workflows
Chair: Ajay Daparthi
14:20 - 14:40
From Hours to Minutes: Automating SDRG and ADRG Creation with Gen-DRG
Vaishali Govindarajan, Zifo RnD Solutions
14:40 - 15:00
Automating ADNCA Dataset Preparation with Per-Step CDISC Conformance Gates
Ragav Rajan, PumasAI
15:00 - 15:15
Networking Break
15:15 - 15:55
Session 7: CDISC Vision
Chair: Vipin Gupta
15:15 - 15:35
CDISC 360i Phase 2: Lessons Learned and the Road Ahead
Peter Van Reusel, CDISC CSO
15:35 - 15:55
Analysis Concepts Presentation
Edwin van Stein, CDISC
15:55 - 17:00
Session 8: Moderated Panel Discussion & Closing Plenary
Chair: Jeba Kumar
15:55 - 16:55
Panel Discussion: The Future is Connected: Standards and AI Powering Digital Transformation
Moderated by: Jeba Kumar
Panelists:
- Patti Compton, VP & Global Head of Statistical Data Sciences and Analytics, Pfizer Inc.
- Peter Van Reusel, Chief Standards Officer, CDISC
- Edwin van Stein, Statistical SME and USDM Content Lead, CDISC
- Kannan Natarajan, Head of Data Science and Analytics, Pfizer Inc.
- Tara Gladwell, Ephicacy
- Pankaj Tyagi, Sycamore Informatics
- L Balasubramanian, Eli Lilly
16:55 - 17:00
Closing Remarks