Regulatory Submissions Papers and PresentationsPage 4

Post-DBL Programming Update Tracker: Automating Revision Capture to Strengthen Audit Readiness, Oversight, and Compliance Across Programs and ADaM Specifications

Yunyi Jiang; Christine Teng

Source category: Submission Standards for Global Health Authorities

Author collections: Yunyi Jiang · Christine Teng

Programming Challenges in Developing PRO Analysis Datasets Under FDA’s New Submission Guidance

Weiwei Guo; Caizhi Huang

Source category: Advanced Programming

Author collections: Weiwei Guo

R-Based Translation of Japanese Characters in Clinical Datasets for Regulatory Reporting

Hardik Sheth; Roshan Stanly

Source category: Emerging Technologies (R, Python, GitHub etc.)

Author collections: Hardik Sheth · Roshan Stanly

Reproducible RWE at Scale: From Fragmented Data to Regulatory-Ready Insights

Agnes Youn

Source category: Software Demonstrations

RIP – Inconsistent Metadata Specifications with RAP (R And Python). Generate Specs Faster and Detect Early Errors to Speed Up Submissions

Kairav Tarmaster

Source category: Emerging Trends & Open Source Technologies

Author collections: Kairav Tarmaster

Smarter, Faster, Better: GenAI‑Driven Authoring for Data Reviewer’s Guides

Christina Scienski; Christine Rossin

Source category: ePosters

Author collections: Christina Scienski · Christine Rossin

Solving the Fragmentation Challenge in Rheumatoid Arthritis (RA) Trials: Deriving Deeper Insights

Kirankumar Vyas

Source category: Data Standards, Governance & Implementation & Submissions & Agencies

Author collections: Kirankumar Vyas

Standardisation of Auxiliary Medicinal Products (AxMPs) in Clinical Trials

Divya Mekala; Manoj Mishra

Source category: Data Standards, Governance & Implementation & Submissions & Agencies

Structure for Success: Delivering a Complex, Accelerated NDA with Evolving Scope

Tingting Tian; Chao Su; Erica Davis

Source category: Submission Standards for Global Health Authorities

Author collections: Tingting Tian · Chao Su · Erica Davis

Submitting eCRT SDTM Data for ISS

Aida Swierk

Source category: Submissions & Agencies

The Expanding Role of Real-World Evidence (RWE) in Supporting Regulatory Submissions

Nikhil A; Setu Sagar

Source category: Real-world Evidence & Data Visualisation

Transforming Legacy Data into CDISC Standards: Practical Approaches and Regulatory Insights

Khalif Halani; Veena Palle

Source category: Data Standards, Governance & Implementation

Author collections: Veena Palle

Trends in eSub Evaluation Findings: A Twenty-Year Perspective on Data Traceability

Lisa Brooks; Piper Brooks

Source category: Submissions & Agencies

Author collections: Lisa Brooks

Unified Meta-Study: Harmonising Clinical Biomarker, Genomics and Clinical Trial Data for Enhanced Access, Usability and Life Cycle Management

Namrata Padmashali

Source category: Data Standards, Governance & Implementation & Submissions & Agencies

A collaborative and agile approach for end to end Standards Governance and Release

Kairav Tarmaster; Pratiksha Wani

Source category: Submission Standards

Author collections: Kairav Tarmaster

A Little Bit of This and That: Use cases, implementation, and documentation when using multiple CDISC standards, CTs, and regulatory guidances in an SDTM study

Charity Quick

Source category: Submission Standards

Author collections: Charity Quick

Accelerating Data Discovery and Governance: Unlocking Insights with Metadata Management, Data Catalogs, and LLM Integration for Streamlined Regulatory Approval in Clinical Trials

Pritesh Desai; Samiul Haque

Source category: Metadata Management

Author collections: Pritesh Desai · Samiul Haque

ADaM and TFLs for Drug-induced Liver Injury (DILI) Analysis

Song Liu; Rambabu Sura

Source category: Submission Standards

Author collections: Song Liu · Rambabu Sura

AI Ethical Considerations in Drug Development and Regulatory Review

Tara Chavda; Qingying Ally Lu

Source category: Machine Learning, AI and Large Language Models

Author collections: Tara Chavda · Qingying Ally Lu

Automating Define-XML Updates: A SAS-Based Framework for Submission Readiness

Qiong Wei; Lixin Gao

Source category: Metadata Management

Author collections: Qiong Wei · Lixin Gao