A Practical Approach to Multiple-Period CLINSITE Preparation
Source category: Submission Standards for Global Health Authorities
Author collections: Amanda Plaisted · Sreedhar Bodepudi
THE COMMUNITY ARCHIVE
Regulatory Submissions Papers and Presentations
Browse practical work on assembling, validating and documenting clinical data for regulatory review. Conference examples reflect their publication date; consult current agency guidance when deciding how an approach applies to a new submission.
622 papers · Showing 1–20
Accelerating CDISC SEND Conversion with AI: From Raw Preclinical Data to Regulatory-Ready Datasets
Source category: AI in Pharma, Biotech and Clinical Data Science
Accelerating Regulatory Submissions with R: A Scalable and Compliant Approach
Source category: Emerging Trends & Open Source Technologies
Author collections: Priyanka Sawant
Acquiring a Compound with Multiple Clinical Trials? Let’s Get Ready for a Type C Meeting! Key Considerations for Preparing Its Regulatory Submission
Source category: Submissions & Agencies
Author collections: Mathura Ramanathan · Kajal Tahiliani
Advancing Clinical Trial Analysis with Trimmed Means: Estimands, Intercurrent Events and Regulatory Alignment
Source category: Analytics & Statistics & Analytical Risk-Based Monitoring
Advancing Precision Medicine and Regulatory Readiness: Data Harmonisation and Statistical Methods for Companion Diagnostics Bridging Studies
Source category: Analytics & Statistics
Advancing Transparency‑by‑Design in Clinical Trial Disclosure: Real‑World Applications for Regulatory Submissions
Source category: Pavilion
AI-Driven RBQM: Bridging Operational Excellence and Global Regulatory Demands
Source category: Analytics & Statistics & Analytical Risk-Based Monitoring
AI-Powered Approach for Faster, More Efficient Authoring of Clinical and Regulatory Documents
Source category: Emerging Trends & Innovation
Author collections: Abhijeet Arora · Inderjeet Arora
An AI-Powered Digital Standards Library for Accelerated Regulatory Submissions
Source category: Data Standards, Governance & Implementation & Submissions & Agencies
Author collections: Varun Sethuraman
An End-to-End R-Based Pharmacokinetics (PK) Workflow for Regulatory Submission: The INAVO120 Study
Source category: PK/PD/ADA and Quantitative Pharmacology
Author collections: Shweta Vadhavkar
Anonymisation Strategies for Policy 0070 and PRCI Submissions
Source category: Pavilion
Automating TFL Generation Using R and pharmaRTF: From Data to Submission-Ready TFLs
Source category: Scripts, Macros & Automation
Automation and Macros in Clinical Submissions: Challenges, Limits and the Path Forward
Source category: Scripts, Macros & Automation
Batch Cleaning of SAS Programs for Submission Readiness: An AI and Python Hybrid Approach
Source category: Artificial Intelligence, Machine Learning and Large Language Models
Author collections: Qiong Wei · Qisen Luan
Breaking Free from the xpt: Exploration of Dataset-JSON as an Alternative Transport File to Regulatory Agencies
Source category: Submissions & Agencies
Author collections: Ben Straub
Bridging the Divide: Harmonising HL7 FHIR, OMOP and CDISC Standards for Regulatory-Grade Real-World Evidence
Source category: Data Standards, Governance & Implementation & Submissions & Agencies
Building Cross-Functional Regulatory and Programming Alignment for Successful Submissions
Source category: Submissions & Agencies
Case Study: Leveraging CDISC CORE for Proactive SDTM Compliance and Submission Readiness
Source category: Data Standards, Governance & Implementation
Author collections: Shivani Gupta
CDISC 360i Demo: Automating from Study Design to Submission
Source category: Data Standards, Governance & Implementation
Author collections: Darren Moreland