From Data to Dossier: Lessons from Cross-Company Regulatory Submissions
Source category: Submissions & Agencies
Author collections: Nikita Joseph · Gayathri Mahadevan
THE COMMUNITY ARCHIVE
Regulatory Submissions Papers and PresentationsPage 3
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 41–60
From Legacy to ISS/ISE: Real-World Lessons in Module 5 Submissions
Source category: Submissions & Agencies
Author collections: Ajay Gunda · Kishore Pothuri
From Policy to Practice: A Compliance Checklist for EMA Policy 0070
Source category: Submissions & Agencies
Author collections: Anaya Rehman
From XPT to JSON for Submissions: Are We Ready for the Change?
Source category: Data Standards, Governance & Implementation & Submissions & Agencies
GraphStudio: Simplifying the Journey from Clinical Data to Submission-Ready Visuals
Source category: Scripts, Macros & Automation
Harnessing AI to Streamline ClinicalTrials.gov PRS Submissions
Source category: Submissions & Agencies
Author collections: Anaya Rehman
Implementation of Data Standards Using the Estimand Framework
Source category: Data Standards, Governance & Implementation & Submissions & Agencies
Insights and Experience Sharing with Patient-Reported Outcome Data Analysis in FDA’s Submission
Source category: Study Data Integration & Analysis
Author collections: Jingyuan Chen
Investigator-Initiated Trials: Navigating Statistical Programming Challenges with Practical Solutions
Source category: Submission Standards for Global Health Authorities
Author collections: Ramesh Sundaram
Key Guidelines, Tricks and Experiences for the PMDA and a Comparison with FDA and NMPA CDE Submissions
Source category: Submissions & Agencies
Author collections: Ramesh Potluri
Key Programmer Tasks for Japan Submission and Programmer Role Allocation
Source category: Data Standards, Governance & Implementation & Submissions & Agencies
Lessons to Guardrails: Operationalizing Early Checks for FDA Submission Readiness
Source category: Submission Standards for Global Health Authorities
Author collections: Jeff Xia
LLM-Powered Clinical Data Flow with Traceability – From Siloed Pipelines to a Semantic Fabric
Source category: Submissions & Agencies
Author collections: Pankaj Attri · Matt Becker
Managing Commercially Confidential Information Redaction in Contemporary Regulatory Submissions
Source category: Pavilion
Multi-Standard Submission – Process, Learnings and Recommendations for Best Practice
Source category: Submissions & Agencies
Next-Gen Transport Standards: Dataset-JSON from a Programmer’s Lens
Source category: Data Standards, Governance & Implementation & Submissions & Agencies
Author collections: Venkata Koteswara Rao Rayala
One Study, Many Regulators: Submission-Ready Data Package for Multi-Region Filings
Source category: ePosters
Author collections: Himanshu Patel · Chintan Pandya
Open Source as a Strategic Enabler for EMA Submissions: An R Shiny Approach
Source category: Open Source Technologies
Author collections: Marckenley Mercie
Optimising Pinnacle 21 Compliance with Automated Metadata Updates
Source category: Data Standards, Governance & Implementation & Submissions & Agencies
Author collections: Karthik Palani
Optimizing Clinical TFL Review with Python and Power BI: A Reproducible Workflow to Reduce QC Time and Improve Traceability
Source category: Submission Standards for Global Health Authorities
Author collections: Latha Donapati