R Consortium’s R-Based Test Submission Package for FDA Evaluation: A Milestone and a New Frontier in R-Based Regulatory Submissions
Source category: Poster Presentations
THE COMMUNITY ARCHIVE
Regulatory Submissions Papers and PresentationsPage 7
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 121–140
Redefining FDA Submissions: The Future of Interactive R Shiny Dashboards
Source category: Emerging Trends
Author collections: André Veríssimo · Vedha Viyash
Regulatory Challenges and Strategies for AI/ML-Enabled Medical Device (SaMD) Data Submission
Source category: Submissions & Agencies
Author collections: Shashikant Kumar · Mrityunjay Kumar
Regulatory Submissions – Exciting, Challenging, or Both?
Source category: Submissions & Agencies
Author collections: Randi McFarland
Simplify, Automate, Submit: An In-House Framework for Seamless Metadata Flow from (Pre)Production to Submission
Source category: Standards Implementation (SI)
SM09 Automating RTF-to-PDF Conversion for BIMO Submissions: A Python-Based End-to-End Solution
Source category: Scripts, Macros & Automation (SM)
Author collections: Yi Yan
Solving Real-World Data (RWD) Reliability Challenges for Use in Regulatory Decision-Making
Source category: Data Handling & Engineering
Author collections: Mayur Saxena · Tasha Nagamine
Succeed with gridify: Enriching R Visualisations for Regulatory Submissions
Source category: Open Source Technologies (OS)
Author collections: Alexandra Wall
The Art of Timely Deliverables: How We Learned To Stop Worrying and Love the Deadline
Source category: Submissions & Agencies (SA)
The Role of Quantitative Bias Analysis (QBA) in Ensuring the Reliability of Real-World Evidence (RWE) in Regulatory Submissions
Source category: Analytics & Statistics
Author collections: Tasha Nagamine
The Show Must Go On: Best Practices for Submitting SDTM Data for Ongoing Studies
Source category: Submission Standards
Author collections: Kristin Kelly
The Show Must Go On: Best Practices for Submitting SDTM Data for Ongoing Studies
Source category: Submissions & Agencies (SA)
Author collections: Kristin Kelly
The Show Must Go On: Best Practices for Submitting SDTM Data for Ongoing Studies
Source category: Submissions & Agencies
Author collections: Kristin Kelly
The Value of Clinical Trial Data: From Submission to Innovation
Source category: Data Handling & Data Engineering (DH)
Author collections: Anne Katrine Alsing
Towards an Integrated Submission-Ready Data Pipeline: Unifying Compliance, Automation, and Open-Source Innovation
Source category: Strategic Implementation & Innovation
Author collections: Shivani Gupta · Bhavin Busa
Updating Define-XML packages: Tips and A Comprehensive Checklist
Source category: Submission Standards
Using CDISC USDM and BCs to Select Data from Alternative Data Sources for Regulatory Purposes
Source category: Data Standards & Governance (DS)
Author collections: Berber Snoeijer
Using the USDM and Ensuring Governance and Traceability to Unlock the Potential of Real-World Data Sources for Regulatory Submissions
Source category: Real-world Evidence
Author collections: Alistair Dootson · Berber Snoeijer
Validated Statistical Computing: A Kubernetes Framework for Regulatory-Compliant R, Python and SAS Deployments
Source category: Trends & Technology (TT)
Author collections: Randy Betancourt
A Programmer’s Insight into an Alternative to TQT Study Data Submission
Source category: Submission Standards
Author collections: Raghavender Ranga