A Review of Open Source in New Drug Applications: Current Trends
Source category: Submissions & Agencies
Author collections: Philip Bowsher
THE COMMUNITY ARCHIVE
Regulatory Submissions Papers and PresentationsPage 8
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 141–160
A SAS Tool for Generating Adverse Event Summaries in XML Format Using ADaM Datasets ADSL and ADAE for ClinicalTrial.gov and EudraCT Submissions
Source category: Submissions & Agencies
Author collections: Karthika Bhavadas
A Standard Dataset Format in Regulatory Submissions for Clinical Trials: Automatic Creation of Headers, Headers of Headers, and Footnotes
Source category: Scripts, Macros & Automation
Author collections: Kevin Viel
Accelerating Clinical Trial Submissions with Graph Theory and Log Analysis
Source category: Software Demonstrations
Author collections: Henning Kuich · Tomás Sabat Stofsel
ADRG Builder Python Application
Source category: Scripts, Macros & Automation
Author collections: Pierre Dostie
Advancing Regulatory Intelligence with conversational and generative AI
Source category: Solution Development
Author collections: Saurabh Das · Rohit Kadam · Rajasekhar Gadde · Niketan Panchal
Auditing an Open-Source Software Framework in a Regulatory Environment: Challenges, Gaps and Recommendations
Source category: Open Source Technologies
Author collections: Uday Preetham Palukuru · Shahrzad Talebian
Automation of Submission of Programs in Analysis Data Reviewer’s Guide for FDA and PMDA Submissions
Source category: Lectures
Author collections: Junying Zhang
BIMO Brilliance: Your Path to Compliance Resilience
Source category: Submission Standards
Author collections: Jai Deep Mittapalli · Girish Kankipati
Challenges and Considerations When Building e-Submission SDTM Data Packages
Source category: Submission Standards
Author collections: Wei Duan
Clinical Disease Endpoint Flag Implementation for Vaccine Studies
Source category: Submissions & Agencies
Author collections: Charumathy Sreeraman
Combine PDFs in Submission-ready Format Quick and Easy
Source category: Submission Standards
Author collections: Lili Li
Connecting Standard from Design to Analysis to Submission: Finishing the CDISC 360 Vision
Source category: Standards Implementation
Author collections: Peter Van Reusel
Considerations for the Submission of RWD Using CDISC, with Insights from HL7 FHIR and OMOP
Source category: Real-world Evidence
Author collections: Ingeborg Holt · Jeffrey Abolafia
Constructing Multilingual Visualisation Toolsets for Clinical Study Reports and Submission
Source category: Data Visualisation
Author collections: Jane Liao · Bingjun Wang
Creating Adverse Event Tables using R and SASSY System
Source category: Submission Standards
Author collections: Vicky Yuan
Cultivating Success with Non-standard Investigator-sponsored Trial Data for FDA Submissions
Source category: Submission Standards
Author collections: Jai Deep Mittapalli · Jinit Mistry · Venkatesulu Salla
Dataset-JSON as an Alternative Transport Format for Regulatory Submissions
Source category: Poster Presentations
Author collections: Stuart Malcolm · Sam Hume
Deep Dive into the BIMO (Bioresearch Monitoring) Package Submission
Source category: Hands-On Training
Author collections: Mathura Ramanathan · Nancy Brucken
Demystifying Submissions to NMPA China
Source category: Submissions & Agencies
Author collections: Hiral Raval · Dyuthi Yellamraju