BIMO Package: Challenges and Perspectives while keeping up with the upgrades in the BIMO Technical Conformance Guide and the BDRG Guidelines
Source category: Submission Standards
Author collections: Mathura Ramanathan
THE COMMUNITY ARCHIVE
Regulatory Submissions Papers and PresentationsPage 11
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 201–220
CDISC Conformance and Compliance: So Many Resources, So Little Time!
Source category: Submission Standards
Author collections: Jennifer Fulton · Stephen Black
Consistency Checks Automation across Regulatory Submission Documents in the eCTD M5 folder
Source category: Submission Standards
Author collections: Majdoub Haloui · Hemu Shere
Content Authoring Automation for Productivity Gains, Improved Quality and Lesser Submission Delays Using Advanced NLP Techniques
Source category: Emerging Trends
Author collections: Debiprasad Roy
Data Profiling Made Shiny – Accelerating Clinical Study Delivery and Submission
Source category: Poster Presentations
Delivering Electronic Submissions (eSubs) in Light Speed: Days Rather than Months
Source category: Submissions & Agencies
Author collections: Christine Rossin
Detroit, Michigan: A Case Study for DEI Via Decentralised Clinical Trials (DCTs)
Source category: Submissions & Agencies
Author collections: Mark Rothe
Development Safety Update Report (DSUR)/Periodic Safety Update Report (PSUR)
Source category: Submissions & Agencies
Author collections: Phillip Spowart
Digging Deep into Digital Biomarkers: Empowering Clinical Trials
Source category: Beyond Submissions Stories
Author collections: Vijay Pasapula
Drafting Your Plain Language Summaries: Hurdles to Overcome and How to Overcome Them
Source category: Submissions & Agencies
Experiencing the FDA CBER
Source category: Submissions & Agencies
Author collections: Angelo Tinazzi
F2: FAIR and Filing – Assessing Data Fitness for FAIR and Filing
Source category: Submission Standards
Author collections: Bidhya Basnet · Dyuthi Yellamraju
FDA Dataset Walkthrough - Statistical Programming Perspectives
Source category: Submissions & Agencies
From FDA to PMDA submission: How to resolve CDISC non-compliance issues
Source category: Submission Standards
Generalisable Analysis Pipelines for Handling Large HTA Submissions
Source category: Poster Presentations
Author collections: Nicolai Skov Johnsen · Matthew Phelps
Generating Violin, eDISH, Box and Mean and Standard Deviation Line Graphs for Regulatory Submission: Comparison of SAS and R
Source category: Data Visualization
Author collections: Girija Javvaji
Guidelines for the Statistical Analysis in German Dossier Submissions
Source category: Statistics and Analytics
Handling CRS/NT Data in CAR-T Studies and Submission
Source category: Submission Standards
Author collections: Joe Xi · Yuanyuan Liu
Handling Multiple Adaptations in One Clinical Trial
Source category: Beyond Submissions Stories
Author collections: Parveen Kumar · Shrutimita Pokhariyal
Handling of Vaccine SDTM Data for FDA CBER/OVRR Submission Compliance
Source category: Submission Standards
Author collections: Pragathi Mudundi · Zhaoyu Xie