Automating of Two Key Components in Analysis Data Reviewer’s Guide
Source category: Data Visualization and Reporting
Author collections: Shunbing Zhao · Jeff Xia
THE COMMUNITY ARCHIVE
Regulatory Submissions Papers and PresentationsPage 19
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 361–380
Automating the Analysis Data Reviewer’s Guide (ADRG) in Early-stage Development Studies
Source category: Standards Implementation
Author collections: Jing Su · Pranab K. Mitra
Automation of Submission Package Quality Checks
Source category: Poster Presentation
Best Practices for Interactive Analyses for Decision-making & Submissions: An Update from the PHUSE Data Visualization Project... Paper includes comments
Source category: Data Visualisations
The publisher-listed Slides file is currently unavailable.
Challenges and solutions for e-data submission to PMDA even after submission to FDA
Source category: Submission Standards
Author collections: Akari Kamitani · Yura Suzuki · Malla Reddy Boda · Yoshitake Kitanishi
Complexities in Adhering to Data Standards for ISS NDA Submissions
Source category: Data Standards and Governance
Author collections: Vidya Muthukumar
Data Collection Time Point – Challenges with Analysis and Submission
Source category: Submissions & Agencies
Author collections: Aayush Bhoraskar
Data Review: What’s Not Included in Pinnacle 21?
Source category: Submission Standards
Author collections: Jinit Mistry · Lyma Faroz · Hao Meng
Data Standards Used for Electronic Submission of Real-world Evidence in New Drug Applications (NDAs)
Source category: Submissions & Agencies
Author collections: Nicole Thorne
Developing SEND for CBER – Collaborative Workstream Initiative Update
Source category: Submissions & Agencies
Author collections: Lisa Lin · Susan DeHaven
Drug Safety and Efficacy – Smart Regulatory Solution
Source category: Software Demonstration
Enabling Novel Digital Endpoints in Clinical Trials for Regulatory Purposes: Bringing Efficiency to the Industry by Creating a Service-based Ecosystem
Source category: Trends & Technology
Author collections: Bert Hartog · Kai Langel
End-to-end Prostate-Specific Antigen (PSA) Analysis in Clinical Trials: From Mock-ups to ADPSA
Source category: Submission Standards
Author collections: Joy Zeng · Varaprasad Ilapogu
FDA and PMDA Study Data Submission Distinctions
Source category: Poster Presentation
Author collections: Kiran Kundarapu
FDA Study Data Guidance Update
Source category: Submissions & Agencies
Author collections: Ethan Chen
FDA Study Data Submission Update
Source category: Standards Implementation
Author collections: Heather Crandall
Getting Closer to Multi-regional Clinical Trials
Source category: Submissions & Agencies
Author collections: Xiaohui Wang
Getting it Right: Refinement of SEND Validation Rules
Source category: Submissions & Agencies
Author collections: Kristin Kelly
Getting It Right: Refinement of SEND Validation Rules
Source category: Submission Standards
Author collections: Kristin Kelly
Getting It Right: Refinement of SEND Validation Rules
Source category: Submissions & Agencies
Author collections: Kristin Kelly