Snow White & the 7 Keys for Data Lake Hydration
Source category: Beyond Submissions Stories
Author collections: Chris Decker
THE COMMUNITY ARCHIVE
Regulatory Submissions Papers and PresentationsPage 13
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 241–260
Standardization of Reactogenicity Data into Findings
Source category: Submission Standards
Author collections: Charumathy Sreeraman
Study Data Technical Rejection Criteria (TRC) Considerations for Multiple Data Packages in a Single Submission
Source category: Submission Standards
Author collections: Christine Teng · Janet Low
Submission Experience with Real-Time Oncology Review, Project Orbis, and Priority Review
Source category: Submissions & Agencies
Submission Standards for Real-World Data: Gaps, Limitations and Recommendations
Source category: Real-world Evidence
Author collections: Jeffrey Abolafia · Sarah Ferko
Submission survival guidelines for Statistical Programmers
Source category: e-Posters
Author collections: Norihiko Oharu
Synthetic Control Arms: Are they the future of Drug Development?
Source category: Beyond Submissions Stories
Author collections: Sherrine Eid
The Journey of Preparing an ISS
Source category: Submissions & Agencies
Author collections: Lieke Gijsbers
Tips and traps on how to efficiently accelerate clinical trials to successful submission, approval, and launch
Source category: Strategic Implementation & Innovation
Author collections: Michael Nessly
Unleashing the Role of a Statistical Programmer in Expediting a Submission, Novartis
Source category: Submissions & Agencies
Author collections: Sowmya Singuluri
Use Python to Make Clinical Trial Result Posting Automatically
Source category: Beyond Submissions Stories
Author collections: Patty Hegarty
Using Python to Automate the Reviewer’s Guide
Source category: Scripts, Macros & Automation
Author collections: Matt Metherell · Simon Purkess
Using Real-world Data and Synthetic Data to Predict Study Outcomes, Submission Performance and Market Effectiveness
Source category: Emerging Trends
Author collections: Jose C. Lacal
Using SAS® to Prepare Postsecondary Data Partnership (PDP) Data Submission Files
Source category: Development and Support
Author collections: Bobbie Frye
We Can Work it Out: Dos and Don’ts for Small Biotech and CRO NDA/BLA submission partnership
Source category: Strategic Implementation & Innovation
Author collections: Charity Quick
Working Together: The Evolving Relationship of Biostatistics & Regulatory for Support of Study Data Standardization Plans and BIMO Reviewer's Guides
Source category: Submissions & Agencies
Author collections: David Izard
Working with Biomedical Concepts and SDTM Dataset Specializations for Define-XML using SAS© Open CST
Source category: Submission Standards
Author collections: Lex Jansen
A Better Way: eCOA/ePRO Annotated Screen Reports (aSRs) Provide Data Clarity from Data Collection to Submission
Source category: Data Handling
Author collections: Frank Menius
A Multilingual Shiny App for Drug Labelling in Worldwide Submission
Source category: Applications Development
Author collections: Aiming Yang · Yiwen Luo · Nan Xiao · Yilong Zhang
A Practical Approach to Preparing Documentation for Clinical Registries
Source category: Submission Standards
Author collections: Jennifer McGrogan · Mario Widel