Novel Ways to Leverage Your Real-World Data Investment in Integrated Evidence Package Submissions
Source category: Poster Presentations
Author collections: Sherrine Eid
THE COMMUNITY ARCHIVE
Regulatory Submissions Papers and PresentationsPage 10
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 181–200
Piloting into the Future: Publicly available R-based Submissions to the FDA
Source category: Submission Standards
Author collections: Benjamin Straub
Speeding Up Submissions – Assessing the Business Value, Feasibility and Risk of New and Emerging Approaches
Source category: Submissions & Agencies
Author collections: Jaya Simha Inampudi · Nekzad Shroff
Streamlining MHRA Inspection Preparation and Execution in CROs
Source category: Submissions & Agencies
Author collections: Nicolas Rouillé
Study Start Date – Let’s Get it Right!
Source category: Submission Standards
Author collections: David Izard
Submitting Patient-Reported Outcome Data in Cancer Clinical Trials- Guidance for Industry Technical Specifications Document
Source category: Submission Standards
The Dataset-JSON Submission Process
Source category: Live Demonstartions
Author collections: Sarvar Khamidov · James Joseph
The Journey to Open Source Submission Readiness and Scalability
Source category: Submissions & Agencies
Author collections: Casey Higgins
The R Journey to Submission
Source category: Submissions & Agencies
Author collections: Hinal Patel · Jingyuan Chen
The State of Open-Source Technology in Clinical Data Analysis, Reporting and Submissions – A PHUSE Manuscript
Source category: Open Source Technologies
Author collections: Michael Rimler
Transforming RWD for Regulatory Submissions: How to Use SDTM for RWD
Source category: Standards Implementation
Author collections: Sam Hume · Tasha Nagamine
Transforming Submissions with Saama’s Biometrics Research Analysis and Information Network (BRAIN)
Source category: Software Demonstrations
Author collections: Jaya Simha Inampudi · Nekzad Shroff
Unlocking the Potential of Unstructured Data in Real-World Evidence: Leveraging Text for Enhanced Patient Classification and Regulatory Validation
Source category: Poster Presentations
Author collections: Georgios Panagiotakis · Maria Puri
Ups, Downs, and FDA Crowns - Lessons Learned from BIMO Submission Adventures!
Source category: Submissions & Agencies
A case study of a successful RTOR submission and approval for Rylaze
Source category: Submission Standards
Author collections: Sudhir Kedare · Jagan Mohan Achi
A Standard Dataset Format for the Validation of Tables and Listings in Regulatory Submissions for Clinical Trials
Source category: Poster Presentation
Author collections: Kevin Viel
ADaM Datasets with Multiple Participations per Subject
Source category: Submission Standards
Author collections: Grace Fawcett · Sandra Minjoe · Elizabeth Dennis
Adopting the New Integrated Analysis Data Reviewer’s Guide (iADRG)
Source category: Submission Standards
Author collections: Randi McFarland · Srinivas Kovvuri · Satheesh Avvaru
As Simple as Falling Off a Log?: An Unusual Case Study of Mapping Data into the SDTM DA (Drug Accountability) Domain
Source category: Submission Standards
Avoid Major Pitfalls When Using Real-World Evidence (RWE) in Regulatory Submissions
Source category: Real-world Evidence
Author collections: Mark Lambrecht