Helping You Get in the Lightning Lane for a Wild Submissions Ride!
Source category: Submissions & Agencies
Author collections: Ali Dootson
THE COMMUNITY ARCHIVE
Regulatory Submissions Papers and PresentationsPage 12
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 221–240
How Can I Put This? – Using a pre-defined spreadsheet to explain your Pinnacle 21 Enterprise Issues
Source category: Submission Standards
Author collections: Mike Lozano
How to Prepare Precise and Intact Software Program for Submission
Source category: Industry Applications
Industry metrics for standards utilization and validation rules
Source category: Submission Standards
Author collections: Sergiy Sirichenko
Innovate Clinical Trial Reporting with Open Source
Source category: Beyond Submissions Stories
Author collections: Soma Sekhar Sriadibhatla · Francis Kendall
Interaction with the FDA During and After a Type C Meeting, From the Perspective of a Statistical Programmer
Source category: Submissions & Agencies
Introducing Gtreg: an R Package to Produce Regulatory Tables for Clinical Research
Source category: Open Source Technologies
Author collections: Daniel Sjoberg
Investigator Initiated Trials: Turbulence ahead!
Source category: Submissions & Agencies
It’s Easy Peasy Submitting Data to the China NMPA – Really?
Source category: Submissions & Agencies
Author collections: Nigel Montgomery
Keynote01: Reimagining Regulatory Data Submissions Modernizing – partnering and exploring how regulatory data could be shared with HAs
Source category: Conference presentation
Next-generation Data Architecture for Clinical Data Review and Submission
Source category: Data Handling
Author collections: Aman Thukral
Optimizing Efficiency and Improving Data Quality through Meaningful Custom Fix Tips and Explanations
Source category: Submission Standards
Author collections: Jennifer Manzi · Julie Ann Hood
Practical Operations of Electronic Study Data Submissions
Source category: Submissions & Agencies
Proposal for New ADaM Paired Variables: PARQUAL/PARTYPE
Source category: Submission Standards
Author collections: Elizabeth Dennis · Paul Slagle
R Tables via GT for Regulatory Submissions
Source category: Quick Programming Tips
Author collections: Phil Bowsher
Recent updates in BIMO Technical conformance guidance and use case scenario
Source category: Submission Standards
Author collections: Sreedhar Bodepudi
Regulating the Future: Navigating the Complexities of 3D Printing in the Pharmaceutical Industry
Source category: Submissions & Agencies
Regulatory Data Submission and CDISC Compliance: Sponsor and Vendor Collaboration Best Practices
Source category: Submission Standards
Author collections: Tabassum Ambia
SDTM CRT Packages and the Submission Space
Source category: Poster Presentations
Shiny for Submissions
Source category: Emerging Trends
Author collections: Philip Bowsher