Checking Outside the Box: A Framework for Submission Success
Source category: Submission Standards
Author collections: Julie Ann Hood · Seiko Yamazaki
THE COMMUNITY ARCHIVE
Regulatory Submissions Papers and PresentationsPage 5
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 81–100
clinify: Bridging the Gap in Regulatory-Compliant TFL Generation with R
Source category: OS
Author collections: Mike Stackhouse
Common Issues in BIMO Clinical Site Dataset Packages
Source category: Submission Standards
Author collections: Michael Beers
Competing on Products, Collaborating on Standards: An Approach to Harmonising Vaccine Regulatory Submissions
Source category: Data Standards & Governance
Considerations for the Submission of RWD Using CDISC, with Insights from HL7 FHIR and OMOP
Source category: Real-world Evidence
Author collections: Sarah Ferko · Ingeborg Holt
Considerations of R submission in Japan
Source category: e-Posters
Author collections: Yuichi Nakajima
Creating JSON Transport Data for Regulatory Life Sciences
Source category: Data Standards
Author collections: Mary Dolegowski · Matt Becker
Decoding the Role of Statistical Programming – A Decade of Keytruda Submissions and Approvals
Source category: Strategic Implementation & Innovation
Author collections: Mary Varughese · Hong Qi
Diversity, Inclusion and Equality Its Just Good Science!
Source category: Submissions & Agencies (SA)
Author collections: Roxanne McGuire
Double Trouble: Essential Insights from Successful Dual sBLA Submissions for a Drug-Device Combo
Source category: Submissions & Agencies
E2E R Submission from a Roche Oncology Study
Source category: Submissions & Agencies
Author collections: Jingyuan Chen · Hinal Patel
Efficient Conversion of SDTM/ADaM Specifications from Excel to Define-XML v2.1 Using Pinnacle 21 Community
Source category: Submissions & Agencies (SA)
Author collections: Seiko Yamazaki
Efficient Strategies for Handling Data Issues in Clinical Trial Submissions
Source category: e-Posters
Enhancing Pharmaceutical Quality Assurance Through Large Language Models: A Novel Approach to Intelligent Regulatory Monitoring
Source category: Machine Learning, AI and Large Language Models
Ensuring Data Integrity: Techniques for Validating SDTM Datasets in Clinical Research
Source category: Submission Standards
Evaluation of the Process to Create CLINSITE define.xml: Macro Approach vs. ADCLIN Spec
Source category: Submission Standards
Author collections: Yizhuo Zhong · Yunyi Jiang · Christine Teng
Expediting the Regulatory Submission Process Through Automated Tools
Source category: Poster Presentations
Author collections: Manish Deole · Gautham Selvaraj
Exploring the Upcoming Integrated cSDRG!
Source category: Submission Standards
Author collections: Srinivas Kovvuri · Christine McNichol · Randi McFarland · Kiran Kundarapu · Satheesh Avvaru
FHIR for RWD Submissions: Why a US Regulation Signals a Global Shift And What You Need To Do Now
Source category: Real-world Evidence (RE)
Author collections: Sanyogeeta Andhale
From Application to Approval: Exploring the FDA’s Review Process
Source category: Submissions & Agencies