Submit RFP/RFI
Submit RFP/RFI
Search
Submit RFP/RFI
Submit RFP/RFI
Search
Submit RFP/RFI
Submit RFP/RFI
Search

Navigating Complexities: Integrating Data from Ongoing Studies in Regulatory Submissions

Natalie Freeland, Associate Director, Statistical Programming

CDISC+TMF Presentation

October 2024

Natalie Freeland, Associate Director, Statistical Programming

CDISC+TMF Presentation

October 2024

Related insights

Study Data Standardization Plan (SDSP) – What it is and why it’s needed?  
According to the Study Data Technical Conformance Guide (October 2024), sponsors should prepare a document called the
Read More
Blog
Traceability: The Breadcrumb Trail of Clinical Trial Data 
Most of those who work with Clinical Data Interchange Standards Consortium (CDISC) datasets have probably heard of
Read More
Blog
Maximizing the Use of Real-World Data (RWD): Beyond the Theory 
Real-world data (RWD) has become a buzzword phrase in recent articles in clinical trial research. But there
Read More
Blog
Splitting SDTM Datasets Using a Data Cutoff for Submission 
In complex or longer duration clinical studies, it is common to submit the data up to a
Read More
Blog
New Drug Applications – When is it ok to not submit data to FDA? 
New Drug Applications - When is it ok to not submit data to FDA? Generally speaking, the
Read More
Blog
Successful Pediatric Investigation Plan (PIP) Application in the European Union – Part 1: Understanding the regulatory requirements
Regulation (EC) No 1901/2006 (the “Pediatric Regulation”) introduced the obligation for Sponsors to apply for a pediatric
Read More
Blog

© 2025 Rho, Inc. All rights reserved.

Scroll to Top