Dec 05, 2023
In today’s evolving clinical research and drug development landscape, with more data sources and technology...
Jul 24, 2023
For many sponsors of clinical trials, particularly the smaller pharmaceutical, biotech, and medical device companies,...
May 22, 2023
Background In October 2022, Abiomed, a leading provider of medical technology focused on mechanical circulatory...
Feb 01, 2023
by Sharon Rossouw EXECUTIVE SUMMARY Data standards support the robust organization, analysis, and reporting of...
Dec 22, 2022
Introduction The submission of a New Drug Application (NDA) to regulatory authorities and its subsequent...
Nov 08, 2022
Background When a patient presents with a fever or what appears to be an acute...
Jan 17, 2022
Ensuring Clinical Trial Data Integrity: Five Things to Remember When Selecting a CRO Partner ...
May 19, 2019
In light of regulatory requirements, CDISC SDTM is now the leading standard for representing clinical...
Oct 24, 2018
The International Conference on Harmonization Good Clinical Practice (ICH-GCP) defines the Sponsor of a clinical...
Oct 24, 2018
Clinical study data is defined by the FDA as information about a person in a...
Oct 24, 2018
The FDA has recently published a new version of the Technical Conformance Guide (TCG) with updates that...
Oct 24, 2018
The SDSP (Study Data Standardization Plan) is a document intended to communicate to CDER (Center for...